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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 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 138 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03142191
The ClinicalTrials.gov registry entry for NCT03142191 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03142191 reports 0 study locations.
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.
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