ABX464 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+257 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Abivax S.A.

Must not be taking: Antidiarrheals, Probiotics

Disqualifiers: Proctitis, Sclerosing cholangitis, Hepatitis, others

Pivotal Trial (Near Approval)

Prior Safety Data

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 does not specify if you must stop taking your current medications, but it mentions a 'washout period' (time without taking certain medications) before the screening endoscopy. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

This trial is for men and women at least 16 years old with moderate to severe ulcerative colitis who haven't responded well or are intolerant to certain therapies like corticosteroids, immunosuppressants, biologics, S1P receptor modulators, or JAK inhibitors. Participants must have a confirmed diagnosis of UC for over 90 days and active disease. They should agree to use effective contraception if applicable.

Inclusion Criteria

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

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

I have not responded well to treatments like steroids, immunosuppressants, or biologics.

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Exclusion Criteria

I am currently taking medication for diarrhea.

Pregnant or breast-feeding women.

Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period: Hemoglobin ≤ 8.0 g dL-1, Absolute neutrophil count < 750 mm-3, Platelets < 100,000 mm-3, Creatinine clearance < 50 mL.min-1 (Cockroft-Gault formula), Total serum bilirubin > 1.5 x ULN, Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN

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Trial 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 (Anti-inflammatory)

Trial OverviewABTECT-1 is testing the effectiveness and safety of ABX464 in doses of either 25 mg or 50 mg daily compared to a placebo in achieving clinical remission in patients with ulcerative colitis. The study randomly assigns participants to receive either ABX464 or a placebo alongside their standard treatments.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ABX464 50mgExperimental Treatment1 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 25mgExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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