Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Key facts

Study ID

NCT04607837

Run by

Pfizer

People needed

234

Starts

2021-04-12

Expected to finish

2024-06-19

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
• Active UC confirmed by endoscopy
• Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
• Received a surveillance colonoscopy within 12 months before baseline

You may not qualify if…

• Severe extensive colitis
• Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
• Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
• Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

Where it is running

• Digestive Health Specialists — Dothan, Alabama, United States
• Dothan Eyecare-Dr. Brent McKinley (OCT Location) — Dothan, Alabama, United States
• Pulmonary Associates (Secondary PFT Location) — Dothan, Alabama, United States
• Flowers Hospital (PFT Location) — Dothan, Alabama, United States
• Arizona Retina Institute/ Phoenix Retina Associates(OCT) — Peoria, Arizona, United States
• SimonMed Imaging (Imaging) — Peoria, Arizona, United States
• Sun City Endoscopy (Endoscopy) — Sun City, Arizona, United States
• Euclid Endoscopy Center-El Cajon (Endoscopy procedure only) — El Cajon, California, United States
• Center for Clinical Research (CCR) — Irvine, California, United States
• UCI Gavin Herbert Eye Institute — Irvine, California, United States
• UCI Gottschalk Medical Plaza — Irvine, California, United States
• Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only) — La Mesa, California, United States
• Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only) — La Mesa, California, United States
• Advanced Endoscopy and Pain Center (Colonoscopy) — Lancaster, California, United States
• Advanced Imaging Center (Chest X-Ray) — Lancaster, California, United States
• Antelope Valley Eye Care (Ophthalmologist) — Lancaster, California, United States
• AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review) — Lancaster, California, United States
• Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review) — Lancaster, California, United States
• OM Research LLC — Lancaster, California, United States
• Abraham M. lshaaya MD (X-Ray) — Los Angeles, California, United States
• Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory, — Los Angeles, California, United States
• Advanced Vision Care (OCT) — Los Angeles, California, United States
• Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist) — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC — Los Angeles, California, United States
• Center for Digestive Health (Colonoscopy Location) — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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