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;
Single group
LT-002-158 Tablets
DrugThe subjects will orally administered LT-002-158 tablets once a day.
Incidence and severity of treatment emergent Adverse Events
Including adverse events (TEAEs) and serious adverse events that occurred during the study period; Clinically significant changes observed in laboratory tests, 12 lead electrocardiograms, vital signs, and physical examinations during the study period.
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Maximum observed plasma concentration (Cmax)
Time to maximum observed plasma concentration (Tmax)
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