ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
ClinicalTrials.gov ID: NCT05507203
Sponsor: Abivax S.A.
Information provided by: Abivax S.A. (Responsible Party)
Last Update Posted: 2023-08-31
Brief Summary:
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].
OFFICIAL TITLE
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
INTERVENTION / TREATMENT
Drug: ABX464
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-10-10 |
| Primary Completion (Estimated) |
2024-05
|
| Study Completion (Estimated) | 2024-06 |
| Enrollment (Estimated) | 612 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ABX464-105
|