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NCT03950232 · ClinicalTrials.gov registry record · Phase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 896
- Enrollment target
- 20
- Study locations
NCT03950232: Active Phase 3 study of Ulcerative Colitis, sponsored by Pfizer.
NCT03950232 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 896 participants, below the 2,050-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03950232, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 896 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).
Primary Outcome
Safety as assessed by the evaluation of adverse events
Conditions Studied
Interventions
- DRUG Etrasimod
Study Locations (20)
California
- Inland Pulmonary Specialists [PFT Only] - Lake Elsinore
- A V Pediatrics,Allergy and Family Medicine - Lancaster
- Advanced Endoscopy and Pain Center(Colonoscopy) - Lancaster
- Antelope Valley Eye Care(Ophthalmologist) - Lancaster
- Jatinder S.Pruthi,MD FACG CPI - Lancaster
- Om Research LLC - Lancaster
- Renaissance Imaging Center(Chest X-Ray only) - Lancaster
- United Surgery Center Murrieta [Endoscopy Only] - Murrieta
- United Medical Doctors - Murrieta
- Advanced Imaging (Chest X-Ray) - Palmdale
- California Eye Professionals [OCT Only] - Temecula
- United Surgery Center Temecula [Endoscopy Only] - Temecula
Alabama
- Center for Digestive Health (Colonoscopy Location) - Dothan
- Pulmonary Associates (Secondary PFT Location) - Dothan
- Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address) - Dothan
Florida
- Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test) - Clearwater
- West Coast Endoscopy Center (Endoscopy Procedures) - Clearwater
- Northwood Vision-Optical Coherence Tomography-(OCT) - Clearwater
Colorado
- Front Range Endoscopy Center - Colorado Springs
- Peak Gastroenterology Associates - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 896 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2029-06-19 |
| Phase | Phase 3 |
What the registry record for NCT03950232 still lists
NCT03950232 is an interventional study that assigns participants to a tested intervention. The registered 896 participants enrollment target is mid-sized for trials with a published cap, below the 2,050-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Etrasimod is the first listed.
NCT03950232 names 20 study sites across 4 states, led by California, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT03950232 about?
NCT03950232 is a clinical study titled "An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis". The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of...
What is the current status of trial NCT03950232?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 896 participants. The study started on 2019-09-05. Estimated completion is 2029-06-19.
What conditions does trial NCT03950232 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT03950232?
The interventions under investigation include: Etrasimod (DRUG).
Who is sponsoring clinical trial NCT03950232?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03950232 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03950232's enrollment target sits among peer trials
896 16th of 122 higher than 107 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
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