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;
Presence of >20 fistulas or deeply extensive coalescing lesions;
Other significant dermatological conditions that may interfere with efficacy evaluation or require concomitant treatment (e.g., seborrheic dermatitis), or any skin conditions deemed by investigators as potentially affecting study assessments (e.g., tattoos, scars);
Active tuberculosis;
Active hepatitis B/C, syphilis, or human immunodeficiency virus (HIV) infection;