CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
ABX464 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 weeks prior to screening, with Mayo Clinic Score 6-12 at prior diagnosis and centrally-read endoscopy score ≥2 at screening
  • ✓Prior failure or intolerance to anti-TNFα therapy (must be discontinued ≥8 weeks before baseline)
  • ✓Prior failure or intolerance to vedolizumab (must be discontinued ≥8 weeks before baseline)
  • ✓If on oral corticosteroids, must be on stable dose of prednisone ≤20 mg/day (or equivalent) for ≥2 weeks before baseline
Key exclusion· 5
  • ✕Diagnosis of Crohn's Disease, indeterminate colitis, or history/presence of fistula with CD
  • ✕History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, stoma, or colectomy risk
  • ✕History or current colonic dysplasia or adenomatous colonic polyps
  • ✕Severe gastrointestinal complications including short bowel syndrome, obstructing strictures, recent/planned bowel surgery, ileostomy, colostomy, or recent bowel perforation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093259
NCT03093259Phase 2Completed
CompareCT.gov

Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFα, Vedolizumab and/or Corticosteroids

Abivax S.A.·interventional·Posted Mar 28, 2017·Updated Jun 3, 2024

In Brief

A Phase 2 clinical trial evaluating ABX464 and Placebo oral capsule for Ulcerative Colitis. Completed, enrolled 32 participants across 19 sites in 8 countries.

Detailed Summary

This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustria, Belgium, Czechia, France, Germany, Hungary, Poland, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartNov 16, 2017
Primary CompletionJul 25, 2018
Study CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

ABX464drug

ABX464 is a new Anti-inflammatory drug

Placebo oral capsuledrug

Placebo matching with ABX464