NCT07417917

QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa

A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II clinical study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of QLS12010 capsules in the treatment of moderate to severe Hidradenitis Suppurativa (HS). The study is comprised of two parts: Part A is a multi-center, open-label, single-dose group proof-of-concept study; Part B is a randomized, double-blind, placebo-controlled dose-ranging study. The overall duration of this study is up to 32 weeks, inclusive of the Screening Period, Treatment Period of up to 24 weeks, and the 4-Week Follow-Up Period for safety assessment.

Conditions

• Adults With Moderate-to-severe Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	QLS12010	QLS12010 oral capsules
DRUG	Placebo	Matching placebo oral capsules

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2028-05-01
• First posted: 2026-02-18
• Last updated: 2026-02-18