Athos Therapeutics Inc
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.
The trial will consist of a 4-week screening period, a 12-week double-blind treatment period, and an open-label extension. Following completion of the 12-week double-blind period, participants who wish to continue into the open-label extension will be unblinded. Participants who do not wish to continue into the extension will remain blinded and proceed to posttreatment follow-up at Weeks 16 and 24 (via telephone calls). Unblinded participants who are revealed to have been randomized to receive ATH-063 will also proceed to posttreatment follow-up at Weeks 16 and 24 (via telephone calls). Unbli…
Inclusion Criteria: * 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 ho…
Three 50 mg capsules, total dose 150 mg.
Identical capsule to the drug without the active ingredient.
Arctuva estimate
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