Overview

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Status:
Completed
Trial end date:
2018-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abivax S.A.
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withdrawn ≥2 weeks before first dosing (i.e. baseline);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;