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Trial record 1 of 1 for:    NCT03093259
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ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03093259
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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
  • MicroRNA-124 levels [ Time Frame: Week 4 and Week 8 ]
    Change from baseline in microRNA-124 levels in whole blood (PAXgene®) compared to placebo.
  • Total Mayo Score [ Time Frame: Week 4 and Week 8 ]
    Change from baseline in Total Mayo Score in subjects receiving ABX464 compared to placebo
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: ABX464
    ABX464 is a new Anti-inflammatory drug
  • Drug: Placebo oral capsule
    Placebo matching with ABX464
Study Arms  ICMJE
  • Experimental: ABX464 Treatment Arm
    Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
    Intervention: Drug: ABX464
  • Placebo Comparator: ABX464 matching placebo Treatment Arm
    Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
30
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093259
Other Study ID Numbers  ICMJE ABX464-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abivax S.A.
Study Sponsor  ICMJE Abivax S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul GINESTE Abivax S.A.
PRS Account Abivax S.A.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP