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NCT04090411 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 246
- Enrollment target
NCT04090411 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 246 participants.
The verdict
NCT04090411, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 246 participants
- Enrollment target
Study Summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Interventions
- DRUG Induction- PF-06480605 50 mg SC Q4W
- DRUG Induction- PF-06480605 150 mg SC Q4W
- DRUG Induction- PF-06480605 450 mg SC Q4W
- OTHER Induction- Placebo SC Q4W
- DRUG Chronic- PF-06480605 50 mg SC Q4W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2022-10-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090411
The ClinicalTrials.gov registry entry for NCT04090411 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Induction- PF-06480605 50 mg SC Q4W is the first listed.
NCT04090411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04090411 about?
NCT04090411 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis". This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
What is the current status of trial NCT04090411?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2019-12-19. Estimated completion is 2022-10-25.
What interventions are being tested in trial NCT04090411?
The interventions under investigation include: Induction- PF-06480605 50 mg SC Q4W (DRUG), Induction- PF-06480605 150 mg SC Q4W (DRUG), Induction- PF-06480605 450 mg SC Q4W (DRUG), Induction- Placebo SC Q4W (OTHER), Chronic- PF-06480605 50 mg SC Q4W (DRUG).
Who is sponsoring clinical trial NCT04090411?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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