RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
Vanda Pharmaceuticals · NCT07686081
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 150
- US sites recruiting
- 2
- Study start
- September 2026
- Record last updated
- August 18, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: Ponesimod; Placebo
Conditions: Ulcerative Colitis (UC)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Vanda Investigational Site
Chula Vista, CA 91910
Vanda Investigational Site
Nashville, TN 37211
Study contacts (from the official record)
- Vanda Pharmaceuticals Inc. · 202-734-3400 · clinicaltrials@vandapharma.com