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NCT03142191 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT03142191: Clinical Trial Phase 2 study, sponsored by Celgene.
NCT03142191 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03142191, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.
Primary Outcome
Mean change from baseline in percentage point difference in % predicted forced vital capacity (FVC) FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.
Interventions
- OTHER Placebo
- DRUG CC-90001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2021-12-24 |
| Phase | Phase 2 |
Why NCT03142191 stopped before completion
NCT03142191 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03142191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03142191 about?
NCT03142191 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis". This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered...
What is the current status of trial NCT03142191?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2017-07-26. Estimated completion is 2021-12-24.
What interventions are being tested in trial NCT03142191?
The interventions under investigation include: Placebo (OTHER), CC-90001 (DRUG).
Who is sponsoring clinical trial NCT03142191?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03142191's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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