ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT03093259 | Completed Phase 2 Results DMC

• 1 other identifier: ABX464-101
• Study Type: interventional
• Target: 32
• Locations: 8 countries
• Sites: 19

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.

Conditions

Ulcerative Colitis

Keywords

ABX464; Ulcerative Colitis; Refractory

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events

  Number of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo

  Week 8

Secondary Outcomes (4)

• Clinical Remission

  Week 8

• Fecal Calprotectin

  Week 8

• Total Mayo Score

  Week 8

• Change in Partial Mayo Score

  Week 8

Study Arms (2)

ABX464 Treatment Arm

EXPERIMENTAL

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

Drug: ABX464

ABX464 matching placebo Treatment Arm

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

ABX464 DRUG

ABX464 is a new Anti-inflammatory drug

ABX464 Treatment Arm

Placebo oral capsule DRUG

Placebo matching with ABX464

ABX464 matching placebo Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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• Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn ≥2 weeks before first dosing (i.e. baseline);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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (19)

Univ.-Klinik für Innere Medizin I

Innsbruck, 6020, Austria

Location

University Hospitals Leuven - campus Gasthuisberg

Leuven, 3000, Belgium

Location

Klinické centrum ISCARE

Prague, 17004, Czechia

Location

Orlicko-ustecka nemocnice

Ústí nad Orlicí, 56218, Czechia

Location

CHRU de Lille

Lille, 59037, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06202, France

Location

CHU Saint Etienne - CHU Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie

Berlin, 12200, Germany

Location

Akademisches Lehrkrankenhaus Christian-Albrechts-Universität zu Kiel

Hamburg, 22559, Germany

Location

DRC Gyógyszervizsgáló Központ Kft

Balatonfüred, H-8230, Hungary

Location

Belgyógyászati Klinika

Budapest, H-1088, Hungary

Location

Vasútegészségügyi Nonprofit Közhasznú Kft.,

Debrecen, H-4025, Hungary

Location

Centrum Badań

Lodz, 90302, Poland

Location

KO-Med

Lublin, Poland

Location

Medpolonia Poznań

Poznan, 60693, Poland

Location

NZOZ ViVamed

Warsaw, 03-580, Poland

Location

Centrum Badań Klinicznych Lekarze Sp.p

Wroclaw, 51-161, Poland

Location

Hospital RAMÓN Y CAJAL

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ABX464

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Sharon Skare
• Organization: Abivax

sharon.skare@abivax.com

+33 (0) 1 53 83 08 41

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind Treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized study

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 28, 2017
• Study Start: November 16, 2017
• Primary Completion: July 25, 2018
• Study Completion: February 4, 2019
• Last Updated: June 3, 2024
• Results First Posted: February 8, 2023

Record last verified: 2022-05

Locations

AU (1); HU (3); PL (5); BE (1); ES (1); FR (4); DE (2); CZ (2)