A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male and female subjects aged 18-75 years
• Able to provide written informed consent
• Diagnosis of ulcerative colitis for ≥90 days prior to screening
• Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1
• History of inadequate response, loss of response, or intolerance to at least one approved UC therapy
Locations
United States
California
Vanda Investigational Site
RECRUITING
Chula Vista
Tennessee
Vanda Investigational Site
RECRUITING
Nashville
Contact Information
Primary
Vanda Pharmaceuticals Inc.
clinicaltrials@vandapharma.com
202-734-3400
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2029-08
Participants
Target number of participants: 150
Treatments
Experimental: Ponesimod (VSP-128)
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Vanda Pharmaceuticals