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ACTIVE NOT RECRUITING Phase 3

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

NCT03950232 · View on ClinicalTrials.gov ↗

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 \[NCT04607837\]).

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

FieldValue
Enrollment Target 896 participants
Start Date 2019-09-05
Est. Completion 2029-06-19
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03950232

The ClinicalTrials.gov registry entry for NCT03950232 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 896 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03950232 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03950232?

The interventions under investigation include: Etrasimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03950232?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial