Trials / Terminated
TerminatedNCT01559129
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.
Conditions
- Scleroderma, Systemic
- Sclerosis, Systemic
- Systemic Scleroderma
- Systemic Sclerosis
- Interstitial Lung Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pomalidomide (CC-4047) | 1 mg orally every day for 52 weeks |
| DRUG | Placebo | Matching placebo capsules taken orally once a day |
Timeline
- Start date
- 2012-08-09
- Primary completion
- 2016-11-03
- Completion
- 2016-11-03
- First posted
- 2012-03-21
- Last updated
- 2023-12-01
- Results posted
- 2019-10-18
Locations
56 sites across 10 countries: United States, Australia, France, Germany, Italy, Poland, Russia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01559129. Inclusion in this directory is not an endorsement.