A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO)
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO)
ClinicalTrials.gov ID: NCT05528510
Sponsor: Janssen Research & Development, LLC
Information provided by: Janssen Research & Development, LLC (Responsible Party)
Last Update Posted: 2023-09-13
Brief Summary:
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Detailed Description:
UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks.
OFFICIAL TITLE
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
INTERVENTION / TREATMENT
Drug: Guselkumab Dose 1
Drug: Guselkumab Dose 2
Drug: Guselkumab Dose 3
Other: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-09-13
|
| Primary Completion (Estimated) | 2024-05-17 |
| Study Completion (Estimated) | 2026-05-04 |
| Enrollment (Estimated) | 400 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CR109228
2022-000365-41 (EudraCT Number)
CNTO1959UCO3004 (Other Identifier) (OTHER: Janssen Research & Development, LLC)
|