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NOT YET RECRUITING
NCT06932003
PHASE1/PHASE2

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

Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-04-15

Completion Date

2025-12-30

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DRUG

LT-002-158 Tablets

The subjects will orally administered LT-002-158 tablets once a day.