NCT03760003

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

Detailed description

This phase 2b study will evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in improving Modified Mayo Score (MMS) in patients with moderate to severe Ulcerative Colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha \[TNF-α\] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment . Eligible patients will be randomized into 4 parallel intervention/treatment groups: 100mg q.d of ABX464, 50mg q.d of ABX464, 25mg q.d of ABX464, or matching placebo and will be treated for 16 weeks.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ABX464 100 mg	ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
DRUG	ABX464 50 mg	ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
DRUG	ABX464 25 mg	ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
DRUG	Placebo	Two capsules of placebo once daily for 16 weeks

Timeline

• Start date: 2019-08-13
• Primary completion: 2021-04-01
• Completion: 2021-04-16
• First posted: 2018-11-30
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

130 sites across 17 countries: United States, Austria, Belarus, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study