SAR100842 ( 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4
85特発性間質性肺炎2

51. 全身性強皮症

臨床試験数 : 523 /  薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2012-001369-34-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
2NCT01651143
(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
3EUCTR2012-001369-34-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
4EUCTR2012-001369-34-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]		Product Code: SAR100842
Product Code: SAR100842		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

85. 特発性間質性肺炎

臨床試験数 : 598 /  薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
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-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
2EUCTR2021-001253-32-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

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