The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory moderately to severely active UC.
Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent.
Male or female participants must be postmenopausal/surgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception, including 1 physical barrier method (condom or diaphragm) plus 1 highly effective method (ie, hormonal contraception., intrauterine device, intrauterine hormone-releasing system, bilateral occlusion, vasectomy, or complete sexual abstinence). Women of childbearing potential (WOCBP) must also be nonpregnant and not breastfeeding.
Has a diagnosis of UC confirmed by endoscopic and histologic evidence at least 4 months before screening. If confirmation is not available in source documentation, the screening endoscopy and histology reports for this trial may serve as evidence.
Clinically significant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening, that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of oral medicines (as judged by the investigator).
Hospitalization for exacerbation of UC requiring intravenous (IV) corticosteroids (ie, UC flare) within 12 weeks prior to screening.
Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation.
Parallel
ATH-063
DrugThree 50 mg capsules, total dose 150 mg.
Placebo
Other interventionIdentical capsule to the drug without the active ingredient.
Clinical Remission at Week 12
Clinical remission is defined as a ulcerative colitis disease severity score (UCDSS) of 0 to 2, including the following components: a stool frequency subscore (SFS) of 0 (on a scale from 0 to 3, with higher scores indicating higher frequency) or an SFS of 1 with a decrease of at least 1 point from baseline; a rectal bleeding subscore (RBS) of 0; and a centrally read endoscopic mucosal appearance (EMA) subscore of 0 or 1. The UCDSS (0 to 9 points) is the sum of the following 3 components: RBS (0 to 3), SFS (0 to 3), and EMA subscore (0 to 3), with higher scores indicating more severe disease.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Trial Discontinuation
Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes will be included as TEAEs.
Clinical Response at Week 12
Clinical response is defined as a decrease from baseline of ≥2 points and ≥30% in the UCDSS, plus either a decrease from baseline of ≥1 point in RBS (range 0 to 3, with higher scores denoting greater severity) or an absolute RBS of 0 or 1.
Change From Baseline in UCDSS at Week 12
The UCDSS (0 to 9 points) is the sum of the following 3 components: RBS (0 to 3), SFS (0 to 3), and EMA subscore (0 to 3), with higher scores indicating more severe disease.
Proportion of Participants Who Achieve FDA-defined Clinical remission at Week 12
Food and Drug Administration (FDA)-defined clinical remission is defined for purposes of this trial as a UCDSS of 0 to 2, including the following: an SFS of 0 or 1, an RBS of 0, and an EMA subscore of 0 or 1.
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