Ulcerative colitis: ABTECT – Maintenance therapy

ClinicalTrials.gov ID: NCT05535946
Sponsor: Abivax S.A. Information provided by: Abivax S.A. (responsible party)

Official title:
A randomized, double-blind, multicenter Phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as maintenance therapy in patients with moderately to severely active ulcerative colitis.

Study overview:
Multicenter, randomized, placebo-controlled study to investigate the long-term efficacy and safety of ABX464 (50 mg and 25 mg, once daily) as maintenance therapy in patients with moderately to severely active ulcerative colitis who have responded inadequately, not at all, or no longer to conventional therapies or have not tolerated them (e.g., corticosteroids, immunosuppressants such as azathioprine, 6-mercaptopurine, methotrexate) and/or to advanced therapies (biologics such as TNF inhibitors, anti-integrins, anti-IL-23, S1P receptor modulators, and/or JAK inhibitors).

This study is the maintenance phase of the two previous induction studies ABX464-105 and ABX464-106.