← Back to all trials
Recruiting
NCT07686081
Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
Conditions: Ulcerative Colitis (UC)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 150
Sponsor: Vanda Pharmaceuticals
Location: Vanda Investigational Site Chula Vista California
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Severe or fulminant UC likely to require hospitalization or surgery
* Diagnosis of Crohn's disease or other non-UC colitis
* Prior exposure to S1P receptor modulators
* Active or chronic infections
* Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease
* History of an allergic reaction or significant sensitivity to constituents of study drug
Source: ClinicalTrials.gov (NCT07686081). StuddyBuddy aggregates publicly available trial information.