ABX464-107 (ABTECT - Maintenance)
Research type
Research Study
Full 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 a maintenance therapy in subjects with moderately to severely active ulcerative colitis.
IRAS ID
1006251
Contact name
Anais Vissian
Contact email
Sponsor organisation
ABIVAX SA
Clinicaltrials.gov Identifier
Research summary
This study is a phase 3, randomised, double-blind, placebo-controlled study. The purpose of this study is to look at whether the study drug, ABX464, is safe and can help patients with moderate to severely active ulcerative colitis (UC) when given over a long period of time. Patients previously enrolled in the ABTECT 1 (ABX464-105) and ABTECT 2 (ABX464-106) studies, will have the option to rollover into this maintenance extension study.
The study is being carried out at multiple centres globally and across the UK and aims to recruit approximately 1100 patients.
This study is made up of 2 periods:
• Maintenance treatment period (44 weeks)
• Follow-up period (4 weeks after the last dose of the study medication)
This maintenance study is divided into 2 parts, and participants will be assigned study treatment based on if their UC responded to the study treatment in the main studies.
Part 1 – Responders
Participants who had a response to the study treatment in the induction studies, Eligible patients will be randomly assigned to 1 of 3 study treatment groups to receive one of the following:
- Study Drug at 25mg per dose
- Study Drug at 50mg per dose
- Placebo
Part 1 of this study is “double-blind”, which means neither the participant nor the study doctor knows which participants receive the study drug (or at which dose) and which receive placebo.
Part 2 – Non-Responders
Participants who need no show response to the study treatment in the induction studies will be randomly assigned to receive one of the following:
- Study Drug at 25mg per dose
- Study Drug at 50mg per dose
Part 2 of this study is “open-label”, which means both participants and the study doctor know which dose of the study drug participants receive.
The study medication comes in the form of a capsule that is taken orally (by mouth).
The total study duration for a complete duration of study participation is up to 48 weeks.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0401
Date of REC Opinion
5 Dec 2022
REC opinion
Further Information Favourable Opinion