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

ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVanda Pharmaceuticals

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Ponesimod (VSP-128)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Remission at Week 16

Proportion of participants achieving clinical remission at Week 16.

Time frame
Week 16

Secondary outcomes

1

Clinical Response at Week 16

Proportion of participants achieving clinical response at Week 16.

Time frame
Week 16
2

Change From Baseline in Mayo Score at Week 16

Change from baseline in the three-component Mayo Score at Week 16. The overall score value ranges from 0 to 9, with higher scores indicating more severe ulcerative colitis disease activity.

Time frame
Baseline to Week 16.
3

Endoscopic Improvement at Week 16

Proportion of participants achieving endoscopic improvement at Week 16.

Time frame
Week 16
4

Symptomatic Remission at Week 16

Proportion of participants achieving symptomatic remission at Week 16.

Time frame
Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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