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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: ABX464 Drug: Placebo oral capsule||Phase 2|
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|
|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|
|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|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Experimental: ABX464 Treatment Arm
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
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
- 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
- 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
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
|University Hospitals Leuven - campus Gasthuisberg|
|Leuven, Belgium, 3000|
|Study Director:||Paul GINESTE||Abivax S.A.|