ABTECT-2 – ABX464 Treatment Evaluation for ulcerative Colitis Therapy -2

• Research type

  Research Study

• Full 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 (ABTECT-2 - ABX464 Treatment Evaluation for ulcerative Colitis Therapy -2)

• IRAS ID

  1006330

• Contact name

  Anais Vissian

• Contact email

  anais.vissian@abivax.com

• Sponsor organisation

  ABIVAX SA

• Clinicaltrials.gov Identifier

  NCT05507216

• Research summary

  This study is a phase 3, randomised, double-blind, placebo-controlled. 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).
  UC is a life-long condition that causes inflammation (pain, swelling) of the colon (part of the bowel or large intestine) due to an over-reaction of the immune system.
  Currently available treatments may help improve symptoms of UC for some patients, but not for others. Also, for some patients, existing treatments may help at first,
  but the symptoms may return. The study drug being looked at in this study is designed to work in a different way than the existing UC therapies.
  The study is being carried out at multiple centres globally and across the UK and aims to recruit approximately 612 patients.
  The study will consist of 3 periods:
  • Screening period (up to 4 weeks)
  • Treatment period (8 weeks)
  • Follow-up Period (4 weeks after last dose of study medication)
  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
  A placebo looks like the study drug but contains no active medication. It is used to help determine if the results of the study are due to the study drug or due to
  something else.
  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 16 weeks for patients not taking part to the maintenance study (ABX464-107).
  The Sponsor of the study is Abivax.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  22/LO/0733

• Date of REC Opinion

  6 Feb 2023

• REC opinion

  Further Information Favourable Opinion