51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
240 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04647890
(ClinicalTrials.gov)
February 202116/11/2020Effects of FT011 in Systemic SclerosisA Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic SclerosisScleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, SystemicDrug: FT011;Drug: PlaceboCerta TherapeuticsNULLNot yet recruiting18 Years75 YearsAll30Phase 2NULL
2NCT04515706
(ClinicalTrials.gov)
January 1, 202113/8/2020Iguratimod in Systemic SclerosisSafety, Tolerability, Efficacy of Iguratimod in Systemic SclerosisSystemic Sclerosis, DiffuseDrug: Iguratimod;Drug: PlaceboRenJi HospitalNULLNot yet recruiting19 Years74 YearsAll20N/ANULL
3NCT04440592
(ClinicalTrials.gov)
December 31, 202017/6/2020Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: MT-7117;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 Years75 YearsAll72Phase 2United States
4EUCTR2020-000134-17-GB
(EUCTR)
23/12/202005/08/2020A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Dersimelagon
Product Code: MT-7117
INN or Proposed INN: Dersimelagon
Other descriptive name: MT-7117
Mitsubishi Tanabe Pharma Development America (MTDA), Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom
5EUCTR2020-002081-13-NL
(EUCTR)
02/11/202017/08/2020A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248
Gesynta Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04478994
(ClinicalTrials.gov)
November 202016/7/2020A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: TEPEZZA;Other: PlaceboHorizon Therapeutics USA, Inc.NULLRecruiting18 Years80 YearsAll25Phase 1United States
7NCT04356287
(ClinicalTrials.gov)
October 202015/4/2020Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic SclerosisPhase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic SclerosisSclerosis, Systemic;Mesenchymal Stem CellsBiological: UCMSC;Other: PlaceboMarie Hudson, MDAssistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health CentreNot yet recruiting18 YearsN/AAll18Phase 1/Phase 2NULL
8NCT04300426
(ClinicalTrials.gov)
September 24, 202025/2/2020Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week StudySystemic SclerosisDrug: ACHIM as solute (10^9 intestinal microbes/ml)Oslo University HospitalSouth-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years85 YearsAll70Phase 2Norway
9NCT04356755
(ClinicalTrials.gov)
September 22, 202011/3/2020Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With SclerodermaSystemic SclerosisProcedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll32Phase 2France
10EUCTR2020-002081-13-GB
(EUCTR)
08/09/202021/07/2020A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248
Gesynta Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000906-31-DE
(EUCTR)
01/07/202031/10/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
12NCT04166552
(ClinicalTrials.gov)
June 11, 20206/11/2019Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic SclerosisA Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Patients will be randomized to receive EHP-101 or PlaceboEmerald Health Pharmaceuticals Inc.Iqvia Pty LtdRecruiting18 Years70 YearsAll36Phase 2United States;Australia;New Zealand
13EUCTR2019-000906-31-GB
(EUCTR)
22/05/202029/10/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
14NCT04200755
(ClinicalTrials.gov)
May 19, 202010/12/2019Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized SclerodermaA Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized SclerodermaLocalized SclerodermaDrug: Dupilumab 300Mg Solution for Injection;Other: PlaceboUniversity of CologneNULLRecruiting18 YearsN/AAll45Phase 2Germany
15EUCTR2019-000906-31-PL
(EUCTR)
31/01/202006/12/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04388176
(ClinicalTrials.gov)
January 3, 202011/5/2020Cold Challenge With C21 in RPA Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)Raynaud Phenomenon;Systemic SclerosisDrug: C21;Drug: PlaceboVicore Pharma ABSGS Life Sciences, a division of SGS Belgium NVRecruiting19 Years75 YearsAll16Phase 2United Kingdom
17NCT04138485
(ClinicalTrials.gov)
December 20, 201914/10/2019Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: IgPro10;Biological: PlaceboCSL BehringNULLWithdrawn18 YearsN/AAll0Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
18EUCTR2019-000906-31-ES
(EUCTR)
16/12/201920/12/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
19EUCTR2019-003203-35-GB
(EUCTR)
13/12/201905/09/2019NAA Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc) Systemic sclerosis (SSc)Raynaud’s phenomenon (RP)
MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: NA
Product Code: C21
INN or Proposed INN: NA
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt
Vicore Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United Kingdom
20EUCTR2019-000906-31-FR
(EUCTR)
03/12/201908/11/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-002036-90-DE
(EUCTR)
02/12/201902/10/2019Study to test effectiveness and safety of the drug Dupilumab in patients with localized sclerodermaA randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph Localized scleroderma
MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Dupilumab
Product Code: Dupilumab
INN or Proposed INN: Dupilumab
Other descriptive name: SAR231893
University of CologneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Germany
22NCT04040322
(ClinicalTrials.gov)
October 14, 201930/7/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLRecruiting18 YearsN/AAll180Phase 3United States
23NCT03844061
(ClinicalTrials.gov)
July 29, 201931/1/2019Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMFHospital for Special Surgery, New YorkGlaxoSmithKlineRecruiting18 Years80 YearsAll30Phase 2United States
24NCT04045743
(ClinicalTrials.gov)
July 19, 201927/7/2019The Benefit of Bermekimab in Patients With Systemic SclerosisClinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)Scleroderma, SystemicDrug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)Hellenic Institute for the Study of SepsisNULLRecruiting18 YearsN/AAll20Phase 2Greece
25EUCTR2015-004613-24-BE
(EUCTR)
17/07/201918/04/2019Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solu-Medrol
Product Name: methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Belgium;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03919799
(ClinicalTrials.gov)
July 9, 201921/11/2018KD025 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic SclerosisSystem; Sclerosis;Diffuse Cutaneous Systemic SclerosisDrug: Belumosudil (KD025);Drug: PlaceboKadmon Corporation, LLCNULLRecruiting18 Years100 YearsAll60Phase 2United States
27NCT04036227
(ClinicalTrials.gov)
July 3, 201923/7/2019Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)HealthyDrug: GS-248;Drug: PlaceboGesynta Pharma ABCTC Clinical Trial ConsultantsCompleted18 Years75 YearsAll72Phase 1Sweden
28JPRN-JapicCTI-194761
23/5/201917/05/2019A Phase 3 study of KHK4827 in patients with systemic sclerosisA Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening Systemic sclerosisIntervention name : KHK4827
INN of the intervention : Brodalumab
Dosage And administration of the intervention : 210 mg Q2W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 210 mg Q2W, SC
Kyowa Kirin Co., Ltd.NULLcomplete1870BOTH100Phase 3Japan
29NCT03957681
(ClinicalTrials.gov)
May 23, 201916/5/2019A Phase 3 Study of KHK4827 in Patients With Systemic SclerosisA Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin ThickeningModerate to Severe Systemic SclerosisDrug: KHK4827;Drug: PlaceboKyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll100Phase 3Japan
30EUCTR2018-001817-33-BE
(EUCTR)
05/04/201923/01/2019A clinical study to test how effective and safe GLPG1690 is for patients with Systemic SclerosisA Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-001817-33-DE
(EUCTR)
29/03/201923/01/2019A clinical study to test how effective and safe GLPG1690 is for patients with Systemic SclerosisA Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Belgium;Spain;Germany;Italy;United Kingdom
32NCT03867097
(ClinicalTrials.gov)
March 4, 20196/3/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLCompleted18 YearsN/AAll41Phase 2United States
33EUCTR2018-001817-33-GB
(EUCTR)
14/01/201920/11/2018A clinical study to test how effective and safe GLPG1690 is for patients with Systemic SclerosisA Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;Italy;United Kingdom
34NCT03798366
(ClinicalTrials.gov)
January 14, 20193/1/2019A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic SclerosisA Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic SclerosisSclerodermaDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll33Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
35NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03211793
(ClinicalTrials.gov)
November 201827/4/2017Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic SclerosisMesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS TrialSystemic Sclerosis;Digital UlcerDrug: Mesenchymal stromal cells;Other: PlaceboUMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown status18 YearsN/AAll20Phase 1/Phase 2Netherlands
37NCT03717961
(ClinicalTrials.gov)
October 15, 201815/10/2018Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisMulticenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: BOTOX® solution;Drug: Placebo groupAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll91Phase 3France
38EUCTR2017-000372-29-PL
(EUCTR)
28/09/201802/07/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
39EUCTR2016-003417-95-NL
(EUCTR)
18/09/201809/07/2018Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GSK2330811 Solution for Injection, 100mg/ml
Product Code: GSK2330811
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;United Kingdom
40NCT03558854
(ClinicalTrials.gov)
August 28, 20183/5/2018Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma PatientsEvaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic SclerosisSystemic SclerosisDrug: Acetylsalicylic acid;Drug: Placebo oral capsuleFederal University of São PauloNULLRecruiting18 Years65 YearsAll70Phase 4Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2017-000372-29-NL
(EUCTR)
21/06/201824/01/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of
42NCT03856853
(ClinicalTrials.gov)
June 15, 201826/2/2019Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung DiseaseA Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)Drug: Pirfenidone;Other: placeboBeijing Continent Pharmaceutical Co, Ltd.Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)Recruiting18 Years75 YearsAll144Phase 3China
43EUCTR2017-000372-29-ES
(EUCTR)
25/04/201802/02/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
44EUCTR2017-000372-29-GB
(EUCTR)
20/03/201807/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Corbus pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
45EUCTR2017-000372-29-DE
(EUCTR)
07/03/201813/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Corbus pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03708718
(ClinicalTrials.gov)
December 21, 20178/10/2018Prednisolone in Early Diffuse Systemic SclerosisA Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)Systemic SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'Prof. Ariane herrickVersus ArthritisRecruiting18 YearsN/AAll72Phase 2United Kingdom
47NCT03398837
(ClinicalTrials.gov)
December 18, 20175/1/2018Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
48NCT04274257
(ClinicalTrials.gov)
December 4, 201713/2/2020A Study of the Efficacy and Safety of Rituximab in Participants With Systemic SclerosisDouble-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic SclerosisScleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen DiseasesDrug: Double-Blind Placebo;Drug: Double-Blind RituximabTokyo UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Completed20 Years80 YearsAll56Phase 2/Phase 3Japan
49NCT03221257
(ClinicalTrials.gov)
November 28, 201712/7/2017Scleroderma Lung Study III - Combining Pirfenidone With MycophenolateScleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung DiseaseScleroderma, Systemic;Interstitial Lung DiseaseDrug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)Michael RothUniversity of Michigan;Genentech, Inc.;University of California, Los AngelesActive, not recruiting18 YearsN/AAll150Phase 2United States
50NCT03274076
(ClinicalTrials.gov)
September 25, 201728/8/2017Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability StudySystemic Sclerosis;SclerodermaDrug: Tofacitinib;Drug: Placebo Oral TabletUniversity of MichiganPfizerCompleted18 Years70 YearsAll15Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03222492
(ClinicalTrials.gov)
September 20, 201717/7/2017Brentuximab Vedotin for Systemic SclerosisEvaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSScBiological: Brentuximab Vedotin;Biological: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Seagen Inc.Recruiting18 Years70 YearsAll24Phase 1/Phase 2United States;Canada
52EUCTR2015-001617-27-BG
(EUCTR)
02/08/201717/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
53EUCTR2015-000392-28-CZ
(EUCTR)
27/06/201727/04/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
54NCT03120533
(ClinicalTrials.gov)
June 20, 201723/3/2017Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyTherapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyScleroderma, SystemicDrug: Iontophoresis of treprostinil;Drug: Iontophoresis of placeboUniversity Hospital, GrenobleLinksium;University Grenoble AlpsCompleted18 YearsN/AAll18Phase 1/Phase 2France
55EUCTR2015-000392-28-HU
(EUCTR)
08/06/201726/04/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Boehringer Ingelheim RCV GmbH & Co KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03041025
(ClinicalTrials.gov)
June 5, 201731/1/2017Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic SclerosisA Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic SclerosisScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll35Phase 2United States;Canada;Netherlands;United Kingdom
57EUCTR2015-000392-28-NO
(EUCTR)
02/06/201715/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Norway KSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
58EUCTR2015-001617-27-SI
(EUCTR)
26/05/201715/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
59EUCTR2015-000392-28-AT
(EUCTR)
12/05/201731/03/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia
60EUCTR2015-000392-28-SE
(EUCTR)
08/05/201724/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03068234
(ClinicalTrials.gov)
May 201716/2/2017Pirfenidone as Treatment of Skin Fibrosis in Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic SclerosisSystemic SclerosisDrug: Pirfenidone;Drug: Placebo oral capsule;Drug: SteroidsRenJi HospitalNULLNot yet recruiting18 Years70 YearsAll72Phase 2/Phase 3China
62EUCTR2015-000392-28-FI
(EUCTR)
21/02/201710/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Boehringer Ingelheim Finland KyNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
63EUCTR2015-002586-39-BE
(EUCTR)
19/01/201714/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany
64EUCTR2016-003417-95-GB
(EUCTR)
13/01/201724/10/2016Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GSK2330811 Solution for Injection, 100mg/ml
Product Code: GSK2330811
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Netherlands;United Kingdom
65NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03059979
(ClinicalTrials.gov)
January 201725/1/2017The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.Systemic Sclerosis;Raynaud PhenomenaDrug: Methylprednisolone;Other: sodium chlorideRadboud UniversityNULLRecruiting18 YearsN/AAll30Early Phase 1Netherlands
67EUCTR2016-001028-80-IT
(EUCTR)
19/12/201605/11/2020Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study - NA Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NA
Product Code: SAR156597
INN or Proposed INN: non applicabile
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
68JPRN-UMIN000024818
2016/12/1214/11/2016The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosisThe efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis - The efficacy and safety of BTX-B on digital ulcers in patients with SSc digital ulcers in systemic sclerosis patientsplacebo subcutaneously injection into hands with digital ulcers
botulinum toxin type B subcutaneously injection into hands with digital ulcers
Gunma University HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female20Not selectedJapan
69NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
70NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.Systemic Sclerosis;Pulmonary; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02921971
(ClinicalTrials.gov)
November 23, 201630/9/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept StudySystemic SclerosisDrug: SAR156597 (ACT14604);Drug: PlaceboSanofiNULLCompleted18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
72EUCTR2016-001028-80-DE
(EUCTR)
08/11/201618/07/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
73EUCTR2015-002586-39-GB
(EUCTR)
18/10/201619/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom
74EUCTR2015-000424-28-IE
(EUCTR)
17/10/201619/08/2016A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
75EUCTR2016-001028-80-EE
(EUCTR)
04/10/201620/09/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2015-002586-39-PT
(EUCTR)
03/10/201606/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
77NCT02896205
(ClinicalTrials.gov)
October 201627/8/2016Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung DiseaseA Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNULLCompleted18 YearsN/AAll41Phase 3India
78EUCTR2016-001028-80-AT
(EUCTR)
30/09/201627/07/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
79EUCTR2016-001028-80-BE
(EUCTR)
26/09/201602/08/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
80EUCTR2015-002586-39-HU
(EUCTR)
20/09/201612/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
medac GmbHNULLNot Recruiting Female: yes
Male: yes
148 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2015-002586-39-FR
(EUCTR)
13/09/201621/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
82NCT02915835
(ClinicalTrials.gov)
September 201615/9/2016Riociguat in Scleroderma Associated Digital UlcersA Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital UlcersScleroderma;Digital UlcersDrug: Riociguat;Drug: PlaceboDinesh Khanna, MD, MSBayerCompleted18 YearsN/AAll17Phase 2United States
83EUCTR2015-005023-11-IT
(EUCTR)
29/08/201623/02/2018Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
Product Code: EMD 525797
INN or Proposed INN: abituzumab
MERCK KGAANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;United Kingdom;Italy
84EUCTR2015-002586-39-DE
(EUCTR)
03/08/201629/06/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
85EUCTR2015-002586-39-IT
(EUCTR)
27/07/201606/02/2018Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Metoclopramide
Product Code: /
INN or Proposed INN: METOCLOPRAMIDE
Other descriptive name: METOCLOPRAMIDE
MEDAC GMBHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-005023-11-PL
(EUCTR)
12/07/201620/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
87EUCTR2015-005023-11-GB
(EUCTR)
08/07/201625/05/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
88EUCTR2015-005023-11-ES
(EUCTR)
04/07/201627/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
89EUCTR2015-000392-28-IE
(EUCTR)
27/06/201613/04/2016A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
90EUCTR2015-001617-27-NL
(EUCTR)
07/06/201606/04/2016A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02745145
(ClinicalTrials.gov)
May 31, 201615/4/2016Abituzumab in SSc-ILDA Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
92EUCTR2015-004613-24-NL
(EUCTR)
30/05/201613/04/2016Hit hard and earlyHit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: methylprednisolon
INN or Proposed INN: methylprednisolon
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
93EUCTR2015-000392-28-PL
(EUCTR)
09/03/201621/01/2016A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim RCV GmbH&Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden
94NCT02370693
(ClinicalTrials.gov)
March 201611/2/2015Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary FibrosisComparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558Interstitial Lung Disease;ILD;Systemic Sclerosis;SclerodermaDrug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetilNorthwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 YearsN/AAll30Phase 2United States
95NCT02588625
(ClinicalTrials.gov)
February 201626/10/2015A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)SclerodermaDrug: BMS-986020;Other: PlaceboBristol-Myers SquibbNULLWithdrawn18 YearsN/ABoth0Phase 2United States;Canada;Poland;United Kingdom;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2015-000424-28-GR
(EUCTR)
26/01/201630/12/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
97JPRN-JapicCTI-152963
08/1/201609/07/2015Phase III Study of Tocilizumab in Patients with Systemic SclerosisA PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic SclerosisIntervention name : Tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo/W, SC
Chugai Pharmaceutical Co., Ltd.F.Hoffmann-La Roche Ltdcomplete18BOTH210Phase 3Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
98EUCTR2015-000392-28-PT
(EUCTR)
08/01/201614/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
99NCT02530996
(ClinicalTrials.gov)
January 1, 201629/7/2015Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentSystemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentRheumatologic DiseaseDrug: BH4;Other: Vasculopathy assessment;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years95 YearsAll32United States
100NCT03141125
(ClinicalTrials.gov)
January 201620/6/2016The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard TherapyThe Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and FibrosisSclerodermaOther: Physalis angulata ethanol extract;Other: PlaceboIndonesia UniversityNetherlands: Ministry of Health, Welfare and SportsCompleted18 Years60 YearsAll62N/AIndonesia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-000424-28-NL
(EUCTR)
22/12/201521/09/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
102EUCTR2015-000424-28-HR
(EUCTR)
18/12/201501/02/2016A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Lithuania;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Japan
103EUCTR2015-000392-28-FR
(EUCTR)
11/12/201514/12/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
104EUCTR2015-000392-28-BE
(EUCTR)
08/12/201525/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
520Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
105NCT02453256
(ClinicalTrials.gov)
November 20, 201521/5/2015A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic SclerosisSystemic SclerosisDrug: Placebo;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll212Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2015-000392-28-ES
(EUCTR)
19/11/201505/10/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
107EUCTR2015-000392-28-GR
(EUCTR)
18/11/201522/10/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Ellas SANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
108NCT02597933
(ClinicalTrials.gov)
November 12, 20158/10/2015A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung FibrosisA Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)Scleroderma, SystemicDrug: Nintedanib;Drug: PlaceboBoehringer IngelheimNULLCompleted18 YearsN/AAll580Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
109EUCTR2015-000392-28-DE
(EUCTR)
11/11/201525/08/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
110EUCTR2015-000392-28-GB
(EUCTR)
10/11/201501/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2015-000424-28-DE
(EUCTR)
02/11/201527/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
112EUCTR2015-000392-28-NL
(EUCTR)
02/11/201524/08/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
113NCT03531216
(ClinicalTrials.gov)
November 2, 20159/5/2018Topical Rosemary Oil Application in Systemic SclerosisPsychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized TrialSystemic SclerosisOther: Rosemary essential oil;Other: PlaceboARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity Hospital TuebingenCompleted18 YearsN/AAll12N/AGermany
114NCT02503644
(ClinicalTrials.gov)
October 29, 201530/6/2015Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic SclerosisScleroderma, Diffuse;Diffuse Cutaneous Systemic SclerosisDrug: IVA337;Drug: PlaceboInventiva PharmaNULLCompleted18 Years75 YearsAll145Phase 2Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
115EUCTR2015-001617-27-DE
(EUCTR)
23/10/201528/08/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2015-000424-28-LT
(EUCTR)
14/10/201529/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
117EUCTR2015-000392-28-DK
(EUCTR)
22/09/201522/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
118EUCTR2015-000424-28-HU
(EUCTR)
22/09/201511/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
119EUCTR2015-001617-27-IT
(EUCTR)
18/09/201517/06/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
120EUCTR2015-001617-27-GB
(EUCTR)
16/09/201517/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2014-005323-27-GB
(EUCTR)
16/09/201529/09/2015A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosisA phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET) Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 18.0;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
University of MichiganNULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Italy;United Kingdom
122EUCTR2015-000424-28-DK
(EUCTR)
10/09/201517/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
123EUCTR2015-001617-27-ES
(EUCTR)
08/09/201510/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
124EUCTR2015-000424-28-BE
(EUCTR)
07/09/201528/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
125NCT02551042
(ClinicalTrials.gov)
September 201517/12/2014CSL Behring Sclero XIIIA Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic SclerosisSystemic SclerosisDrug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chlorideUniversity College, LondonCSL BehringRecruiting18 YearsN/ABoth26Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2015-000424-28-ES
(EUCTR)
07/08/201504/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
127NCT02465437
(ClinicalTrials.gov)
August 20154/6/2015Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: JBT-101;Drug: Placebo;Drug: Part B Open-Label ExtensionCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 Years70 YearsAll42Phase 2United States
128EUCTR2015-000424-28-PT
(EUCTR)
31/07/201530/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
129NCT02349009
(ClinicalTrials.gov)
June 201518/1/2015Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialA Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialSystemic SclerodermaDrug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, PlaceboPrism Pharma Co., Ltd.NULLCompleted18 YearsN/AAll17Phase 1/Phase 2United States
130NCT02386436
(ClinicalTrials.gov)
April 21, 20156/3/2015A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy SubjectsA Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy SubjectsScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years65 YearsAll41Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2014-001353-16-GB
(EUCTR)
17/04/201503/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 m
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
132EUCTR2014-001101-40-GB
(EUCTR)
24/02/201514/01/2015Investigation of safety and therapeutic effect of Fibrogammin® in SclerodermaSclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII Systemic Sclerosis
MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859
MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
University College London (UCL)NULLNot Recruiting Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
133EUCTR2014-001353-16-DE
(EUCTR)
19/02/201516/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
134NCT02370784
(ClinicalTrials.gov)
February 201526/1/2015Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse SclerodermaThe Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic SclerosisSclerodermaDrug: atorvastatin;Drug: PlaceboRobyn T. Domsic, MD, MPHNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll24Phase 2United States
135EUCTR2014-001353-16-CZ
(EUCTR)
22/01/201506/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2014-001353-16-IT
(EUCTR)
19/01/201514/05/2015Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
137NCT02283762
(ClinicalTrials.gov)
January 15, 20153/11/2014Efficacy and Safety of Riociguat in Patients With Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)Scleroderma, SystemicDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 YearsN/AAll121Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
138NCT02165111
(ClinicalTrials.gov)
January 201511/6/2014Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's SyndromeA Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's SyndromeScleroderma;Raynaud's SyndromeDrug: Onabotulinumtoxin A;Drug: sterile saline solutionJohns Hopkins UniversityAllerganCompleted18 YearsN/AAll40Phase 3United States
139EUCTR2014-001353-16-NL
(EUCTR)
31/12/201420/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
140EUCTR2014-001353-16-HU
(EUCTR)
30/12/201414/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2014-001353-16-ES
(EUCTR)
22/12/201403/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
142EUCTR2014-001353-16-BE
(EUCTR)
09/12/201421/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
143NCT02228850
(ClinicalTrials.gov)
November 201420/8/2014Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisA Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Alprostadil;Other: PlaceboNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)NULLCompleted18 Years79 YearsBoth35Phase 2United States
144EUCTR2014-000865-34-DE
(EUCTR)
31/10/201410/09/2014A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic SclerosisA multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom
145NCT02047708
(ClinicalTrials.gov)
October 201422/1/2014Zibotentan Better Renal Scleroderma Outcome StudyA Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to SclerodermaScleroderma;Scleroderma Renal Crisis;Chronic Kidney DiseaseDrug: ZibotentanUniversity College, LondonMedical Research CouncilCompleted18 YearsN/AAll27Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT02260557
(ClinicalTrials.gov)
October 20146/10/2014Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic SclerosisA Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud's Phenomenon Secondary to Systemic SclerosisDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth74Phase 2France;Germany;United Kingdom
147EUCTR2014-000865-34-GB
(EUCTR)
16/09/201410/09/2014A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic SclerosisA multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom
148NCT02161406
(ClinicalTrials.gov)
September 20143/6/2014A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic SclerosisA Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.Diffuse Cutaneous Systemic SclerosisDrug: Abatacept;Drug: PlaceboDinesh Khanna, MD, MSBristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)Completed18 YearsN/AAll88Phase 2United States;Canada;United Kingdom
149NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
150EUCTR2013-003200-39-GB
(EUCTR)
01/04/201404/04/2014Investigation of Zibotentan for kidney disease in sclerodermaA phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA) Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease).
MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857
MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
University College LondonNULLNot Recruiting Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2010-022710-77-CZ
(EUCTR)
06/01/201402/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
152EUCTR2012-004955-35-IT
(EUCTR)
29/07/201330/05/2013A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy” SYSTEMIC SCLEROSIS
MedDRA version: 16.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabtheraPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
153NCT01878526
(ClinicalTrials.gov)
June 20137/6/2013Gastroesophageal Reflux Treatment in SclerodermaThe Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic SclerosisGastroesophageal Reflux Disease;Systemic Sclerosis;SclerodermaDrug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)Khon Kaen UniversityNULLCompleted18 Years65 YearsAll80Phase 3Thailand
154NCT01804959
(ClinicalTrials.gov)
May 20133/3/2013Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseA Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseSystemic SclerosisDietary Supplement: Vivomixx probioticsSingapore General HospitalNULLUnknown status18 YearsN/AAll40Phase 2Singapore
155NCT01748084
(ClinicalTrials.gov)
April 9, 201310/12/2012Rituximab in Systemic SclerosisEvaluation of Rituximab in Systemic Sclerosis Associated PolyarthritisSystemic SclerosisDrug: Rituximab;Drug: Placebo (NaCl)Assistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll22Phase 2/Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringUnknown status18 YearsN/AAll14N/AUnited States
157EUCTR2012-001369-34-IT
(EUCTR)
12/02/201321/12/2012Proof of biological activity of SAR100842 in Systemic SclerosisDouble-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: NA
Product Code: SAR100842
Product Name: NA
Product Code: SAR100842
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
30United States;Canada;Germany;United Kingdom;Switzerland;Italy
158NCT01570764
(ClinicalTrials.gov)
January 14, 20132/4/2012Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung DiseaseIntravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung FibrosisDrug: Cyclophosphamide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisHôpital Claude-HuriezCompleted18 YearsN/AAll40Phase 3France
159NCT01651143
(ClinicalTrials.gov)
January 201324/7/2012Proof of Biological Activity of SAR100842 in Systemic SclerosisDouble-blind, Randomized, Placebo-controlled, 8-week Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: SAR100842;Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth30Phase 2United States;France;Italy;Switzerland;United Kingdom;Germany
160EUCTR2012-001369-34-DE
(EUCTR)
19/11/201217/08/2012Proof of biological activity of SAR100842 in Systemic SclerosisInitial title : Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic SclerosisRevised title according to the protocol amendment 4 :Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: SAR100842
Product Code: SAR100842
Sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
30United States;Canada;Germany;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2012-001369-34-GB
(EUCTR)
26/10/201215/06/2012Proof of biological activity of SAR100842 in Systemic SclerosisDouble-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Sanofi-aventis recherche & développementNULLNot 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): noUnited States;Canada;Germany;Italy;Switzerland;United Kingdom
162NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung DiseaseA Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
163NCT01670565
(ClinicalTrials.gov)
August 201215/8/2012Belimumab for the Treatment of Diffuse Cutaneous Systemic SclerosisBelimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.Systemic SclerosisDrug: BelimumabHospital for Special Surgery, New YorkHuman Genome Sciences Inc.Completed18 YearsN/AAll20Phase 2United States
164EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
165EUCTR2010-022710-77-PL
(EUCTR)
30/05/201212/03/2012A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2010-022969-95-PL
(EUCTR)
30/05/201212/03/2012A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
167EUCTR2010-022710-77-IT
(EUCTR)
11/04/201209/02/2012A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis) Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
168EUCTR2010-022969-95-GR
(EUCTR)
02/04/201228/03/2012A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
169EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
170EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
172EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden
173NCT01532869
(ClinicalTrials.gov)
March 201210/2/2012A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic SclerosisA Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic SclerosisSclerosis, SystemicDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll87Phase 3United States;Canada;France;Germany;United Kingdom
174NCT01553981
(ClinicalTrials.gov)
March 201211/3/2012A Trial of Tadalafil in Interstitial Lung Disease of SclerodermaA Double Blind Randomized Control Trial of Tadalafil in Interstitial Lung Disease of SclerodermaLung Diseases, InterstitialDrug: Tadalafil;Drug: PlaceboSanjay Gandhi Postgraduate Institute of Medical SciencesNULLCompleted18 Years70 YearsBoth40Phase 3India
175EUCTR2010-022969-95-NL
(EUCTR)
27/02/201212/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2010-022969-95-PT
(EUCTR)
03/02/201212/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
177EUCTR2011-001460-22-GB
(EUCTR)
19/01/201217/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Germany;United Kingdom
178EUCTR2010-022969-95-BE
(EUCTR)
16/01/201229/11/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Phase 3Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
179EUCTR2010-022710-77-FI
(EUCTR)
10/01/201207/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
180EUCTR2010-022969-95-GB
(EUCTR)
21/12/201127/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Phase 3Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2010-022969-95-IE
(EUCTR)
07/12/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
182NCT01474122
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisDigital UlcersDrug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: PlaceboActelionNULLTerminated18 YearsN/AAll265Phase 3United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
183NCT01474109
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisSystemic Sclerosis;UlcersDrug: macitentan 3mg;Drug: macitentan 10mg;Drug: placeboActelionNULLCompleted18 YearsN/AAll289Phase 3United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
184NCT01538719
(ClinicalTrials.gov)
December 201121/2/2012IL1-TRAP, Rilonacept, in Systemic SclerosisRandomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker TrialScleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic SclerosisDrug: Rilonacept;Other: PlaceboBoston UniversityRegeneron PharmaceuticalsCompleted18 YearsN/AAll24Phase 1/Phase 2United States
185EUCTR2011-001460-22-DE
(EUCTR)
28/11/201120/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
86Phase 2/3France;United States;Canada;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2010-022710-77-BG
(EUCTR)
17/11/201126/08/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
187EUCTR2010-022969-95-DE
(EUCTR)
09/08/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
188NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
189EUCTR2010-022710-77-DE
(EUCTR)
16/06/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
190EUCTR2010-022969-95-ES
(EUCTR)
26/05/201118/11/2011A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis. Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT01257802
(ClinicalTrials.gov)
May 20119/12/2010GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesGnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesLupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial DiffuseDrug: depot leuprolide acetate 3.75 mg;Drug: PlaceboJoseph MccuneNational Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Terminated18 Years40 YearsFemale14Phase 3United States
192NCT01347008
(ClinicalTrials.gov)
April 20112/5/2011Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic SclerosisEffect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical TrialScleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud PhenomenonDrug: Sildenafil citrate;Drug: Placebo (Sugar pill)Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted18 YearsN/AFemale41Phase 3Brazil
193EUCTR2010-022710-77-DK
(EUCTR)
22/03/201103/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
194EUCTR2010-024005-13-GB
(EUCTR)
11/03/201130/12/2010A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: alpha-2C AR antagonist
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: Alpha-2C AR antagonist
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
195NCT01315899
(ClinicalTrials.gov)
March 201114/3/2011Efficacy of ORM-12741 for Prevention of Raynaud's PhenomenonPhase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud's PhenomenonDrug: ORM-12471 30mg;Drug: ORM-12471;Drug: placeboOrion Corporation, Orion PharmaNULLTerminated18 Years75 YearsBoth15Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2010-022710-77-HU
(EUCTR)
28/02/201101/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
197NCT01295736
(ClinicalTrials.gov)
November 201011/2/2011Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDYEvaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled StudySystemic SclerodermaDrug: Sildenafil;Drug: placeboUniversity Hospital, LilleNULLCompleted18 YearsN/ABoth84Phase 3France
198NCT00946699
(ClinicalTrials.gov)
March 201023/7/2009A Study of the Safety and Tolerability of MEDI-551 in SclerodermaA Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in SclerodermaSclerodermaBiological: MEDI-551;Biological: Placebo;Other: PlaceboMedImmune LLCNULLCompleted18 YearsN/ABoth50Phase 1United States;Canada;United Kingdom
199NCT01117298
(ClinicalTrials.gov)
November 20093/5/2010A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in SclerodermaA Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric StudyRaynaud's Phenomenon;Digital Ulcers;SclerodermaDrug: Tadalafil;Drug: PlaceboSanjay Gandhi Postgraduate Institute of Medical SciencesInstitute of Postgraduate Medical Education and Research;Postgraduate Institute of Medical Education and Research;Army Research and Referral hospitalCompleted18 Years65 YearsBoth66Phase 3India
200NCT00883129
(ClinicalTrials.gov)
September 200916/4/2009Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: PlaceboMichael RothNational Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La RocheCompleted18 YearsN/AAll142Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2007-002015-38-IT
(EUCTR)
05/06/200919/06/2009Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - NDPhase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND Skin Fibrosis in patients with systemic sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144ISDIN S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
202NCT00775463
(ClinicalTrials.gov)
May 200917/10/2008Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineDISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter StudySystemic Sclerosis;SclerodermaDrug: treprostinil diethanolamine;Drug: placeboUnited TherapeuticsNULLCompleted18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
203EUCTR2007-003621-24-AT
(EUCTR)
30/03/200923/04/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
204EUCTR2008-005018-39-GB
(EUCTR)
05/03/200922/05/2009DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 Systemic Sclerosis, scleroderma digital ulcers
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150United Kingdom
205EUCTR2007-003621-24-GB
(EUCTR)
02/12/200814/07/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MondoGEN AGNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT00769028
(ClinicalTrials.gov)
December 20087/10/2008AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisA Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Hyperimmune caprine serum;Drug: AlbuminDaval International LimitedNULLActive, not recruiting18 YearsN/ABoth20Phase 2United Kingdom
207NCT00442611
(ClinicalTrials.gov)
November 20081/3/2007A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic SclerosisScleroderma, Diffuse;Scleroderma, SystemicDrug: Abatacept;Drug: PlaceboStanford UniversityBristol-Myers SquibbCompleted18 YearsN/AAll10Phase 1/Phase 2United States
208NCT00984932
(ClinicalTrials.gov)
September 200824/9/2009Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary HypertensionThe Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled TrialSystemic SclerosisDrug: RosuvastatinFaculty of Medicine, University of AlexandriaNULLCompletedN/AN/ABoth40Phase 3Egypt
209EUCTR2007-003621-24-NL
(EUCTR)
23/07/200813/03/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
210EUCTR2007-003621-24-IT
(EUCTR)
15/07/200817/11/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - NDDouble-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
MONDOGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2007-003621-24-BE
(EUCTR)
20/06/200808/01/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
212EUCTR2007-003621-24-FR
(EUCTR)
29/05/200827/12/2007Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
213EUCTR2007-003122-24-GB
(EUCTR)
09/04/200815/02/2008A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosisA Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis
MedDRA version: 9.1;Classification code 10036814;Term: Progressive systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma
MedDRA version: 9.1;Classification code 10012941;Term: Diffuse scleroderma
MedDRA version: 9.1;Classification code 10018124;Term: Generalized scleroderma
MedDRA version: 9.1;Classification code 10042954;Term: Systemic sclerosis pulmonary
Daval International LimitedNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
214NCT01545427
(ClinicalTrials.gov)
April 20081/3/2012Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaA Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaSclerodermaDrug: Imatinib mesylate;Other: PlaceboLawson Health Research InstituteNovartis PharmaceuticalsTerminated18 YearsN/ABoth10Phase 2Canada
215EUCTR2007-003621-24-DE
(EUCTR)
20/03/200813/02/2009Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2007-002015-38-DE
(EUCTR)
20/12/200703/08/2007PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Hungary;Spain;Germany;Italy;United Kingdom
217EUCTR2007-002015-38-GB
(EUCTR)
19/12/200731/07/2007 PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
ISDINNULLNot Recruiting Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Germany;Italy;United Kingdom
218NCT00581997
(ClinicalTrials.gov)
December 200721/12/2007QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System SclerosisPulmonary Fibrosis Secondary to Systemic SclerosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsBoth8Phase 2United States
219NCT00479934
(ClinicalTrials.gov)
December 200729/5/2007Efficacy and Safety of Imatinib in SclerodermaPhase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.Scleroderma, Localized;Scleroderma, SystemicDrug: imatinib mesylateUniversity Hospital, BordeauxMinistry of Health, France;NovartisCompleted18 YearsN/ABoth28Phase 2France
220NCT00577304
(ClinicalTrials.gov)
December 200718/12/2007A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's PhenomenonA Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's PhenomenonRaynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Other Autoimmune DiseaseDrug: Nitroglycerin;Drug: Topical AmphiMatrixMediQuest TherapeuticsNULLActive, not recruiting15 Years70 YearsBoth200Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2007-002015-38-HU
(EUCTR)
04/09/200709/07/2007Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
222NCT00574613
(ClinicalTrials.gov)
September 200713/12/2007Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic SclerosisPhase II, Multicenter, Randomized, Double-blind, Intraindividually Placebo Controlled Clinical Trial, to Evaluate Efficacy and Safety of p144 Topical Administration for Skin Fibrosis in Patients With Systemic SclerosisSkin FibrosisDrug: P144;Drug: placeboISDINDigna Biotech S.L.Completed18 Years65 YearsBoth56Phase 2Germany;Hungary;Italy;Poland;Spain;United Kingdom
223EUCTR2007-002015-38-ES
(EUCTR)
23/08/200702/07/2007ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSISENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
224NCT00419419
(ClinicalTrials.gov)
December 20064/1/2007Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's PhenomenonPhase III In-Life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's PhenomenonRaynaud's Disease;Scleroderma;Autoimmune DiseasesDrug: Topical AmphiMatrix with nitroglycerin (MQX-503)MediQuest TherapeuticsNULLCompleted18 Years70 YearsBoth80Phase 3United States;Sweden;United Kingdom
225EUCTR2005-004979-37-GB
(EUCTR)
27/11/200618/09/2006 Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as sclerodermaMediQuest Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2005-004979-37-SE
(EUCTR)
27/10/200608/09/2006Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Moderate to severe primary Raynaud’s,OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as sclerodermaProduct Name: MQX-503
Product Code: MQX-503
INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP
Other descriptive name: Nitroglycerine gel
MediQuest Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Sweden
227NCT00377455
(ClinicalTrials.gov)
September 200614/9/2006Placebo Controlled Trial of Bosentan in Scleroderma PatientsPlacebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary HypertensionSystemic Scleroderma;Pulmonary HypertensionDrug: Bosentan;Drug: PlaceboGeorgetown UniversityActelionTerminated18 YearsN/AAll5Phase 2United States
228NCT00348296
(ClinicalTrials.gov)
July 20063/7/2006Efficacy and Safety Study of GB-0998 for Treatment of Systemic SclerosisA Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic SclerosisScleroderma, SystemicDrug: High-dose intravenous immunoglobulin (Venoglobulin-IH)Benesis CorporationNULLCompleted16 YearsN/ABoth60Phase 3Japan
229EUCTR2006-000905-41-AT
(EUCTR)
07/06/200608/05/2006Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaudOffene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud Raynaud syndrome with / without systemic sclerosisTrade Name: Ilomedin
Product Name: Ilomedin
Product Code: 1-22460
ao. Univ. Prof. Dr. Elisabeth AbererNULLNot RecruitingFemale: yes
Male: yes
Phase 4Austria
230NCT00740285
(ClinicalTrials.gov)
April 200419/8/2008Effectiveness and Safety of Lidocaine for SclerodermaEffectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical TrialSclerodermaDrug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9%Federal University of São PauloNULLCompleted18 Years60 YearsBoth26Phase 2/Phase 3Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT02800993
(ClinicalTrials.gov)
October 200313/6/2016Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisSystemic Sclerosis;Digital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada
232NCT00077584
(ClinicalTrials.gov)
October 200310/2/2004Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisDigital Ulcers;Systemic SclerosisDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada
233NCT00070590
(ClinicalTrials.gov)
July 20036/10/2003Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With SclerodermaA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic SclerosisPulmonary Fibrosis;Scleroderma, SystemicDrug: BosentanActelionNULLCompleted18 YearsN/ABoth132Phase 2/Phase 3United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom
234NCT00043706
(ClinicalTrials.gov)
May 200212/8/2002Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic SclerosisA Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic SclerosisSystemic Sclerosis;SclerodermaDrug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal AntibodyGenzyme, a Sanofi CompanyCambridge Antibody TechnologyCompleted18 Years75 YearsBothPhase 1/Phase 2United States
235NCT00707187
(ClinicalTrials.gov)
July 200125/6/2008Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual DysfunctionRandomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic SclerosisSystemic SclerosisDrug: CialisUniversity of Medicine and Dentistry of New JerseyNULLCompleted18 YearsN/AFemale120Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT00418132
(ClinicalTrials.gov)
August 20003/1/2007Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic SclerosisT Cell Immunity in Collagen Biosynthesis of SclerodermaScleroderma, SystemicDrug: Thalidomide;Drug: Placebo thalidomideNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Terminated18 Years65 YearsBoth30Phase 1United States
237NCT00005675
(ClinicalTrials.gov)
April 200026/5/2000Oral Type I Collagen for Relieving SclerodermaMulticenter Phase II Trial of Oral Type I Bovine Collagen in SclerodermaScleroderma;Connective Tissue DiseasesDrug: Oral bovine type I collagen;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Wayne State University;University of California, Los Angeles;UTHSC;MUSC;Beth Israel Medical Center;University of Alabama at Birmingham;Johns Hopkins University;Georgetown University;Baltimore VA Medical Center;Northwestern UniversityCompleted18 YearsN/ABoth168Phase 2United States
238NCT00004563
(ClinicalTrials.gov)
August 19999/2/2000Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll158Phase 3NULL
239NCT00704665
(ClinicalTrials.gov)
December 199823/6/2008Recombinant Human Relaxin in the Treatment of Diffuse SclerodermaA Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse SclerodermaSystemic SclerosisDrug: RelaxinUniversity of Medicine and Dentistry of New JerseyUniversity of California, Los Angeles;Boston University;University of Chicago;University of Connecticut Health Center;Johns Hopkins University;University of Pittsburgh;Medical University of South Carolina;Stanford University;Georgetown University;University of California, San Diego;Wayne State University;University of Colorado, Denver;Medical College of WisconsinCompleted18 Years70 YearsBoth231Phase 3NULL
240NCT00004786
(ClinicalTrials.gov)
December 199524/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic SclerosisSystemic Sclerosis;Raynaud DiseaseDrug: iloprostNational Center for Research Resources (NCRR)University of PittsburghCompleted18 YearsN/ABoth200Phase 3NULL