NCT07686081RecruitingPhase 3
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
Vanda Pharmaceuticals4 sites in 1 country150 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- Clinical Remission at Week 16
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Ponesimod (VSP-128)
Experimental
Intervention: Ponesimod (Drug)
Outcomes
Primary Outcomes
Clinical Remission at Week 16
Time Frame: Week 16
Proportion of participants achieving clinical remission at Week 16.
Secondary Outcomes
- Clinical Response at Week 16(Week 16)
- Endoscopic Improvement at Week 16(Week 16)
- Symptomatic Remission at Week 16(Week 16)
- Change From Baseline in Mayo Score at Week 16(Baseline to Week 16.)
Investigators
Study Sites (4)
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