ABX464 for Ulcerative Colitis

Recruiting at 275 trial locations

Overseen By John Hong, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Abivax S.A.

Must not be taking: Antidiarrheals, Probiotics

Disqualifiers: Proctitis, Hepatitis, Heart disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

612 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions a 'washout period' requirement before the screening endoscopy. This suggests that you might need to stop certain medications before participating. Please consult with the trial team for specific guidance.

Research Team

Severine Vermeire, MD, PhD

Principal Investigator

UZ Leuven, Belgium

Bruce Sands, MD, PhD

Principal Investigator

Mount Sinai Health System Digestive Disease Institute, New York USA

Eligibility Criteria

This trial is for men and women at least 16 years old with ulcerative colitis (UC) that's moderately to severely active. They should have tried other UC treatments like corticosteroids, immunosuppressants, or biologics without success or couldn't tolerate them. Participants need to understand the study and consent to it, use effective birth control if necessary, and be able to follow the study schedule.

Inclusion Criteria

Subjects should be affiliated to a health insurance policy whenever required by a participating country or state

Subjects able and willing to comply with study visits and procedures as per protocol.

I am using or willing to use effective birth control methods.

Exclusion Criteria

I have tried 5-ASA therapy for my condition without success.

I have hepatitis B.

Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABX464 or placebo daily for 8 weeks to evaluate efficacy and safety in inducing clinical remission

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ABX464

Trial Overview ABTECT-2 is testing ABX464 at doses of 25 or 50 mg daily against a placebo in people with UC who haven't responded well to standard therapies. The goal is to see if ABX464 can induce clinical remission. This multicenter trial randomly assigns participants into different groups in a controlled environment.

Participant Groups

Group I: ABX464 50mg Experimental Treatment 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Group II: ABX464 25mg Experimental Treatment 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Group III: Placebo Placebo Group 1 Intervention

Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks

Who Is Running the Clinical Trial?

Abivax S.A.

Lead Sponsor

Trials

22

Recruited

4,400+