HZN-825 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症11
85特発性間質性肺炎4

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-006271-42-GR
(EUCTR)
04/01/202302/11/2022A Open-label Study to Evaluate the Efficacy, Safety, Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
2NCT05626751
(ClinicalTrials.gov)
November 4, 20221/11/2022An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic Sclerosis;Sclerosis, SystemicDrug: HZN-825Horizon Pharma Ireland, Ltd., Dublin IrelandNULLRecruiting18 YearsN/AAll300Phase 2United States;Argentina;France;Greece;Korea, Republic of
3EUCTR2020-005764-62-PL
(EUCTR)
31/01/202205/01/2022A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
4EUCTR2020-005764-62-NL
(EUCTR)
31/01/202225/11/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of
5EUCTR2020-005764-62-IT
(EUCTR)
29/09/202130/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis - - Diffuse Cutaneous 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: HZN-825
Product Code: [HZN-825]
HORIZON THERAPEUTICS IRELAND DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Korea, Democratic People's Republic of;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
6EUCTR2020-005764-62-GR
(EUCTR)
13/09/202109/07/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
7EUCTR2020-005764-62-PT
(EUCTR)
24/08/202119/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of
8EUCTR2020-005764-62-AT
(EUCTR)
16/08/202115/06/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
9EUCTR2020-005764-62-ES
(EUCTR)
11/08/202111/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of
10EUCTR2020-005764-62-DE
(EUCTR)
09/08/202114/06/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous 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 Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
11NCT04781543
(ClinicalTrials.gov)
April 1, 20211/3/2021A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic Sclerosis;Sclerosis, SystemicDrug: HZN-825 BID;Drug: Placebo;Drug: HZN-825 QDHorizon Therapeutics Ireland DACNULLRecruiting18 Years75 YearsAll300Phase 2United States;Argentina;Austria;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Switzerland;United Kingdom

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001253-32-NL
(EUCTR)
11/04/202219/01/2022A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Netherlands;Germany;Korea, Republic of
2EUCTR2021-001253-32-GR
(EUCTR)
04/03/202227/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Germany;Netherlands;Korea, Republic of
3EUCTR2021-001253-32-ES
(EUCTR)
16/02/202207/12/2021A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Other descriptive name: SAR100842
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Korea, Republic of
4NCT05032066
(ClinicalTrials.gov)
August 25, 202127/8/2021A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisA Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: HZN-825;Drug: PlaceboHorizon Therapeutics Ireland DACNULLRecruiting18 YearsN/AAll135Phase 2United States;Argentina;Australia;Canada;Chile;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;South Africa;Spain;Taiwan;Turkey