Ulcerative Colitis (UC)
Conditions
Keywords
ulcerative colitis, moderately to severely active ulcerative colitis
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
Interventions
DRUGPonesimod
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.
DRUGPlacebo
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.
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission at Week 16 | Week 16 | Proportion of participants achieving clinical remission at Week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Week 16 | Week 16 | Proportion of participants achieving clinical response at Week 16. |
| Change From Baseline in Mayo Score at Week 16 | Baseline to Week 16. | Change from baseline in Mayo score at Week 16. |
| Endoscopic Improvement at Week 16 | Week 16 | Proportion of participants achieving endoscopic improvement at Week 16. |
| Symptomatic Remission at Week 16 | Week 16 | Proportion of participants achieving symptomatic remission at Week 16. |
Countries
United States
Contacts
CONTACTVanda Pharmaceuticals Inc.
Outcome results
None listed