A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis

Inclusion criteria

• . At least 18 years old and not more than 75 years old at the time of signing the Informed Consent Form (ICF), regardless of their sex.
• . Body mass index \[BMI = weight (kg)/height2(m2)\] ≥ 18 kg/m2 at screening.
• . Participants with active UC who have a modified 9-point Mayo score of 5 to 9 and an endoscopic subscore of 2 to 3 at baseline (the interval between screening endoscopy and baseline cannot exceed 14 days), with a rectal bleeding subscore of at least 1.
• . At the time of first dose, the participant is diagnosed with UC for at least 90 days, and UC is confirmed by investigation during the screening visit.
• . The investigator considers that the participant has an inadequate response, loss of response, or intolerance to conventional therapy (oral 5-ASA, immunomodulators, or corticosteroids), anti-tumor necrosis factor (TNF) or other biologic therapy, JAK inhibitor therapy, or is unable to receive these treatments for other reasons.
• . If the participant is currently receiving the following UC therapy at screening, a stable dosage should be administered within the specified time:
• . Oral 5-ASA (mesalazine) (with stable dosage at least 2 weeks before baseline and during the study treatment period), AND/OR
• . Oral corticosteroids (prednisone or prednisolone ≤ 20 mg/day) (with stable dosage for at least 2 weeks prior to baseline and during the treatment period). All other systemic corticosteroid routes are prohibited.

Exclusion criteria