drugset / Trial / NCT06932003

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa

NCT06932003 ↗

Phase 1/2 Not yet recruiting 12 enrolled Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-04-15
Primary completion
2025-10-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject LT-002-158 Other / unclassified — Oral