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

Running, not enrolling · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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 \[NCT04607837\]).

Key facts

Study ID

NCT03950232

Run by

Pfizer

People needed

896

Starts

2019-09-05

Expected to finish

2029-06-19

Last updated by the study team

2026-07-09

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
• Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
• Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

You may not qualify if…

• If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
• Experienced an adverse event that led to discontinuation from parent study

Where it is running

• Digestive Health Specialists (IP Address) — Dothan, Alabama, United States
• Flowers Hospital (PFT Location) — Dothan, Alabama, United States
• Pulmonary Associates (Secondary PFT Location) — Dothan, Alabama, United States
• Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address) — Dothan, Alabama, United States
• Inland Pulmonary Specialists [PFT Only] — Lake Elsinore, California, United States
• A V Pediatrics,Allergy and Family Medicine — Lancaster, California, United States
• Advanced Endoscopy and Pain Center(Colonoscopy) — Lancaster, California, United States
• Antelope Valley Eye Care(Ophthalmologist) — Lancaster, California, United States
• Jatinder S.Pruthi,MD FACG CPI — Lancaster, California, United States
• Om Research LLC — Lancaster, California, United States
• Renaissance Imaging Center(Chest X-Ray only) — Lancaster, California, United States
• United Surgery Center Murrieta [Endoscopy Only] — Murrieta, California, United States
• United Medical Doctors — Murrieta, California, United States
• Advanced Imaging (Chest X-Ray) — Palmdale, California, United States
• California Eye Professionals [OCT Only] — Temecula, California, United States
• United Surgery Center Temecula [Endoscopy Only] — Temecula, California, United States
• Front Range Endoscopy Center — Colorado Springs, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test) — Clearwater, Florida, United States
• West Coast Endoscopy Center (Endoscopy Procedures) — Clearwater, Florida, United States
• Northwood Vision- Optical Coherence Tomography (OCT) — Clearwater, Florida, United States
• Northwood Vision-Optical Coherence Tomography-(OCT) — Clearwater, Florida, United States
• Safety Harbor Surgery (Endoscopy Facility) — Clearwater, Florida, United States
• Gastro Florida (Regulatory & Administrative Duties) — Clearwater, Florida, United States
• Center for Digestive Health (Colonoscopy Location) — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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