A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa
This study is a Phase Ic/II clinical trial conducted in Chinese patients with moderate-to-severe hidradenitis suppurativa (HS), aiming to evaluate the safety and efficacy of LT-002-158 tablets in the treatment of moderate-to-severe HS. The study consists of two parts. The Phase Ic portion employs an open-label, single-arm design to primarily investigate the safety and tolerability of LT-002-158 tablets in patients with moderate-to-severe HS. The Phase II study adopts a randomized, double-blind, placebo-controlled, parallel-group design, with an open-label, single-arm extension phase, to primarily assess the therapeutic efficacy of LT-002-158 tablets in patients with moderate-to-severe HS.
• Male or female aged 18 to 75 years (inclusive), with body mass index (BMI) between 17.5 and 40.0 kg/m² (inclusive) and body weight ≥45.0 kg;
• Diagnosis of hidradenitis suppurativa (HS) with disease duration of at least 6 months prior to enrollment;
• Have inadequate response or intolerance to prior HS treatments and are suitable candidates for this study on investigator's judgment;
• Total count of abscesses and inflammatory nodules ≥4 at baseline;
• No pregnancy plans during the study and for 6 months after the last dose, with agreement to use effective contraception methods;
• Understand and voluntarily sign the informed consent form; Willing and able to to complete patient diary entries as required by the protocol;
• The subject is willing and able to comply with all protocol requirements by investigator's judgment.