Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis

NCT07686081 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VP-VSP-128-3201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Ulcerative Colitis (UC)

Keywords

ulcerative colitis; moderately to severely active ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Remission at Week 16

  Proportion of participants achieving clinical remission at Week 16.

  Week 16

Secondary Outcomes (4)

• Clinical Response at Week 16

  Week 16

• Change From Baseline in Mayo Score at Week 16

  Baseline to Week 16.

• Endoscopic Improvement at Week 16

  Week 16

• Symptomatic Remission at Week 16

  Week 16

Study Arms (2)

Ponesimod (VSP-128)

EXPERIMENTAL

Drug: Ponesimod

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ponesimod DRUG

Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.

Also known as: VSP-128

Ponesimod (VSP-128)

Placebo DRUG

Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (2)

Vanda Investigational Site

Chula Vista, California, 91910, United States

RECRUITING

Vanda Investigational Site

Nashville, Tennessee, 37211, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ponesimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400; clinicaltrials@vandapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)