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.