A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction
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Clinical Trial Information
Trial Contact: Shepherd, Adriane R; Garcia de Djuro, Ginette
Trial Phone: 321 841-2285 ; 321.841.6649
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IRB No: WIRB45564335
Protocol Abbrev: ABX464-105
Principal Investigator: Udayakumar Navaneethan, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: ABX464-105
Treatment: Drug: ABX464 Drug: Placebo
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05507203
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Objective
The primary objective is to compare the efficacy of ABX464 versus placebo on clinical remission.
o Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8. -
Key Eligibility
Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weight ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
Documented diagnosis of UC > 90 days prior to baseline, confirmed by endoscopy and histology. Should histology results not be available at screening, results from biopsies taken at screening may be used.
Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA is not accepted).
Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods
Subjects able and willing to comply with study visits and procedures as per protocol.
Subjects should be affiliated to a health insurance policy whenever required by a participating country or state
