ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT ID: NCT03093259

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2019-02-04

Brief 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.

Detailed Description

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.

Eligible subjects will be randomized according to a 2/1 ratio in two different groups of treatment. Randomized subjects who will receive 50 mg ABX464 orally once daily for 56 days.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ABX464 Treatment Arm

Subjects will receive 50 mg of ABX464 orally once daily for 56 days.

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

ABX464 is a new Anti-inflammatory drug

ABX464 matching placebo Treatment Arm

Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo matching with ABX464

Interventions

ABX464

ABX464 is a new Anti-inflammatory drug

Intervention Type: DRUG

Placebo oral capsule

Placebo matching with ABX464

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 weeks prior to screening visit. Moderate to severe active UC defined by Mayo Clinic Score (MCS) of 6 to 12 inclusive (on a scale of 0-12). Moderate to severe active UC should be confirmed at screening visit with a centrally read MCS endoscopy score of at least 2 (on a scale of 0-3);
• Subjects receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent ≤20 mg/day) or on beclomethasone diproprionate (≤5mg/day) or on budesonide MMX (≤9mg/day), for ≥2 weeks before first dosing (i.e. baseline);
• Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn ≥2 weeks before first dosing (i.e. baseline);
• Subjects who are on oral 5-aminosalicylic acid must have been on a stable dose ≥4 weeks before first dosing (i.e. baseline);
• Subjects who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for 4 weeks before first dosing (i.e. baseline). Subjects taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
• Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii) must be on stable doses for 2 weeks before first dosing (i.e. baseline);
• Subjects on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for 2 weeks before first dosing (i.e. baseline);
• Subjects who have previously received anti-tumor necrosis factor (TNF) therapy or vedolizumab must have discontinued therapy ≥8 weeks before first dosing (i.e. baseline);
• Subjects previously treated with cyclosporine or tacrolimus must have discontinued therapy ≥4 weeks before first dosing (i.e. baseline);
• Subjects previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 weeks before first dosing (i.e. baseline).

Exclusion Criteria

• Subject with Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD;
• History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy;
• History or current evidence of colonic dysplasia or adenomatous colonic polyps. Subject with severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
• Subject with significant and known active infections at screening such as Infected abscess, positive for Clostridium difficile (stool antigen and toxin), CMV, TB and recent infectious hospitalization;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univ.-Klinik für Innere Medizin I

Innsbruck, , Austria

University Hospitals Leuven - campus Gasthuisberg

Leuven, , Belgium

Klinické centrum ISCARE

Prague, , Czechia

Orlicko-ustecka nemocnice

Ústí nad Orlicí, , Czechia

CHRU de Lille

Lille, , France

CHU de Nantes

Nantes, , France

CHU de Nice

Nice, , France

CHU Saint Etienne - CHU Hopital Nord

Saint-Priest-en-Jarez, , France

Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie

Berlin, , Germany

Akademisches Lehrkrankenhaus Christian-Albrechts-Universität zu Kiel

Hamburg, , Germany

DRC Gyógyszervizsgáló Központ Kft

Balatonfüred, , Hungary

Belgyógyászati Klinika

Budapest, , Hungary

Vasútegészségügyi Nonprofit Közhasznú Kft.,

Debrecen, , Hungary

Centrum Badań

Lodz, , Poland

KO-Med

Lublin, , Poland

Medpolonia Poznań

Poznan, , Poland

NZOZ ViVamed

Warsaw, , Poland

Centrum Badań Klinicznych Lekarze Sp.p

Wroclaw, , Poland

Hospital RAMÓN Y CAJAL

Madrid, , Spain

Countries

Austria; Belgium; Czechia; France; Germany; Hungary; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABX464-101

Identifier Type: -

Identifier Source: org_study_id