A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Key facts

Study ID

NCT04173273

Run by

Pfizer

People needed

379

Starts

2020-01-06

Expected to finish

2025-06-09

Last updated by the study team

2026-07-01

Who can join

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

You may qualify if…

• Men or women 18 to 80 years of age,
• Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
• Diagnosed with Crohn's disease (CD) ≥ 3 months
• Have moderately to severely active CD at Screening
• Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:
• Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
• Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
• Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
• Integrin receptor antagonist (eg, vedolizumab)
• Interleukin -12/-23 antagonist (eg, ustekinumab)
• Females of childbearing potential must be nonpregnant
• Females of childbearing potential and males must use contraception

You may not qualify if…

• History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
• Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
• Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
• Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
• Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
• Have an ileostomy or a colostomy.
• Inclusion Criteria for Substudy 3:
• Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit
• Inclusion Criteria for Substudy 4:
• Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Where it is running

• Digestive Health Specialists — Dothan, Alabama, United States
• Dothan Eyecare-Dr. Brent McKinley (OCT Location) — Dothan, Alabama, United States
• Pulmonary Associates (PFT Location) — Dothan, Alabama, United States
• Flowers Hospital (Imaging Location) — Dothan, Alabama, United States
• Digestive Health Specialists (Satellite Clinic Location) — Mobile, Alabama, United States
• Premier Medical Group East (Opthalmology & Optometry Facility) — Mobile, Alabama, United States
• Pulmonary Associates (Chest X-Ray & PFT Facility) — Mobile, Alabama, United States
• Surgicare of Mobile (Endoscopy & Biopsy Facility) — Mobile, Alabama, United States
• Arizona Retina Institute/ Phoenix Retina Associates(OCT) — Peoria, Arizona, United States
• SimonMed Imaging (Imaging) — Peoria, Arizona, United States
• Sun City Endoscopy Center (Endoscopy) — Sun City, Arizona, United States
• Om Research LLC — Apple Valley, California, United States
• Victor Valley Advanced Imaging — Apple Valley, California, United States
• Koman Family Outpatient Pavilion (ENDO) — La Jolla, California, United States
• Perlman Medical Offices — La Jolla, California, United States
• UCSD Clinical and Translational Research Institute — La Jolla, California, United States
• UCSD Health System (Endo/PFT/DLCO) — La Jolla, California, United States
• UCSD lnvestigational Drug Service Pharmacy — La Jolla, California, United States
• Shiley Eye Institute (OCT) — La Jolla, California, United States
• A V Pediatrics, Allergy and Family Medicine - PFT — Lancaster, 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 — Lancaster, California, United States
• Center for Digestive Health (Endoscopy Location) — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.