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ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03093259
Recruitment Status : Active, not recruiting
First Posted : March 28, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: ABX464 Drug: Placebo oral capsule Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind Treatment
Primary Purpose: Treatment
Official Title: Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFα, Vedolizumab and/or Corticosteroids
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABX464 Treatment Arm
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
Drug: ABX464
ABX464 is a new Anti-inflammatory drug

Placebo Comparator: ABX464 matching placebo Treatment Arm
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Drug: Placebo oral capsule
Placebo matching with ABX464




Primary Outcome Measures :
  1. Number of incidences of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 12 weeks ]
    Number of incidences of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo


Secondary Outcome Measures :
  1. IL-22 expression levels [ Time Frame: Week 4 and Week 8 ]
    Change from baseline in IL-22 expression levels (transcriptome) in serum and rectal/sigmoidal tissue compared to placebo

  2. MicroRNA-124 levels [ Time Frame: Week 4 and Week 8 ]
    Change from baseline in microRNA-124 levels in whole blood (PAXgene®) compared to placebo.

  3. Total Mayo Score [ Time Frame: Week 4 and Week 8 ]
    Change from baseline in Total Mayo Score in subjects receiving ABX464 compared to placebo

  4. Clinical Remission according to the Total Mayo Score [ Time Frame: Week 4 and Week 8 ]
    Proportion of subjects receiving ABX464 with clinical remission according to the Total Mayo Score compared to placebo. Remission exclude friability and is based on total Mayo score ≤ 2 with no individual sub-score > 1



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093259


Locations
Belgium
University Hospitals Leuven - campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Abivax S.A.
Investigators
Study Director: Paul GINESTE Abivax S.A.

Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT03093259     History of Changes
Other Study ID Numbers: ABX464-101
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abivax S.A.:
ABX464
Ulcerative Colitis
Refractory

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases