Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Ulcerative Colitis
Age (in years)
18 - 80
Phase
Phase 2
Participants needed
235
Est. Completion Date
Jul 24, 2024
Treatment type
Interventional
Sponsor
Pfizer
ClinicalTrials.gov identifier
NCT04607837
Study number
APD334-210
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?