Research & Development

Explore Our Clinical Trials

Obefazimod is currently being tested in Phase 3 trials (ABTECT program) in patients with moderately to severely active ulcerative colitis (UC) and a Phase 2b trial (ENHANCE-CD) for moderately to severely active Crohn’s disease (CD).

Active Clinical Trials

Phase 3 Program in UC—ABTECT

ABTECT-1

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Obefazimod (ABX464) Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Estimated Enrollment: N=612
Started 2022

ABTECT-2

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Obefazimod (ABX464) Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Estimated Enrollment: N=612
Started 2022

ABTECT MAINTENANCE

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of Obefazimod (ABX464) 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Estimated Enrollment: N=1050
Started 2023

Phase 2 Trial in UC

A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of Obefazimod (ABX464) Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis

Estimated Enrollment: N=203
Started 2021

Phase 2b Trial in CD—ENHANCE-CD

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

Estimated Enrollment: N=212
Started 2024

Completed Phase 2 Trials

Phase 2 Trials in UC

Phase IIa Study to Evaluate the Safety and Efficacy of Obefazimod (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

Actual Enrollment: N=32
Completed 2019

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of Obefazimod (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

Actual Enrollment: N=254
Completed 2021

A Phase 2b, Open-label, Efficacy and Safety Study of Obefazimod (ABX464) (50 mg) as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Actual Enrollment: N=217
Completed 2024