51. 全身性強皮症 Scleroderma Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01559129 (ClinicalTrials.gov) | August 9, 2012 | 19/3/2012 | Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease | A 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 | Scleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung Disease | Drug: Pomalidomide (CC-4047);Drug: Placebo | Celgene | NULL | Terminated | 18 Years | 80 Years | All | 23 | Phase 2 | United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom |
| 2 | EUCTR2010-023047-15-PL (EUCTR) | 17/07/2012 | 14/05/2012 | A 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 disease | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland | ||
| 3 | EUCTR2010-023047-15-IT (EUCTR) | 20/03/2012 | 28/12/2011 | A 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 disease | A 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 CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Poland;Spain;Australia;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2010-023047-15-DE (EUCTR) | 15/03/2012 | 08/12/2011 | A 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 disease | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 5 | EUCTR2010-023047-15-GB (EUCTR) | 08/03/2012 | 15/12/2011 | A 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 disease | A 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] | Trade Name: Imnovid 1 mg hard capsules INN or Proposed INN: Pomalidomide | Celgene Corporation | NULL | Not 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): no | France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom | ||
| 6 | EUCTR2010-023047-15-ES (EUCTR) | 02/03/2012 | 19/01/2012 | A 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 disease | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden |