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QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
Official title: A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-04-01
Completion Date
2028-05
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
QLS12010
QLS12010 oral capsules
Placebo
Matching placebo oral capsules