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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
ABX464 is a new Anti-inflammatory drug
Placebo matching with ABX464
Univ.-Klinik für Innere Medizin I
Innsbruck, Austria
University Hospitals Leuven - campus Gasthuisberg
Leuven, Belgium
Number of Subjects With Treatment-emergent Adverse Events
Number of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo
Time frame: Week 8
Clinical Remission
Percentage of subjects receiving ABX464 with clinical remission according to the Total Mayo Score at Week 8 compared to placebo (primary efficacy endpoint)
Time frame: Week 8
Fecal Calprotectin
Percentage of patients with fecal calprotectin levels \> 50µg/g at Week 8 compared to placebo
Time frame: Week 8
Total Mayo Score
Change from baseline in Total Mayo Score in subjects receiving ABX464 compared to placebo. The scale ranges from 0 to 12; 12 being the worst score) - 4-component Scale: Rectal bleeding, Stool frequency, Mucosal appearance and Physician Global Assessment
Time frame: Week 8
Change in Partial Mayo Score
Change from baseline in Partial Mayo Score in subjects receiving ABX464 compared to placebo. The scale ranges from 0 to 9, with 9 indicating the worst score. It is a three-component scale assessing rectal bleeding, stool frequency, and the physician's global assessment.
Time frame: Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinické centrum ISCARE
Prague, Czechia
Orlicko-ustecka nemocnice
Ústí nad Orlicí, Czechia
CHRU de Lille
Lille, France
CHU de Nantes
Nantes, France
CHU de Nice
Nice, France
CHU Saint Etienne - CHU Hopital Nord
Saint-Priest-en-Jarez, France
Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie
Berlin, Germany
Akademisches Lehrkrankenhaus Christian-Albrechts-Universität zu Kiel
Hamburg, Germany
...and 9 more locations