85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212

  
372 trials found
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1NCT05571059
(ClinicalTrials.gov)
June 202327/9/2022Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo-Controlled Phase II Study With an Open-Label Extension to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Ifetroban Sodium;Drug: PlaceboCumberland PharmaceuticalsNULLNot yet recruiting40 Years80 YearsAll128Phase 2NULL
2NCT05674994
(ClinicalTrials.gov)
March 15, 20239/12/2022Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary FibrosisGlucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled TrialAcute Exacerbation of Idiopathic Pulmonary FibrosisDrug: Methylprednisone/Prednisone;Other: PlaceboGroupe Hospitalier Paris Saint JosephNULLNot yet recruiting18 YearsN/AAll110Phase 3France
3NCT05195918
(ClinicalTrials.gov)
March 1, 20232/12/2021Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF PatientsDose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug EffectIdiopathic Pulmonary FibrosisCombination Product: EGCG 300 mg + Nintedanib;Combination Product: EGCG 300 mg + Pirfenidone;Combination Product: Placebo 2 capsules + Nintedanib or Pirfenidone;Combination Product: EGCG 600 mg + Nintedanib;Combination Product: EGCG 600 mg + Pirfenidone;Combination Product: Placebo 4 capsules + Nintedanib or PirfenidoneHal ChapmanUniversity of Michigan;Cornell University;Massachusetts General Hospital;Temple University;University of WashingtonNot yet recruiting40 Years85 YearsAll50Phase 1United States
4NCT05349760
(ClinicalTrials.gov)
March 202331/3/2022A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary FibrosisIPFBiological: AMB-05X;Drug: PlaceboAmMax Bio, Inc.NULLWithdrawn40 YearsN/AAll0Phase 2NULL
5NCT05671835
(ClinicalTrials.gov)
March 20233/1/2023Study of TTI-101 in Participants With Idiopathic Pulmonary FibrosisREVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: TTI-101;Drug: PlaceboTvardi Therapeutics, IncorporatedNULLRecruiting40 YearsN/AAll100Phase 2United States
6NCT05483907
(ClinicalTrials.gov)
February 21, 202327/7/2022To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPFA Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: BBT-877;Drug: PlaceboBridge Biotherapeutics, Inc.NULLRecruiting40 YearsN/AAll120Phase 2United States;Australia;Israel
7NCT05722964
(ClinicalTrials.gov)
February 202311/1/2023Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of Intravenous Infusion of SHR-1906 in Patients With Idiopathic Pulmonary Fibrosis: a Multicenter, Randomized, Double-blind, Parallel Placebo-controlled Phase II TrialIdiopathic Pulmonary FibrosisDrug: SHR-1906;Drug: PlaceboGuangdong Hengrui Pharmaceutical Co., LtdNULLNot yet recruiting40 Years80 YearsAll108Phase 2NULL
8NCT05537025
(ClinicalTrials.gov)
January 30, 20238/9/2022Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary FibrosisA Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: ARO-MMP7 Inhalation Solution;Drug: PlaceboArrowhead PharmaceuticalsNULLRecruiting18 YearsN/AAll77Phase 1/Phase 2New Zealand
9EUCTR2022-001091-34-DK
(EUCTR)
26/01/202313/12/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
10NCT05513950
(ClinicalTrials.gov)
January 25, 202317/8/2022A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPFA Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Intravenous Monoclonal Antibody (mAB) After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: CHF10067 starting dose;Biological: CHF10067 intermediate dose;Biological: CHF10067 high dose;Drug: PlaceboChiesi Farmaceutici S.p.A.NULLRecruiting40 Years80 YearsAll24Phase 1United Kingdom
11EUCTR2021-006820-41-GR
(EUCTR)
23/12/202216/09/2022A Randomized Double-blind Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary FibrosisA Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis (IPF);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: deupirfenidone
Product Code: LYT-100
INN or Proposed INN: deupirfenidone
Other descriptive name: Pirfenidone, deuterated
Product Name: pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: Pirfenidone
PureTech LYT 100, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Czechia;Taiwan;Greece;Thailand;Chile;Colombia;India;Mexico;Argentina;Malaysia;Poland;Romania;Georgia;Korea, Republic of
12EUCTR2022-001091-34-GR
(EUCTR)
21/12/202202/11/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim B.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
13EUCTR2022-001091-34-IE
(EUCTR)
19/12/202228/07/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - FIBRONEER-IPF Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Germany;Japan;New Zealand;Sweden;Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway
14EUCTR2022-001091-34-NL
(EUCTR)
05/12/202213/10/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: Not assigned yet
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: Not assigned yet
Other descriptive name: BI 1015550
Boehringer Ingelheim BV NetherlandsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
15NCT05497284
(ClinicalTrials.gov)
November 10, 20225/8/2022To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPFA Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: LTP001;Drug: Placebo;Drug: Standard of Care (SoC)Novartis PharmaceuticalsNULLRecruiting40 YearsN/AAll94Phase 2United States;Argentina;Australia
16NCT05255991
(ClinicalTrials.gov)
October 4, 202215/2/2022Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)Idiopathic Pulmonary Fibrosis;Interstitial Lung DiseaseDrug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic NebulizerUnited TherapeuticsNULLRecruiting40 YearsN/AAll396Phase 3Argentina;Australia;Chile;Denmark;France;Israel;Korea, Republic of;Mexico;Spain;Taiwan
17NCT05321069
(ClinicalTrials.gov)
September 19, 20224/4/2022A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLRecruiting40 YearsN/AAll963Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;China;Denmark;Estonia;Finland;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Singapore;Spain;Sweden;Taiwan;Thailand;United Kingdom
18EUCTR2021-005881-17-DK
(EUCTR)
12/09/202215/07/2022A study evaluating the efficacy and safety of inhaled treprostinil in subjects with idiopathic pulmonary fibrosisA Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2) Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: TYVASO® (treprostinil) inhalation solution, for oral inhalation use
Product Name: Treprostinil
INN or Proposed INN: Treprostinil
UNITED THERAPEUTICS CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
396Phase 3Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Denmark;Australia;Peru;Germany;Netherlands;New Zealand;Korea, Republic of
19NCT05570058
(ClinicalTrials.gov)
September 8, 202228/9/2022Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary FibrosisA Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary FibrosisIPF;FibrosisDrug: RXC007;Drug: PlaceboRedx Pharma PlcSimbec ResearchRecruiting40 Years80 YearsAll64Phase 2Belgium;Czechia;Italy;Spain;United Kingdom
20EUCTR2021-006278-22-NL
(EUCTR)
29/08/202201/06/2022A study to find out if orvepitant is safe to use and reduces the severity of cough in patients with idiopathic pulmonary fibrosisA DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, TWO PERIOD CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORVEPITANT IN CHRONIC COUGH IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Chronic cough in patients with idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Orvepitant
INN or Proposed INN: ORVEPITANT
Product Name: Orvepitant
INN or Proposed INN: ORVEPITANT
NeRRe Therapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 2United States;Netherlands;United Kingdom
21NCT05185089
(ClinicalTrials.gov)
August 1, 202223/12/2021Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary FibrosisA Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary FibrosisCough;Idiopathic Pulmonary FibrosisDrug: Orvepitant Maleate;Drug: PlaceboNerre Therapeutics Ltd.Pharm-Olam InternationalRecruiting40 YearsN/AAll88Phase 2United States;Netherlands;United Kingdom
22NCT05389215
(ClinicalTrials.gov)
July 29, 202217/4/2022Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPFA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: DWN12088;Drug: PlaceboDaewoong Pharmaceutical Co. LTD.NULLRecruiting40 YearsN/AAll102Phase 2United States;Korea, Republic of
23NCT05321420
(ClinicalTrials.gov)
July 29, 20222/4/2022LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Placebo;Drug: Pirfenidone;Drug: DeupirfenidonePureTechNULLRecruiting40 YearsN/AAll240Phase 2United States;Argentina;Georgia;Greece;India;Malaysia;Romania;Thailand
24NCT05621252
(ClinicalTrials.gov)
July 13, 20222/11/2022Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: PLN-74809;Drug: PlaceboPliant Therapeutics, Inc.NULLRecruiting40 YearsN/AAll12Phase 2United States
25NCT05427253
(ClinicalTrials.gov)
June 15, 20227/6/2022First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy SubjectsA Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female SubjectsSafety Issues;Tolerance;Idiopathic Pulmonary Fibrosis;Pulmonary HypertensionDrug: C106 solution;Drug: PlaceboVicore Pharma ABNULLRecruiting18 Years65 YearsAll72Phase 1Sweden
26NCT05387785
(ClinicalTrials.gov)
June 202217/5/2022Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Arm, 4-Sequence, Crossover Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ang-3070 in Subjects With Idiopathic Pulmonary Fibrosis Who Are Treatment-Naïve or Who Have Failed or Refused Standard of Care TreatmentIdiopathic Pulmonary Fibrosis (IPF)Drug: ANG-3070;Drug: PlaceboAngion Biomedica CorpNULLNot yet recruiting40 YearsN/AAll20Phase 1NULL
27NCT05373914
(ClinicalTrials.gov)
May 31, 202210/5/2022RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF)RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Cudetaxestat (BLD-0409);Drug: Control: Matching PlaceboBlade TherapeuticsNULLNot yet recruiting40 Years85 YearsAll200Phase 2NULL
28EUCTR2021-003162-12-DK
(EUCTR)
21/04/202210/12/2021CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Factor XIIa antagonist monoclonal antibody
Product Code: CSL312 Garadacimab
INN or Proposed INN: FXIIa inhibitor monoclonal antibody
Other descriptive name: Garadacimab
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Czechia;Spain;Ukraine;Lithuania;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Latvia;Netherlands;Sweden
29EUCTR2021-001253-32-NL
(EUCTR)
11/04/202219/01/2022A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Netherlands;Germany;Korea, Republic of
30EUCTR2021-001253-32-GR
(EUCTR)
04/03/202227/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Germany;Netherlands;Korea, Republic of
31NCT05154240
(ClinicalTrials.gov)
February 21, 202217/11/2021A Phase 1, Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Oral Single and Multiple Ascending Doses, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy SubjectsIdiopathic Pulmonary FibrosisDrug: INS018_055;Drug: PlaceboInSilico Medicine Hong Kong LimitedNULLRecruiting18 Years55 YearsAll80Phase 1New Zealand
32EUCTR2021-001253-32-ES
(EUCTR)
16/02/202207/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Korea, Republic of
33NCT05130970
(ClinicalTrials.gov)
January 27, 202212/11/2021CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: CSL312;Drug: PlaceboCSL BehringNULLRecruiting40 YearsN/AAll80Phase 2United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Poland;Spain;United Kingdom
34JPRN-jRCT2051210169
16/01/202205/02/2022A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary FibrosisPamrevlumab or placebo, 30 mg/kg, IV, Day 1 and every 3 weeks thereafter, up to Week 48, for a total of up to 17 infusions.Tracy GanskeNULLRecruiting>= 40age old<= 85age oldBoth34Phase 3United States;Argentina;Chile;Russia;Australia;Taiwan;Hong Kong;South Korea;the People's Republic of China;Japan
35NCT03720483
(ClinicalTrials.gov)
January 202218/7/2018Inhaled NAC in Treatment of IPFPilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: N-acetyl cysteine then Placebo;Drug: Placebo then N-acetyl cysteineUniversity of Colorado, DenverNULLWithdrawn40 Years75 YearsAll0Phase 1/Phase 2United States
36JPRN-jRCT2051210129
05/12/202105/12/2021A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE)A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) - WA42293 Idiopathic pulmonary fibrosisRO7490677 (PRM-151) is administered intravenously at 10 mg / kg every 4 weeks for 48 weeks.Makino RyokoNULLRecruiting>= 40age old<= 85age oldBoth60Phase 3Spain;Sweden;Japan;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa
37NCT05134727
(ClinicalTrials.gov)
November 18, 202115/11/2021Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy ParticipantsA Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending DosesIdiopathic Pulmonary FibrosisDrug: AZD5055;Drug: PlaceboAstraZenecaNULLRecruiting18 Years55 YearsAll90Phase 1United States
38NCT05119972
(ClinicalTrials.gov)
October 21, 20219/10/2021Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: ZSP1603;Drug: PlaceboGuangdong Raynovent Biotech Co., LtdNULLRecruiting40 YearsN/AAll36Phase 1/Phase 2China
39NCT05022771
(ClinicalTrials.gov)
October 14, 202120/8/2021A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: PMG1015 Dose 1;Drug: PMG1015 Dose 2;Drug: PMG1015 Dose 3;Drug: PMG1015 Dose 4;Drug: PMG1015 Dose 5;Drug: PMG1015 Dose 6;Drug: Placebo;Drug: PMG1015 Dose 7Pulmongene Ltd.NULLCompleted18 Years60 YearsAll54Phase 1Australia
40NCT04968574
(ClinicalTrials.gov)
August 26, 202129/6/2021A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: taladegib;Drug: placeboEndeavor Biomedicines, Inc.NULLRecruiting40 YearsN/AAll60Phase 2Australia;Canada;Korea, Republic of;Malaysia;Mexico
41NCT05032066
(ClinicalTrials.gov)
August 25, 202127/8/2021A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: HZN-825;Drug: PlaceboHorizon Therapeutics Ireland DACNULLRecruiting18 YearsN/AAll135Phase 2United States;Argentina;Australia;Canada;Chile;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;South Africa;Spain;Taiwan;Turkey
42NCT04986540
(ClinicalTrials.gov)
August 10, 202127/7/2021A Trial of SHR - 1906 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy SubjectsIdiopathic Pulmonary FibrosisDrug: SHR-1906;PlaceboGuangdong Hengrui Pharmaceutical Co., LtdNULLCompleted18 Years55 YearsAll72Phase 1China
43EUCTR2020-000791-38-DK
(EUCTR)
06/08/202111/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 160mg/8mL
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 320mg/16mL (2nd generation)
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden
44NCT04965298
(ClinicalTrials.gov)
June 16, 20217/7/2021Treating People With Idiopathic Pulmonary Fibrosis With the Addition of LansoprazoleThe Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole: a Randomised Placebo-controlled Multi-centre Clinical TrialIdiopathic Pulmonary FibrosisDrug: Lansoprazole;Other: Matched placeboNorfolk and Norwich University Hospitals NHS Foundation TrustNorwich Clinical Trials UnitRecruiting40 YearsN/AAll298Phase 3United Kingdom
45NCT04708782
(ClinicalTrials.gov)
June 1, 202112/1/2021Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Interstitial Lung DiseaseDrug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic NebulizerUnited TherapeuticsNULLRecruiting40 YearsN/AAll396Phase 3United States
46EUCTR2020-000791-38-DE
(EUCTR)
28/05/202102/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 160 mg/8mL
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 320mg/16mL (2nd generation)
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden
47EUCTR2020-000791-38-NO
(EUCTR)
25/05/202108/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Korea, Republic of;Czechia;Finland;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
48NCT04931147
(ClinicalTrials.gov)
May 13, 20214/6/2021A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy VolunteersA Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male ParticipantsFibrosis;Inflammation;Idiopathic Pulmonary Fibrosis;Non-alcoholic Steatohepatitis;Liver Diseases;Kidney DiseasesDrug: RXC007;Drug: RXC007 Matching PlaceboRedx Pharma PlcSimbec ResearchRecruiting18 Years55 YearsMale80Phase 1United Kingdom
49EUCTR2020-000697-22-IE
(EUCTR)
04/05/202102/12/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
50EUCTR2020-000791-38-NL
(EUCTR)
29/04/202121/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: Zinpetraxin Alfa
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden
51EUCTR2020-000791-38-SE
(EUCTR)
14/04/202127/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 160mg/8mL
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 320mg/16mL (2nd generation)
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Norway;New Zealand;Sweden
52EUCTR2020-000697-22-PL
(EUCTR)
13/04/202103/12/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;India;France;Peru;Denmark;Netherlands;Czechia;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Poland;Dominican Republic;Bulgaria;Georgia;Germany;Norway
53EUCTR2019-004167-45-CZ
(EUCTR)
12/04/202118/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
54EUCTR2020-000791-38-PT
(EUCTR)
19/03/202117/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
55NCT04552899
(ClinicalTrials.gov)
March 19, 202114/9/2020A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary FibrosisA Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: PRM-151 (Zinpentraxin Alfa);Drug: PlaceboHoffmann-La RocheNULLCompleted40 Years85 YearsAll665Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Singapore;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Peru;Puerto Rico;Russian Federation
56EUCTR2020-000791-38-FI
(EUCTR)
16/03/202109/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 160 mg/8 ml
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 320 mg/16 ml (2nd generation)
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden
57EUCTR2020-000791-38-GR
(EUCTR)
18/02/202107/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 160mg/8mL
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677 320mg/16mL (2nd generation)
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden
58EUCTR2019-002709-23-NL
(EUCTR)
16/02/202106/08/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-020
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand;Italy;Korea, Republic of
59NCT04643769
(ClinicalTrials.gov)
February 9, 202111/11/2020Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: ORIN1001;Drug: PlaceboOrinove, Inc.Vanderbilt UniversityActive, not recruiting40 Years80 YearsAll24Phase 1United States
60EUCTR2020-000791-38-HU
(EUCTR)
05/02/202104/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
658Phase 3France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden;Switzerland;Italy;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel
61JPRN-jRCT2031210008
27/01/202102/04/2021A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary FibrosisThis clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo).Kayamori TakefumiNULLNot Recruiting>= 40age oldNot applicableBoth49Phase 3Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey
62EUCTR2020-000791-38-PL
(EUCTR)
22/01/202119/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
63EUCTR2020-000791-38-CZ
(EUCTR)
20/01/202130/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: RO7490677
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden
64EUCTR2019-002709-23-IT
(EUCTR)
29/12/202024/05/2021A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN 74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) - INTEGRIS-IPF idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: [PLN-74809]
Other descriptive name: PLN-74809-000
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
65EUCTR2020-000697-22-NL
(EUCTR)
24/12/202004/06/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
66EUCTR2020-000791-38-IT
(EUCTR)
21/12/202015/06/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - - Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Recombinant human Pentraxin-2 (PRM-151)
Product Code: [RO7490677]
INN or Proposed INN: Recombinant human Pentraxin-2
Other descriptive name: PRM-151
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden
67EUCTR2019-002709-23-DE
(EUCTR)
18/12/202031/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 inparticipants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-020
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy;Korea, Republic of
68NCT04429516
(ClinicalTrials.gov)
December 17, 202012/3/2020Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis CoughPAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis CoughIdiopathic Pulmonary FibrosisDrug: Morphine Sulfate;Drug: Placebo oral tabletRoyal Brompton & Harefield NHS Foundation TrustNULLRecruiting40 Years90 YearsAll44Phase 3United Kingdom
69EUCTR2019-004167-45-GR
(EUCTR)
17/12/202003/12/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
70NCT04300920
(ClinicalTrials.gov)
December 17, 20206/3/2020Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialProspective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialIdiopathic Pulmonary FibrosisDrug: N-acetyl cysteine;Drug: PlaceboWeill Medical College of Cornell UniversityUniversity of Virginia;University of Michigan;Pulmonary Fibrosis Foundation;University of Washington;National Heart, Lung, and Blood Institute (NHLBI);Three Lakes FoundationRecruiting40 YearsN/AAll200Phase 3United States
71EUCTR2019-003992-21-IT
(EUCTR)
15/12/202030/08/2021A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: [BMS-986278]
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: [BMS-986278]
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of
72NCT04598919
(ClinicalTrials.gov)
November 12, 202015/9/2020Saracatinib in the Treatment of Idiopathic Pulmonary FibrosisUse of the Src Family Kinase Inhibitor Saracatinib in the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Saracatinab;Drug: PlaceboNational Jewish HealthYale University;Icahn School of Medicine at Mount Sinai;AstraZeneca;National Center for Advancing Translational Sciences (NCATS);Baylor University;International Center for Health Outcomes and Innovation ResearchRecruiting40 YearsN/AAll49Phase 1/Phase 2United States
73EUCTR2019-002709-23-GB
(EUCTR)
06/11/202024/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-000
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not available
Other descriptive name: PLN-74809-000
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not Available
Other descriptive name: PLN-74809-000
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
74EUCTR2019-004167-45-SK
(EUCTR)
02/11/202011/08/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
75EUCTR2019-004167-45-AT
(EUCTR)
23/10/202006/07/2020A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
76NCT04589260
(ClinicalTrials.gov)
October 15, 20208/10/2020TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary FibrosisA Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 3-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C)Idiopathic Pulmonary Fibrosis (IPF)Drug: TD-1058;Drug: PlaceboTheravance BiopharmaNULLRecruiting18 YearsN/AAll96Phase 1United Kingdom
77EUCTR2020-000697-22-DE
(EUCTR)
13/10/202005/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
78EUCTR2020-000697-22-DK
(EUCTR)
13/10/202014/08/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Denmark;Peru;Georgia;Netherlands;Germany
79NCT04419558
(ClinicalTrials.gov)
September 30, 20203/6/2020Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLRecruiting40 Years85 YearsAll340Phase 3United States;Argentina;Brazil;China;Colombia;Czechia;Denmark;Dominican Republic;France;Georgia;Germany;Hungary;Ireland;Italy;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Serbia;Spain;Switzerland;Ukraine;United Kingdom
80NCT04497831
(ClinicalTrials.gov)
September 21, 202025/7/2020Morphine for Dyspnea in Pulmonary FibrosisDetermining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Morphine hydrochloride;Drug: PlaceboMedical University of GdanskNULLNot yet recruiting18 YearsN/AAll20Phase 3NULL
81NCT04312594
(ClinicalTrials.gov)
September 8, 202027/2/2020Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Trial of Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets;Drug: Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets;Drug: Placebo oral tablet and Acetylcysteine Effervescent TabletsSuzhou Zelgen Biopharmaceuticals Co.,LtdNULLRecruiting50 YearsN/AAll90Phase 2China
82NCT03865927
(ClinicalTrials.gov)
September 7, 20201/3/2019GKT137831 in IPF Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisOther: Placebo Oral Tablet;Drug: GKT137831University of Alabama at BirminghamNULLRecruiting40 Years85 YearsAll60Phase 2United States
83EUCTR2019-004167-45-DK
(EUCTR)
27/08/202012/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
84EUCTR2019-004167-45-PL
(EUCTR)
24/08/202014/07/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
85EUCTR2019-004167-45-GB
(EUCTR)
19/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
86EUCTR2019-004167-45-HU
(EUCTR)
17/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
87EUCTR2019-003992-21-DE
(EUCTR)
06/08/202027/05/2020A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of
88EUCTR2019-004167-45-DE
(EUCTR)
30/07/202022/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
89EUCTR2020-000697-22-IT
(EUCTR)
29/07/202021/01/2021A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). - Zephyrus II Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Poland;Brazil;Belgium;Dominican Republic;Denmark;Peru;Georgia;Bulgaria;Norway;Netherlands;Germany
90NCT04419506
(ClinicalTrials.gov)
July 28, 20204/6/2020A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken OrallyIdiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll147Phase 2United States;Argentina;Australia;Austria;Canada;Chile;China;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
91EUCTR2019-004998-34-GB
(EUCTR)
16/07/202004/02/2020A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary FibrosisA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis - B-2660-203 Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BLD-2660
Product Code: BLD-2660
INN or Proposed INN: None
Other descriptive name: BLD-2660
Blade Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom
92NCT04512170
(ClinicalTrials.gov)
July 13, 20207/8/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female SubjectsA Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label,Crossover, Food Effect Study of HEC585 in Healthy Chinese SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585;Drug: placeboSunshine Lake Pharma Co., Ltd.NULLCompleted18 Years45 YearsAll72Phase 1China
93EUCTR2019-004167-45-IT
(EUCTR)
09/07/202017/06/2021A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. - - Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
94EUCTR2019-004167-45-NL
(EUCTR)
09/07/202012/05/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
95EUCTR2020-000697-22-HU
(EUCTR)
08/07/202022/05/2020A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis.Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
96EUCTR2019-003992-21-BE
(EUCTR)
03/07/202004/05/2020A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis Pulmonary Fibrosis
MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Product Name: BMS-986278
Product Code: BMS-986278
INN or Proposed INN: LPA1
Other descriptive name: BMS-986278
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Japan;Korea, Republic of
97EUCTR2020-000041-14-GB
(EUCTR)
19/06/202008/07/2020Treating people with Idiopathic Pulmonary fibrosis with the Addition of LansoprazoleThe effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): a randomised placebo-controlled multi-centre clinical trial - TIPAL Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Lansoprazole
Product Name: Lansoprazole
INN or Proposed INN: lansoprazole
Other descriptive name: N/A
Norfolk and Norwich University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
298Phase 3United Kingdom
98EUCTR2018-002664-73-IE
(EUCTR)
25/05/202020/12/2018Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks Patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Georgia;Germany
99EUCTR2019-003571-19-GB
(EUCTR)
21/05/202027/02/2020A multicentre, double blind, placebo controlled, crossover trial of morphine sulphate sulfate for the treatment of PulmonAry Fibrosis Cough (PAciFy Cough Trial)PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Morphine Sulfate
Product Name: Morphine Sulfate
INN or Proposed INN: morphine sulfate
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 3United Kingdom
100EUCTR2019-004167-45-FI
(EUCTR)
18/05/202015/04/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
101NCT04233814
(ClinicalTrials.gov)
January 20, 202012/1/2020Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult SubjectsIdiopathic Pulmonary FibrosisDrug: Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03);Drug: PlaceboLung Therapeutics, IncNULLCompleted18 Years55 YearsAll71Phase 1United Kingdom
102NCT04244825
(ClinicalTrials.gov)
December 15, 20193/1/2020Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPFA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BLD-2660;Drug: Control: PlaceboBlade TherapeuticsNULLWithdrawn45 YearsN/AAll0Phase 2United Kingdom
103NCT04720443
(ClinicalTrials.gov)
November 22, 201930/12/2020A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal SubjectsA Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses.Idiopathic Pulmonary FibrosisDrug: NIP292 tablet;Drug: NIP292 tabletsThe National Institutes of Pharmaceutical R&D Co. Ltd, ChinaNULLRecruiting18 Years55 YearsAll72Phase 1United States
104EUCTR2018-002664-73-GB
(EUCTR)
24/09/201922/01/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;France;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;Italy;United Kingdom
105EUCTR2017-004302-18-RO
(EUCTR)
30/08/201924/05/2022A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Croatia;Romania;Bulgaria;Sweden
106NCT04030026
(ClinicalTrials.gov)
August 8, 201911/7/2019A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of CoughPhase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of CoughNalbuphine;Idiopathic Pulmonary Fibrosis;CoughDrug: Nalbuphine ER;Drug: Placebo oral tabletTrevi TherapeuticsParexelCompleted18 Years80 YearsAll42Phase 2United Kingdom
107EUCTR2018-002664-73-IT
(EUCTR)
17/07/201915/01/2021Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks - - patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: [TD139]
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: [TD139]
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2France;United States;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;United Kingdom;Italy
108EUCTR2018-002664-73-PL
(EUCTR)
09/07/201914/03/2019Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
141Phase 2United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Georgia;Germany
109EUCTR2018-002664-73-FR
(EUCTR)
09/07/201922/01/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Poland;Belgium;Spain;Israel;Germany;Italy;United Kingdom
110NCT03562416
(ClinicalTrials.gov)
July 5, 20197/5/2018Continuation of Nintedanib After Single Lung Transplantation in IPF SubjectsNintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled TrialIdiopathic Pulmonary Fibrosis;Lung Transplant; ComplicationsDrug: Nintedanib;Drug: Placebo Oral TabletTemple UniversityBoehringer IngelheimRecruiting35 Years70 YearsAll20Phase 2United States
111EUCTR2018-004447-23-DE
(EUCTR)
04/07/201907/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy
112EUCTR2018-004744-31-GB
(EUCTR)
24/06/201905/03/2019Efficacy and Safety Study: Nalbuphine ER Tablets for the Treatment of Cough in Idiopathic Pulmonary FibrosisA Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment of Cough - CANAL Treatment of Cough in Idiopathic Pulmonary Fibrosis;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]Product Name: Nalbuphine Extended-Realease (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Product Name: Nalbuphine Extended-Release (ER) Tablets
Product Code: TR0311
INN or Proposed INN: Nalbuphine
Other descriptive name: NALBUPHINE HYDROCHLORIDE
Trevi Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United Kingdom
113EUCTR2018-004447-23-IT
(EUCTR)
18/06/201910/11/2020Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
INN or Proposed INN: cromoglicato disodico
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences, GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
114NCT03955146
(ClinicalTrials.gov)
June 18, 201916/5/2019Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: PlaceboFibroGenNULLActive, not recruiting40 Years85 YearsAll356Phase 3United States;Argentina;Australia;Chile;China;Hong Kong;Korea, Republic of;Russian Federation;Taiwan;Czechia;France;Germany;Hungary;Italy;Japan;Lebanon;Netherlands;Peru;Spain
115EUCTR2018-001405-87-BE
(EUCTR)
27/05/201928/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
116EUCTR2018-004447-23-GB
(EUCTR)
20/05/201915/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial RESPIVANT RVT1601-cc-04 Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
117EUCTR2018-004447-23-CZ
(EUCTR)
15/05/201914/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
118EUCTR2018-004447-23-BE
(EUCTR)
02/05/201901/04/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
119EUCTR2017-003158-18-DE
(EUCTR)
30/04/201921/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
120NCT03949530
(ClinicalTrials.gov)
April 16, 20196/5/2019A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary FibrosisIDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)Healthy Volunteers;Idiopathic Pulmonary FibrosisDrug: IDL-2965 Oral Capsule;Drug: PlacebosIndalo Therapeutics, Inc.NULLTerminated18 Years60 YearsAll6Phase 1United Kingdom
121EUCTR2018-004447-23-NL
(EUCTR)
16/04/201907/03/2019Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Cromolyn sodium [Disodium Cromoglycate]
Product Code: RVT-1601 (formerly, PA101B)
INN or Proposed INN: SODIUM CROMOGLICATE
Other descriptive name: SODIUM CROMOGLICATE
Respivant Sciences GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Germany;Netherlands;United Kingdom;Italy;New Zealand
122EUCTR2018-002664-73-ES
(EUCTR)
08/04/201912/04/2019Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Product Name: TD139
Product Code: TD139
INN or Proposed INN: TD139
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Ireland;Israel;Germany;Italy;United Kingdom
123EUCTR2018-001406-29-NL
(EUCTR)
03/04/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
124NCT03864328
(ClinicalTrials.gov)
March 29, 20192/3/2019A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPFRandomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC TrialPersistent Cough in IPF;Chronic Cough;IPFDrug: RVT-1601;Drug: PlaceboRespivant Sciences GmbHRespivant Sciences Inc.Terminated40 Years89 YearsAll108Phase 2United States;Australia;Belgium;Canada;Czechia;Germany;Italy;Netherlands;New Zealand;Turkey;United Kingdom
125EUCTR2018-001405-87-GB
(EUCTR)
29/03/201905/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
126EUCTR2018-001405-87-DE
(EUCTR)
21/03/201926/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
127EUCTR2017-004302-18-FI
(EUCTR)
05/03/201904/09/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
128EUCTR2018-001405-87-GR
(EUCTR)
21/02/201922/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
129NCT03832946
(ClinicalTrials.gov)
February 19, 20194/2/2019A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 WeeksIdiopathic Pulmonary Fibrosis (IPF)Drug: GB0139;Drug: PlaceboGalecto Biotech ABSyneos Health;bioRASI, LLCActive, not recruiting40 YearsN/AAll426Phase 2United States;Australia;Belgium;Canada;France;Georgia;Germany;Ireland;Israel;Italy;Poland;Spain;Ukraine;United Kingdom
130EUCTR2017-003158-18-PL
(EUCTR)
18/02/201930/11/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
131NCT03830125
(ClinicalTrials.gov)
February 13, 201931/1/2019Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy SubjectsA Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult SubjectsIdiopathic Pulmonary FibrosisDrug: BBT-877, Single dose;Drug: Placebo group;Drug: BBT-877, Multiple dosesBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll88Phase 1United States
132EUCTR2018-001406-29-FR
(EUCTR)
28/01/201929/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;South Africa;Germany;Netherlands;New Zealand;Korea, Republic of
133EUCTR2018-001405-87-CZ
(EUCTR)
23/01/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
134EUCTR2018-001406-29-HU
(EUCTR)
17/01/201904/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
135EUCTR2017-004302-18-HR
(EUCTR)
14/01/201916/05/2019A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
136EUCTR2018-001406-29-PL
(EUCTR)
21/12/201817/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
137EUCTR2018-001405-87-DK
(EUCTR)
20/12/201822/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Australia;Peru;Germany
138EUCTR2018-001406-29-IT
(EUCTR)
13/12/201820/01/2021A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis - - Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: [G451990]
Product Name: GLPG1690
Product Code: [G451990]
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of
139EUCTR2018-001405-87-ES
(EUCTR)
12/12/201818/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. Idiopatic pulmonary fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Australia;Denmark;Peru;Germany
140EUCTR2017-004302-18-SE
(EUCTR)
03/12/201801/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
141NCT03711162
(ClinicalTrials.gov)
November 28, 201815/10/2018A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLTerminated40 YearsN/AAll526Phase 3United States;Australia;Belgium;Brazil;Chile;Czechia;Denmark;Germany;Greece;Japan;Peru;Spain;Taiwan;Turkey;United Kingdom
142NCT03727802
(ClinicalTrials.gov)
November 28, 201824/10/2018Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary FibrosisTRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: TRK-250;Drug: PlaceboToray Industries, IncNULLCompleted40 Years80 YearsAll34Phase 1United States
143EUCTR2017-004919-39-DE
(EUCTR)
20/11/201816/07/2018A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ND-L02-s0201 for injection
INN or Proposed INN: TBC
Nitto Denko CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Germany;United Kingdom;Japan
144EUCTR2017-003158-18-DK
(EUCTR)
15/11/201816/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Korea, Republic of
145NCT03733444
(ClinicalTrials.gov)
November 5, 20185/11/2018A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLTerminated40 YearsN/AAll781Phase 3United States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;South Africa
146EUCTR2017-004302-18-BG
(EUCTR)
22/10/201806/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
147EUCTR2017-004302-18-FR
(EUCTR)
16/10/201803/08/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Egypt;France;Slovakia;Finland;Ukraine;Oman;Lebanon;Romania;Croatia;Bulgaria;Sweden
148EUCTR2017-003158-18-NL
(EUCTR)
10/10/201824/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
149NCT03725852
(ClinicalTrials.gov)
September 27, 20188/6/2018A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF)A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1205;Drug: PlaceboGalapagos NVNULLCompleted40 YearsN/AAll69Phase 2Bulgaria;Croatia;Finland;France;Oman;Romania;Slovakia;Sweden;Ukraine
150EUCTR2017-003158-18-BE
(EUCTR)
26/09/201829/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Korea, Republic of
151NCT03573505
(ClinicalTrials.gov)
September 24, 201819/6/2018An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BG00011;Drug: PlaceboBiogenNULLTerminated40 YearsN/AAll109Phase 2United States;Argentina;Australia;Belgium;Chile;Czechia;Denmark;France;Greece;Israel;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom
152EUCTR2017-003158-18-GR
(EUCTR)
21/09/201825/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
153EUCTR2017-002667-17-IT
(EUCTR)
20/09/201813/02/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis - Study of pharmacodynamics,pharmacokinetics, safety and tolerability of VAY736 in patients with idiop Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
154EUCTR2017-003158-18-GB
(EUCTR)
18/09/201810/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - 203PF203 mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
155EUCTR2017-003158-18-CZ
(EUCTR)
12/09/201809/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
156EUCTR2017-003158-18-IT
(EUCTR)
03/09/201805/11/2020Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: NA
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: [BG00011]
INN or Proposed INN: Not yet assigned
BIOGEN IDEC RESEARCH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Czechia;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of
157EUCTR2017-003158-18-ES
(EUCTR)
27/07/201805/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
158NCT03619616
(ClinicalTrials.gov)
July 16, 201823/7/2018Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy AdultsA Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy SubjectsIdiopathic Pulmonary Fibrosis(IPF);Solid TumorDrug: ZSP1603 7.5 mg;Drug: ZSP1603 12.5 mg;Drug: Placebo 12.5mg;Drug: ZSP1603 25 mg;Drug: Placebo 25mg;Drug: ZSP1603 50 mg;Drug: Placebo 50mgGuangdong Zhongsheng Pharmaceutical Co., Ltd.NULLCompleted18 Years50 YearsAll40Phase 1China
159EUCTR2017-004923-63-GB
(EUCTR)
10/07/201820/12/2017A study to test the safety, tolerability, and the effects of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: C21
INN or Proposed INN: PD00377 Na-salt
Other descriptive name: COMPOUND 21
Vicore Pharma ABNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Poland;Bulgaria;United Kingdom
160EUCTR2017-004302-18-SK
(EUCTR)
18/06/201804/05/2018A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF)A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1205
Product Code: G321605
INN or Proposed INN: NA
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
161NCT03538301
(ClinicalTrials.gov)
June 18, 20182/5/2018JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPFA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: ND-L02-s0201;Other: Other: PlaceboNitto Denko CorporationNULLCompleted40 Years80 YearsAll123Phase 2United States;Germany;Japan;United Kingdom
162EUCTR2017-002667-17-FR
(EUCTR)
06/06/201820/02/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
84 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Ireland;Germany;Italy;United Kingdom
163EUCTR2017-002667-17-DE
(EUCTR)
04/06/201823/01/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
164EUCTR2017-002667-17-GB
(EUCTR)
18/05/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;Italy;United Kingdom
165NCT03502902
(ClinicalTrials.gov)
April 26, 201810/4/2018The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female SubjectsA Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female SubjectsIdiopathic Pulmonary FibrosisDrug: HEC 68498;Drug: PlaceboSunshine Lake Pharma Co., Ltd.CovanceCompleted18 Years60 YearsAll55Phase 1United States
166EUCTR2017-002667-17-IE
(EUCTR)
06/04/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VAY736
INN or Proposed INN: not established
Other descriptive name: VAY736
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
167NCT03422068
(ClinicalTrials.gov)
March 16, 201822/1/2018This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.Idiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll15Phase 1Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France
168NCT02871401
(ClinicalTrials.gov)
January 3, 201815/8/2016A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Valganciclovir;Drug: PlaceboVanderbilt University Medical CenterGenentech, Inc.Completed21 Years80 YearsAll31Phase 1United States
169NCT03287414
(ClinicalTrials.gov)
December 20, 201712/9/2017Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary FibrosisA Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: VAY736;Drug: Placebo;Drug: Standard of Care (SoC)Novartis PharmaceuticalsNULLCompleted40 Years80 YearsAll30Phase 2United States;Canada;Germany;Ireland;Italy;United Kingdom;France
170EUCTR2016-003473-17-GB
(EUCTR)
14/09/201724/02/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA Phase 2, 24-Week Randomized, Double-blind, Placebo-ControlledMulticenter Study, With an 80-Week Active Treatment Extension, toEvaluate the Efficacy and Safety of CC-90001 in Subjects with IdiopathicPulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001
INN or Proposed INN: Not available
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2Colombia;Russian Federation;Romania;United States;United Kingdom;Greece;Canada;Turkey;Taiwan;Brazil;Australia;France;Germany
171NCT03142191
(ClinicalTrials.gov)
July 26, 201724/4/2017A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Fibrosis;Idiopathic Interstitial Pneumonias;Pathologic Processes;Lung Diseases, Interstitial;Lung Diseases;Respiratory Tract DiseasesDrug: CC-90001;Other: PlaceboCelgeneNULLCompleted40 YearsN/AAll138Phase 2United States;Australia;Brazil;Canada;Colombia;Germany;Greece;Romania;Russian Federation;Taiwan;Turkey;Ukraine;United Kingdom;China
172NCT03069989
(ClinicalTrials.gov)
June 13, 201728/2/2017Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) ImagingA Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) ImagingIdiopathic Pulmonary FibrosisDrug: GSK3008348;Drug: Placebo;Drug: [18F]-FBA-A20FMDV2GlaxoSmithKlineNULLTerminated50 YearsN/AAll8Phase 1United Kingdom
173NCT03092102
(ClinicalTrials.gov)
May 20, 201721/3/2017The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsA Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585Sunshine Lake Pharma Co., Ltd.NULLCompleted18 Years60 YearsAll136Phase 1United States
174EUCTR2016-003473-17-GR
(EUCTR)
05/05/201702/03/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis IDIOPATHIC PULMONARY FIBROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2United States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
175EUCTR2015-005131-40-CZ
(EUCTR)
20/03/201716/12/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
176EUCTR2015-005131-40-HU
(EUCTR)
16/01/201701/12/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany
177NCT02951429
(ClinicalTrials.gov)
December 31, 201628/10/2016Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary HypertensionA Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary HypertensionIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: Placebo;Drug: SildenafilHoffmann-La RocheNULLCompleted40 Years80 YearsAll177Phase 2Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates
178EUCTR2015-005131-40-BE
(EUCTR)
16/12/201620/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
179NCT02874989
(ClinicalTrials.gov)
December 16, 201617/8/2016Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human TrialTargeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Dasatinib + Quercetin;Drug: PlaceboWake Forest University Health SciencesMayo Clinic;The University of Texas Health Science Center at San AntonioCompleted50 YearsN/AAll26Phase 1United States
180EUCTR2015-005131-40-DE
(EUCTR)
08/12/201625/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
181EUCTR2015-005131-40-GR
(EUCTR)
06/12/201603/11/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
182EUCTR2015-005131-40-NL
(EUCTR)
02/12/201613/10/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
183EUCTR2015-005131-40-IT
(EUCTR)
09/11/201625/05/2021A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. - na Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: ESBRIET
Product Code: [RO0220912]
INN or Proposed INN: 00322900
Trade Name: Sildenafil
Product Name: sildenafil
Product Code: [G048E03]
INN or Proposed INN: 00258901
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Czechia;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
184EUCTR2015-003148-38-PL
(EUCTR)
08/11/201604/10/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
185EUCTR2015-005131-40-ES
(EUCTR)
20/10/201609/09/2016A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
186EUCTR2015-003148-38-DE
(EUCTR)
14/07/201620/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
187NCT02802345
(ClinicalTrials.gov)
June 30, 201614/6/2016Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function ImpairmentINSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function ImpairmentIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Placebo;Drug: SildenafilBoehringer IngelheimNULLCompleted40 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom
188EUCTR2015-003148-38-ES
(EUCTR)
13/06/201611/03/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
189NCT02788474
(ClinicalTrials.gov)
June 9, 201627/5/2016Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity ImpairmentA 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll347Phase 4United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic
190EUCTR2015-003148-38-BE
(EUCTR)
06/06/201619/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
191EUCTR2015-003148-38-GB
(EUCTR)
06/06/201618/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
192NCT02846324
(ClinicalTrials.gov)
June 20167/7/2016Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPFA Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;HypoxemiaDrug: GBT440;Drug: PlaceboGlobal Blood TherapeuticsNULLCompleted45 Years80 YearsAll39Phase 2United States
193EUCTR2015-003148-38-HU
(EUCTR)
27/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
194EUCTR2015-003148-38-CZ
(EUCTR)
26/05/201611/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States
195EUCTR2015-003148-38-FR
(EUCTR)
24/05/201604/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
196EUCTR2015-003148-38-FI
(EUCTR)
17/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
197EUCTR2015-004157-41-IT
(EUCTR)
13/05/201601/10/2021Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Stu Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
Other descriptive name: GLPG1690
GALAPAGOS NVNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom;Italy
198JPRN-JapicCTI-163326
01/5/201622/07/2016Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosisPhase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF)Intervention name : ART-123
INN of the intervention : thrombomodulin alfa
Dosage And administration of the intervention : 380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo by intravenous drip infusion in addition to standard of care steroid therapy
ASAHI KASEI PHARMA CORPORATIONNULLrecruiting4085BOTHPhase 3NULL
199NCT02739165
(ClinicalTrials.gov)
May 20161/4/2016Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary FibrosisPhase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123Idiopathic Pulmonary FibrosisDrug: ART-123;Drug: PlaceboAsahi Kasei Pharma CorporationNULLCompleted40 Years85 YearsAll74Phase 3Japan
200EUCTR2015-004157-41-GB
(EUCTR)
21/03/201602/12/2015Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: GLPG1690
Product Code: G451990
Other descriptive name: GLPG1690
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUkraine;United Kingdom
201NCT02503657
(ClinicalTrials.gov)
March 9, 201614/7/2015Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;IPFDrug: tipelukast;Drug: PlaceboMediciNovaNULLCompleted21 Years80 YearsAll15Phase 2United States
202NCT02738801
(ClinicalTrials.gov)
March 201611/4/2016Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: GLPG1690 600 mg QD;Drug: Placebo QDGalapagos NVNULLCompleted40 YearsN/AAll23Phase 2Ukraine;United Kingdom;Italy
203EUCTR2014-005658-20-BG
(EUCTR)
23/02/201618/12/2015FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;Level: HLT;Classification code 10033979;Term: Parenchymal lung disorders NEC;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: FG-3019 10mg/mL in 10 mL vials
Product Code: FG-3019
INN or Proposed INN: Pamrevlumab
FibroGen, Inc.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India
204EUCTR2014-003933-24-PT
(EUCTR)
15/02/201607/10/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
205NCT02612051
(ClinicalTrials.gov)
December 4, 201519/11/2015First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis PatientsA FTIH Study With GSK3008348 in Healthy Volunteers and Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GSK3008348 Nebuliser solution;Drug: Placebo Nebuliser solution;Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusionGlaxoSmithKlineNULLCompleted18 YearsN/AAll40Phase 1United Kingdom
206EUCTR2014-000861-32-DE
(EUCTR)
01/12/201502/09/2015Standard-armed controlled study to assess the impact of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)A randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial - RELIEF 1.Fibrotic NSIP., 2.Chronic Hypersensitivity Pneumonitis 3. Lung fibrosis associated with collagen / vascular diseases, 4.Asbestos-induced lung fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855
MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet® (Pirfenidon)
Product Name: Esbriet® (Pirfenidon)
Product Code: PZN 8881655(RochePharma AG)
INN or Proposed INN: PIRFENIDONE
Justus Liebig Universität GiessenNULLNot RecruitingFemale: yes
Male: yes
374Phase 2Germany
207NCT02550873
(ClinicalTrials.gov)
September 7, 201527/8/2015A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisBiological: PRM-151;Other: placeboHoffmann-La RocheNULLCompleted40 Years80 YearsAll117Phase 2United States;Czechia;Germany;Italy;Netherlands;Spain;Switzerland;Belgium;Czech Republic;Israel;United Kingdom
208EUCTR2014-003933-24-DE
(EUCTR)
31/08/201502/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
209NCT02502097
(ClinicalTrials.gov)
August 26, 201516/7/2015A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)A Randomized Placebo-Controlled Study to Assess the Efficacy and Safety of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF) With Persistent CoughIdiopathic Pulmonary Fibrosis;CoughDrug: Gefapixant;Other: PlaceboAfferent Pharmaceuticals, Inc.NULLCompleted40 YearsN/AAll51Phase 2United States
210EUCTR2014-003933-24-GB
(EUCTR)
29/07/201505/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
211EUCTR2014-003933-24-GR
(EUCTR)
14/05/201522/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
212EUCTR2014-003933-24-FR
(EUCTR)
12/05/201503/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
213EUCTR2014-003933-24-IT
(EUCTR)
06/05/201527/05/2021Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - DRI11772 Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SAR156597SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy
214NCT02345070
(ClinicalTrials.gov)
May 1, 201519/1/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging StudyIdiopathic Pulmonary FibrosisDrug: SAR156597;Drug: placeboSanofiNULLCompleted40 YearsN/AAll327Phase 2United States;Argentina;Australia;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Portugal;Spain;Turkey;United Kingdom;Czech Republic
215EUCTR2014-003933-24-ES
(EUCTR)
30/04/201503/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of;Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy
216EUCTR2014-003933-24-CZ
(EUCTR)
10/04/201513/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
217EUCTR2014-003933-24-DK
(EUCTR)
07/04/201520/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SAR156597
Product Code: SAR156597
INN or Proposed INN: SAR156597
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Australia;Germany;Korea, Republic of
218NCT02397005
(ClinicalTrials.gov)
March 201527/2/2015Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male SubjectsRandomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of ZL-2102 With a Pilot Investigation of Food Effect in Healthy Male SubjectsChronic Obstructive Pulmonary Disease;Asthma;Idiopathic Pulmonary FibrosisDrug: ZL-2102;Drug: Placebo matching ZL-2102Zai Lab Pty. Ltd.NULLActive, not recruiting18 Years45 YearsMale120Phase 1Australia
219NCT02412020
(ClinicalTrials.gov)
February 20153/4/2015Treatment of Refractory Chronic Cough With PA101Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101Refractory Chronic CoughDrug: PA101;Drug: PlaceboPatara PharmaNULLCompleted18 Years75 YearsBoth52Phase 2Netherlands;United Kingdom
220JPRN-JapicCTI-142708
24/10/201414/11/2014A phase II study of LebrikizumabA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY IDIOPATHIC PULMONARY FIBROSISIntervention name : RO5490255
INN of the intervention : Lebrikizumab
Dosage And administration of the intervention : 250mg SC injection every 4 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : SC injection every 4 weeks
Chugai Pharmaceutical Co., Ltd.NULL40BOTH480Phase 2NULL
221EUCTR2014-000963-42-DE
(EUCTR)
01/10/201413/08/2014A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosisA randomized, double-blind, placebo-controlled, phase II study to assess the efficacy and safety of oral vismodegib for the treatment of idiopathic pulmonary fibrosis - ISLAND Idiopathic pulmonary fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Erivedge
INN or Proposed INN: vismodegib
Other descriptive name: VISMODEGIB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Mexico;Spain;Peru;Australia;Israel;Chile;Germany;New Zealand;Italy;Korea, Republic of
222NCT02168530
(ClinicalTrials.gov)
October 201418/6/2014A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: placebo;Drug: vismodegibHoffmann-La RocheNULLWithdrawn40 YearsN/ABoth0Phase 2Australia;France;Germany;Israel;Korea, Republic of;Mexico;Peru;United States
223NCT02257177
(ClinicalTrials.gov)
September 201429/9/2014RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF PatientsA Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Inhaled TD139;Drug: PlaceboGalecto Biotech ABNULLCompleted45 Years85 YearsAll60Phase 1/Phase 2United Kingdom
224NCT02173145
(ClinicalTrials.gov)
August 19, 201423/6/2014Azithromycin in Idiopathic Pulmonary FibrosisAzithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical TrialIdiopathic Pulmonary Fibrosis;CoughDrug: azithromycin;Drug: placeboUniversity Hospital Inselspital, BerneUniversity of BernCompleted18 YearsN/AAll27N/ASwitzerland
225EUCTR2013-004404-19-GB
(EUCTR)
07/05/201425/03/2014Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosisA Randomized, Double-blind, Placebo-controlled, Crossover Study toAssess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis. - Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF Idiopathic pulmonary fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fostair
INN or Proposed INN: beclometasone dipropionate
INN or Proposed INN: formoterol fumarate dihydrate
Hull and East Yorkshire Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
226NCT02036970
(ClinicalTrials.gov)
May 201413/1/2014Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll166Phase 2United States;Germany;Spain;United Kingdom
227EUCTR2013-001163-24-BE
(EUCTR)
28/04/201410/02/2014A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
228NCT02085018
(ClinicalTrials.gov)
March 28, 20149/2/2014Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Omeprazole;Drug: Matched placeboNewcastle-upon-Tyne Hospitals NHS TrustNewcastle UniversityCompleted40 Years85 YearsAll45Phase 2United Kingdom
229NCT02048644
(ClinicalTrials.gov)
March 201423/1/2014Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: fostair;Drug: placeboHull University Teaching Hospitals NHS TrustChiesi Farmaceutici S.p.A.Completed40 Years85 YearsAll20Phase 2United Kingdom
230NCT02036580
(ClinicalTrials.gov)
January 201413/1/2014D2212C00002 J-Phase II StudyA Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: PlaceboAstraZenecaMedImmune LLCCompleted50 YearsN/AAll37Phase 2Japan
231NCT01969409
(ClinicalTrials.gov)
January 201417/10/2013Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary FibrosisAutoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)Ambulatory IPFDrug: Rituximab;Drug: PlaceboUniversity of Alabama at BirminghamNational Institutes of Health (NIH)Completed50 Years85 YearsAll58Phase 2United States
232NCT01979952
(ClinicalTrials.gov)
November 26, 20134/11/2013Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen MonthsIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: NintedanibBoehringer IngelheimNULLCompleted40 YearsN/AAll113Phase 3United States;Canada;Turkey
233NCT01777737
(ClinicalTrials.gov)
November 25, 201325/1/2013Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With CotrimoxazolePilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Cotrimoxazole;Drug: PlaceboFundación Pública Andaluza para la gestión de la Investigación en SevillaJunta de AndaluciaTerminated18 Years80 YearsAll3Phase 3Spain
234EUCTR2013-001163-24-IT
(EUCTR)
19/11/201305/09/2013A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
235NCT02013700
(ClinicalTrials.gov)
November 13, 20132/12/2013Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs);Biological: matched placeboJoshua M HareThe Lester And Sue Smith Foundation;The Emmes Company, LLCTerminated40 Years90 YearsAll9Phase 1United States
236EUCTR2013-001163-24-PL
(EUCTR)
09/11/201301/10/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
237EUCTR2013-001163-24-DE
(EUCTR)
04/11/201328/08/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
238EUCTR2013-001163-24-GB
(EUCTR)
14/10/201306/11/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Trade Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
239NCT01872689
(ClinicalTrials.gov)
October 13, 20135/6/2013A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Lebrikizumab;Drug: Pirfenidone;Drug: PlaceboHoffmann-La RocheNULLCompleted40 YearsN/AAll505Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Mexico;Peru;Poland;Spain;United Kingdom
240EUCTR2013-001163-24-ES
(EUCTR)
20/09/201316/09/2013A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Peru;Australia;Germany;Japan
241EUCTR2013-003301-26-GB
(EUCTR)
20/09/201304/11/2013A clinical trial to assess whether a treatment reducing acid production in the stomach (omeprazole) can reduce cough in patients with scarring of the lungs.A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF) - Pilot trial of omeprazole in idiopathic pulmonary fibrosis (Acronym : Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Omeprazole (UK licensed generic product)
Product Name: Omeprazole
INN or Proposed INN: Omeprazole
Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
242EUCTR2013-001163-24-FR
(EUCTR)
17/09/201328/09/2015A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis.A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lebrikizumab
Product Code: RO5490255/F01-02
INN or Proposed INN: LEBRIKIZUMAB
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
243EUCTR2012-000564-14-GB
(EUCTR)
11/09/201304/07/2013 A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
244EUCTR2012-001571-36-PL
(EUCTR)
09/09/201317/06/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
245EUCTR2012-000564-14-DK
(EUCTR)
28/08/201312/07/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
246NCT02707640
(ClinicalTrials.gov)
August 20139/3/2016A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of PirfenidoneIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: N-acetylcysteine;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll123Phase 2Austria;Belgium;Denmark;France;Germany;Italy;Sweden;United Kingdom
247NCT01890265
(ClinicalTrials.gov)
July 30, 201324/6/2013Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: NintedanibFibroGenNULLCompleted40 Years80 YearsAll160Phase 2United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa
248EUCTR2012-000564-14-AT
(EUCTR)
19/07/201311/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
249EUCTR2012-000564-14-DE
(EUCTR)
17/07/201329/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
250EUCTR2012-000564-14-IT
(EUCTR)
17/07/201307/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
251EUCTR2012-000564-14-SE
(EUCTR)
25/06/201324/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
252EUCTR2012-000564-14-BE
(EUCTR)
18/06/201330/04/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of PirfenidoneA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA Patients with Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
253EUCTR2012-001571-36-DE
(EUCTR)
17/06/201302/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
254EUCTR2012-001571-36-BE
(EUCTR)
28/05/201326/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain
255EUCTR2012-001571-36-ES
(EUCTR)
12/05/201316/05/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER Idiopathic pulmonary fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
256EUCTR2012-001571-36-CZ
(EUCTR)
29/04/201315/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
257EUCTR2012-001571-36-IT
(EUCTR)
26/04/201328/02/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
258EUCTR2012-001571-36-GB
(EUCTR)
19/04/201328/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER Idiopathic pulmonary fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of
259EUCTR2012-005794-31-GB
(EUCTR)
25/03/201326/02/2013A study to assess the effect of a single-does of VRP700 by inhalation to reduce the frequency and severity of cough in adults with Idiopathic Pulmonary Fibrosis (IPF)A randomised, double-blind, placebo-controlled crossover study to assess the efficacy of a single dose of 100mg of VRP700 by inhalation in reducing the frequency and severity of cough in adult patients with Idiopathic Pulmonary Fibrosis - EPOCh Chronic cough in Idiopathic Pulmonary Fibrosis
MedDRA version: 16.1;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.1;Level: PT;Classification code 10011224;Term: Cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VRP700
Product Code: VRP700
Verona Pharma plcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
260NCT01725139
(ClinicalTrials.gov)
March 8, 20138/11/2012A Proof of Mechanism Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: GSK2126458;Drug: PlaceboGlaxoSmithKlineNULLCompleted45 YearsN/AAll17Phase 1United Kingdom
261NCT02594839
(ClinicalTrials.gov)
February 20131/11/2015Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseA Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseIdiopathic Interstitial Pneumonia;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: Bone marrow mesenchymal stem cells;Drug: PlaceboFederal Research Clinical Center of Federal Medical & Biological Agency, RussiaNULLCompleted20 Years80 YearsAll20Phase 1/Phase 2Russian Federation
262NCT01769196
(ClinicalTrials.gov)
January 31, 201314/1/2013Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Simtuzumab;Drug: Simtuzumab placeboGilead SciencesNULLTerminated45 Years85 YearsAll544Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic
263NCT01766817
(ClinicalTrials.gov)
January 31, 201310/1/2013Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisSafety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BMS-986020;Drug: Placebo matching with BMS-986020Bristol-Myers SquibbNULLCompleted40 Years90 YearsAll325Phase 2United States;Australia;Chile;Colombia;Mexico;Peru
264NCT01629667
(ClinicalTrials.gov)
October 201212/6/2012A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisA Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: Tralokinumab;Other: PlaceboMedImmune LLCNULLTerminated50 Years79 YearsAll409Phase 2United States;Australia;Canada;Israel;Korea, Republic of;Peru
265NCT01371305
(ClinicalTrials.gov)
July 16, 20123/6/2011STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)Drug: BG00011;Drug: PlaceboBiogenNULLCompleted18 Years84 YearsAll41Phase 2United States
266NCT01529853
(ClinicalTrials.gov)
April 20126/2/2012To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: SAR156597;Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth24Phase 1/Phase 2United States;Canada;Chile;Mexico;Spain;Belgium
267NCT01504334
(ClinicalTrials.gov)
January 201230/12/2011Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboBeijing Kawin Technology Share-Holding Co., Ltd.NULLRecruiting18 Years75 YearsBoth80Phase 2China
268NCT02136992
(ClinicalTrials.gov)
December 201111/5/2014Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: placeboShanghai Pulmonary Hospital, Shanghai, ChinaNanjing Chia-tai Tianqing PharmaceuticalCompletedN/A75 YearsBoth160Phase 2NULL
269NCT01462006
(ClinicalTrials.gov)
October 201126/10/2011Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)Double-blind Placebo-controlled Pilot Study of Sirolimus in IPFIdiopathic Pulmonary Fibrosis;Diffuse Parenchymal Lung Disease;Interstitial Lung DiseaseDrug: sirolimus;Other: PlaceboUniversity of VirginiaNational Heart, Lung, and Blood Institute (NHLBI)Completed21 Years85 YearsAll32N/AUnited States
270EUCTR2010-020688-18-GB
(EUCTR)
29/06/201128/01/2011Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF)A randomized, double-blind, placebo-controlled, multipledose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics andpharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis Patients with rapidly progressive idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Code: QAX576Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
271EUCTR2010-024252-29-NL
(EUCTR)
16/06/201111/05/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Germany;Netherlands
272NCT01366209
(ClinicalTrials.gov)
June 20112/6/2011Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)Idiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll555Phase 3United States
273EUCTR2010-024252-29-ES
(EUCTR)
25/05/201103/11/2011-A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Portugal;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Germany;Netherlands;China;Japan;Korea, Republic of
274EUCTR2010-024251-87-BE
(EUCTR)
18/05/201117/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
275EUCTR2010-024252-29-PT
(EUCTR)
13/05/201116/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
485China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands
276EUCTR2010-024251-87-IE
(EUCTR)
11/05/201123/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
277EUCTR2010-024251-87-IT
(EUCTR)
10/05/201119/09/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
646Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy
278EUCTR2010-024252-29-GR
(EUCTR)
02/05/201104/04/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
279NCT01335477
(ClinicalTrials.gov)
May 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients IIA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll551Phase 3United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey
280EUCTR2010-024251-87-GB
(EUCTR)
28/04/201124/02/2011Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Phase 3Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
281EUCTR2010-024251-87-CZ
(EUCTR)
26/04/201108/04/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
485India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom
282EUCTR2010-024251-87-DE
(EUCTR)
12/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
283EUCTR2010-024252-29-DE
(EUCTR)
07/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of
284EUCTR2010-024252-29-FI
(EUCTR)
01/04/201104/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
285NCT01335464
(ClinicalTrials.gov)
April 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis PatientsA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll515Phase 3United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil
286EUCTR2009-011169-98-CZ
(EUCTR)
10/01/201129/11/2010ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.1;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United Kingdom;Germany;Czech Republic;Italy;Austria
287NCT01203943
(ClinicalTrials.gov)
January 1, 201115/9/2010A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis;Fibrosis;Interstitial Lung Disease;Lung Diseases, InterstitialDrug: CC-930;Other: PlaceboCelgeneNULLTerminated50 YearsN/AAll28Phase 2United States;Canada
288NCT01254409
(ClinicalTrials.gov)
January 20113/12/2010A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: PRM-151;Other: PlaceboHoffmann-La RocheNULLCompleted40 Years80 YearsAll21Phase 1United States;Netherlands
289NCT01266135
(ClinicalTrials.gov)
December 201017/12/2010Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPFIdiopathic Pulmonary FibrosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years80 YearsAll40Phase 2United States;United Kingdom
290EUCTR2008-004405-34-CZ
(EUCTR)
13/09/201007/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
291EUCTR2008-001281-86-DE
(EUCTR)
02/08/201016/03/2010A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary FibrosisA Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Netherlands;Belgium
292NCT01136174
(ClinicalTrials.gov)
May 201031/5/2010Safety and PK Study of BIBF 1120 in Japanese Patients With IPFA Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.Idiopathic Pulmonary FibrosisDrug: Placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll50Phase 2Japan
293EUCTR2008-006054-17-IT
(EUCTR)
26/01/201022/10/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharamceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
294EUCTR2009-011169-98-AT
(EUCTR)
26/11/200925/08/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
295EUCTR2009-011169-98-DE
(EUCTR)
03/11/200906/08/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
296EUCTR2009-011169-98-GB
(EUCTR)
30/10/200901/09/2009ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PHARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;Germany;United Kingdom;Italy;Austria
297NCT00957242
(ClinicalTrials.gov)
October 200910/8/2009AntiCoagulant Effectiveness in Idiopathic Pulmonary FibrosisAntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)Idiopathic Pulmonary FibrosisDrug: warfarin;Drug: placeboDuke UniversityNational Heart, Lung, and Blood Institute (NHLBI);Duke Clinical Research InstituteTerminated35 Years80 YearsAll145Phase 3United States
298EUCTR2009-011169-98-IT
(EUCTR)
22/09/200921/09/2009A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - NDA Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10021240
MedDRA version: 9.1;Classification code 10037400
Trade Name: Letairis
Trade Name: Letairis
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
299EUCTR2008-004405-34-IE
(EUCTR)
08/09/200907/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMISA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
300NCT00981747
(ClinicalTrials.gov)
September 200919/9/2009Targeting Vascular Reactivity in Idiopathic Pulmonary FibrosisA Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Pulmonary FibrosisDrug: Sildenafil;Drug: Losartan;Drug: Sildenafil and Losartan;Drug: Placebo Oral TabletAlicia GerkePulmonary Fibrosis FoundationTerminated18 Years99 YearsAll12Phase 2/Phase 3United States
301EUCTR2008-006054-17-SE
(EUCTR)
12/08/200925/06/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
302EUCTR2008-004405-34-IT
(EUCTR)
03/08/200927/07/2009A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
303NCT00879229
(ClinicalTrials.gov)
July 20098/4/2009ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary FibrosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary HypertensionIdiopathic Pulmonary Fibrosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboGilead SciencesNULLTerminated35 Years80 YearsAll40Phase 3United States;Australia;Austria;Canada;Germany;Italy;United Kingdom;Belgium;Ireland;Israel
304EUCTR2008-004405-34-GB
(EUCTR)
08/06/200928/04/2009ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
305EUCTR2008-004405-34-NL
(EUCTR)
04/06/200910/03/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;Czech Republic;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
306EUCTR2008-006054-17-ES
(EUCTR)
20/05/200901/04/2009Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSICEstudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC Evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2France;Slovenia;Spain;Germany;Italy;Sweden
307NCT00903331
(ClinicalTrials.gov)
May 200914/5/2009Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical StudyA Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: ACT-064992 (macitentan);Drug: PlaceboActelionNULLCompleted18 YearsN/AAll178Phase 2United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey
308EUCTR2008-006054-17-FR
(EUCTR)
29/04/200925/03/2009MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSICMUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosisProduct Name: ACT-064992
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2France;Slovenia;Spain;Germany;Italy;Sweden
309EUCTR2008-001281-86-BE
(EUCTR)
24/04/200915/10/2008A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary FibrosisA Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Germany;Netherlands
310EUCTR2008-006054-17-SI
(EUCTR)
31/03/200906/04/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
311EUCTR2008-004405-34-ES
(EUCTR)
27/03/200928/01/2009ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMISARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS Idiopathic Pulmonary Fibrosis (IPF)fibrosis pulmonar idiopática temprana (FPI)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
312EUCTR2008-004405-34-AT
(EUCTR)
13/03/200921/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMISA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
313EUCTR2008-004405-34-BE
(EUCTR)
09/03/200922/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
314EUCTR2008-004405-34-FR
(EUCTR)
09/02/200916/03/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMISA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
315EUCTR2008-001281-86-NL
(EUCTR)
14/01/200925/09/2008A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary FibrosisA Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Netherlands;Belgium
316NCT00768300
(ClinicalTrials.gov)
December 20087/10/2008(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPFARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Ambrisentan;Drug: PlaceboGilead SciencesNULLTerminated40 Years80 YearsAll494Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;France;Germany;Ireland;Israel;Italy;Mexico;Netherlands;Peru;Poland;Spain;Switzerland;United Kingdom
317NCT00786201
(ClinicalTrials.gov)
December 20084/11/2008A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: Placebo;Drug: CNTO 888 1 mg/kg;Drug: CNTO 888 5 mg/kg;Drug: CNTO 888 15 mg/kgCentocor, Inc.NULLCompleted40 Years80 YearsBoth126Phase 2United States;Belgium;Canada;Germany;Netherlands
318NCT00690885
(ClinicalTrials.gov)
June 20083/6/2008Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary FibrosisEvaluation of Natural Human Interferon Alpha Lozenges in the Treatment of Chronic Cough in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF)Pulmonary Disease, Chronic Obstructive;Pulmonary Fibrosis;CoughDrug: interferon-alpha lozenges;Drug: placebo lozengesAmarillo Biosciences, Inc.Texas Tech University Health Sciences CenterTerminated40 YearsN/ABoth1Phase 2United States
319EUCTR2006-002875-42-BG
(EUCTR)
12/05/200809/05/2008A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;France;Bulgaria;Spain;Ireland;Italy;Greece
320NCT00637065
(ClinicalTrials.gov)
April 200810/3/2008Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment StudyUse of the Endothelin-1 Antagonist Bosentan in Patients With Established Pulmonary Hypertension and Fibrotic Lung Disease. - A Randomised, Placebo-Controlled, Double-Blinded Study.Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Nonspecific Interstitial PneumoniaDrug: Bosentan;Drug: PlaceboRoyal Brompton & Harefield NHS Foundation TrustActelionNot yet recruiting18 Years80 YearsBoth48Phase 4United Kingdom
321EUCTR2006-002875-42-GR
(EUCTR)
22/01/200820/09/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
322EUCTR2006-002875-42-PT
(EUCTR)
11/01/200812/09/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
323EUCTR2006-002875-42-CZ
(EUCTR)
19/12/200710/07/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany;Netherlands
324EUCTR2007-001645-17-GB
(EUCTR)
04/12/200710/10/2007Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung DiseasePrevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: Tracleer
Royal Brompton and Harefield NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
325NCT00600028
(ClinicalTrials.gov)
December 200711/1/2008Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With ThalidomideTreatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With ThalidomideIdiopathic Pulmonary Fibrosis;CoughDrug: Thalidomide;Drug: PlaceboJohns Hopkins UniversityNULLCompleted50 YearsN/AAll25Phase 3United States
326EUCTR2006-002875-42-GB
(EUCTR)
20/11/200714/10/2010A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Greece;Spain;Ireland;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
327EUCTR2006-002875-42-HU
(EUCTR)
26/09/200727/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV Ges mbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
328EUCTR2006-002875-42-IE
(EUCTR)
11/09/200712/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
329EUCTR2006-002875-42-FR
(EUCTR)
23/08/200726/07/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim France SASNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
330EUCTR2006-002875-42-ES
(EUCTR)
20/08/200719/06/2007Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. Fibrosis pulmonar idiopática
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece
331EUCTR2006-002875-42-BE
(EUCTR)
14/08/200724/05/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
332NCT00517933
(ClinicalTrials.gov)
August 200715/8/2007Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary FibrosisSildenafil Trial of Exercise Performance in Idiopathic Pulmonary FibrosisPulmonary Fibrosis;Hypertension, PulmonaryDrug: Sildenafil Citrate;Other: PlaceboDuke UniversityNational Heart, Lung, and Blood Institute (NHLBI);PfizerCompleted18 YearsN/AAll180Phase 3United States
333NCT00514683
(ClinicalTrials.gov)
August 20079/8/2007Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary FibrosisA 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.Pulmonary FibrosisDrug: low dose BIBF1120 once daily;Drug: low dose BIBF 1120 twice daily;Drug: intermediate dose BIBF 1120 twice daily;Drug: high dose BIBF 1120 twice daily;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll432Phase 2Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czech Republic;France;Germany;Greece;Hungary;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;South Africa;Spain;Taiwan;Turkey;United Kingdom;El Salvador
334EUCTR2004-001876-37-DE
(EUCTR)
27/07/200727/02/2007BENEFIT-study: A randomized placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody ( infliximab) in idiopathic pulmonary fibrosis. - BENEFITBENEFIT-study: A randomized placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody ( infliximab) in idiopathic pulmonary fibrosis. - BENEFIT Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Remicade
Product Name: Remicade
Academic Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Germany
335EUCTR2006-002875-42-IT
(EUCTR)
17/07/200709/08/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. idiopathic pulmonary fibrosis (IPF)
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: NA
Product Code: BIBF 1120 ES
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy
336EUCTR2006-002875-42-NL
(EUCTR)
16/07/200704/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
337EUCTR2006-002875-42-DE
(EUCTR)
06/07/200708/05/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy
338EUCTR2006-001183-24-IE
(EUCTR)
30/04/200716/11/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
339EUCTR2006-001183-24-GB
(EUCTR)
09/03/200723/11/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
340EUCTR2006-001183-24-NL
(EUCTR)
06/03/200710/11/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
341EUCTR2006-001183-24-SK
(EUCTR)
26/02/200719/01/2007Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
342EUCTR2006-001183-24-DE
(EUCTR)
22/02/200701/12/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom
343EUCTR2006-001183-24-ES
(EUCTR)
14/02/200707/04/2010Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Spanish:Fibrosis Pulmonar IdiopáticaEnglish:Idiopathic Pulmonary Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Slovakia;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
344EUCTR2006-001183-24-CZ
(EUCTR)
07/02/200721/12/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
345NCT00625079
(ClinicalTrials.gov)
February 200719/2/2008Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerWithdrawnN/AN/AAll0Phase 4United States
346NCT00391443
(ClinicalTrials.gov)
February 200720/10/2006BUILD 3: Bosentan Use in Interstitial Lung DiseaseEffects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.Idiopathic Pulmonary FibrosisDrug: Bosentan;Drug: PlaceboActelionNULLCompleted18 YearsN/AAll616Phase 3United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Netherlands;Serbia;Spain;Switzerland;United Kingdom;Denmark;Former Serbia and Montenegro;Slovakia
347EUCTR2006-001183-24-DK
(EUCTR)
24/01/200712/12/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Spain;Ireland;Italy;Austria
348EUCTR2006-001183-24-AT
(EUCTR)
10/01/200711/12/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
349EUCTR2006-001183-24-BE
(EUCTR)
12/12/200614/11/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
460Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
350EUCTR2006-001183-24-IT
(EUCTR)
11/12/200605/01/2007Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3 Patients with Idiopathic pulmonary fibrosis
Level: PTClassification code 10037383
Trade Name: TRACLEERActelion Pharmaceuticals LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
351EUCTR2006-000252-41-IT
(EUCTR)
27/09/200630/08/2006A randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirferidone in patients with Idiopathic Pulmonary Fibrosis - NDA randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirferidone in patients with Idiopathic Pulmonary Fibrosis - ND Idiopathic pulmonary fibrosis IPF ICD X J84.1other interstitial pulmonary
MedDRA version: 6.1;Level: PT;Classification code 10037383
Product Name: PIR, S-7701INTERMUNENULLNot RecruitingFemale: yes
Male: yes
325Phase 3United Kingdom;Italy
352EUCTR2006-000138-11-ES
(EUCTR)
31/07/200618/05/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopáticaA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopática Idiopathic Pulmonary Fibrosis (IPF)Fibrosis Pulmonar IdiopáticaProduct Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Belgium;Spain;Ireland;Germany
353NCT00287716
(ClinicalTrials.gov)
July 14, 20066/2/2006Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll435Phase 3United States
354EUCTR2006-000138-11-DE
(EUCTR)
29/06/200616/02/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Germany;Belgium;Spain;Ireland
355EUCTR2006-000252-41-GB
(EUCTR)
29/06/200611/04/2006A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot Recruiting Female: yes
Male: yes
325 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly;United Kingdom
356EUCTR2006-000138-11-BE
(EUCTR)
27/06/200610/03/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Germany;Belgium;Spain;Ireland
357EUCTR2006-000138-11-CZ
(EUCTR)
25/05/200606/04/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Germany;Czech Republic;Belgium;Spain;Ireland
358NCT00287729
(ClinicalTrials.gov)
April 20066/2/2006Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll344Phase 3United States
359NCT00518310
(ClinicalTrials.gov)
May 200516/8/2007Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary FibrosisAzathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis: a Randomized, Double-Blind, Controlled StudyIdiopathic Pulmonary FibrosisDrug: Placebo;Drug: AZAPREDThorax National InstituteSociedad Chilena de Enfermedades Respiratorias;Servicio de Salud Metropolitano Oriente, Ministerio de Salud de ChileRecruiting45 Years79 YearsBoth100N/AChile
360NCT00109681
(ClinicalTrials.gov)
April 20052/5/2005Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary Fibrosis;Pulmonary HypertensionDrug: Iloprost Inhalation Solution (Ventavis)ActelionNULLCompleted40 Years85 YearsBoth50Phase 2United States
361EUCTR2004-000029-31-IE
(EUCTR)
28/01/200508/12/2004A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-Ib in patients with Idiopathic Pulmonary Fibrosis The INSPIRE Trial - International Study of Survival outcomes in IPF with Interferon gamma-1b) - INSPIREA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-Ib in patients with Idiopathic Pulmonary Fibrosis The INSPIRE Trial - International Study of Survival outcomes in IPF with Interferon gamma-1b) - INSPIRE Idiopathic Pulmonary Fibrosis (IPF)Trade Name: Immukin
Product Name: Interferon gamma-1b
InterMuneNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Ireland
362NCT00105183
(ClinicalTrials.gov)
January 20058/3/2005EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft RejectionA Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of an Anti-human-T-lymphocyte Immune Globulin (EZ-2053) in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s)Chronic Obstructive Pulmonary;Idiopathic Pulmonary Fibrosis;Cystic Fibrosis;Bronchiectasis;Pulmonary Vascular DiseaseBiological: Placebo;Biological: EZ-2053;Biological: EZ-2053 5mg/kgNeovii BiotechNULLCompleted18 YearsN/AAll223Phase 3United States;Australia;Austria;Canada
363NCT00075998
(ClinicalTrials.gov)
December 200312/1/2004The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)Idiopathic Pulmonary Fibrosis;Lung Disease;Pulmonary FibrosisDrug: Interferon gamma-1b (Actimmune)InterMuneNULLTerminated40 Years79 YearsBoth826Phase 3United States
364NCT00071461
(ClinicalTrials.gov)
August 200323/10/2003Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary FibrosisA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label ExtensionIdiopathic Pulmonary FibrosisDrug: bosentan;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth158Phase 2/Phase 3United States;Canada;France;Germany;Israel;Italy;Switzerland;United Kingdom
365NCT00063869
(ClinicalTrials.gov)
July 20037/7/2003Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary FibrosisA Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.Pulmonary FibrosisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted40 Years80 YearsBoth88Phase 2United States
366NCT00131274
(ClinicalTrials.gov)
April 200317/8/2005Gleevec Idiopathic Pulmonary Fibrosis (IPF) StudyA Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Lung Disease;Pulmonary FibrosisDrug: Imatinib Mesylate (Gleevec)Daniels, Craig E., M.D.NovartisCompleted20 Years79 YearsBoth120Phase 2/Phase 3NULL
367NCT00047658
(ClinicalTrials.gov)
November 20019/10/2002A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label ExtensionIdiopathic Pulmonary FibrosisDrug: Interferon-gamma 1bInterMuneNULLCompleted20 Years79 YearsBoth32Phase 2United States
368NCT00047645
(ClinicalTrials.gov)
April 20009/10/2002A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Interferon-gamma 1bInterMuneNULLCompleted20 Years79 YearsBoth330Phase 3United States
369NCT00639496
(ClinicalTrials.gov)
March 200013/3/2008Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: n-acetylcysteine;Drug: placeboZambon SpANULLCompleted18 Years75 YearsBoth184Phase 3Belgium;France;Germany;Italy;Netherlands;Spain;United Kingdom
370EUCTR2008-006054-17-DE
(EUCTR)
05/03/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156France;Slovenia;Spain;Germany;Italy;Sweden
371EUCTR2006-001183-24-FR
(EUCTR)
28/11/2006Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Tracleer
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
Trade Name: Tracleer
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ACTELION PHARMACEUTICALS LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
372EUCTR2008-004405-34-DE
(EUCTR)
14/01/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Trade Name: Letairis 5 mg
INN or Proposed INN: Ambrisentan
Trade Name: Letairis 10 mg
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom