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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Oct 30, 2025 → Oct 30, 2028
See other at-risk trials from Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

Record History

  1. Primary completion pushed from Oct 30, 2025 to Oct 30, 2028 Recruitment opened · Completion pushed from Dec 30, 2025 to Dec 30, 2028 · Study sites: 0 to 1 · 1 morev2 Show 4 more changesShow less
    • Recruitment opened
    • Completion pushed from Dec 30, 2025 to Dec 30, 2028
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 15, 2025 to Jul 8, 2025
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06932003
Lead Sponsor Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Conditions Hidradenitis Suppurativa (HS)
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov