A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 102
- Primary Endpoint
- Incidence and severity of treatment emergent Adverse Events [Part A]
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At screening, the diagnosis of Hidradenitis suppurativa (HS), with a duration of HS ≥ 6 months;
- •Have moderately to severely active HS at Screening and baseline
- •According to the assessment of the Investigators, one of the following medical histories exists:
- •Regular systemic antibiotic treatment for HS has been ineffective.
- •The patient is intolerant to or has contraindications for systemic antibiotic treatment for HS.
Exclusion Criteria
- •Participants has a fistulas/sinus tracts (active and inactive) \>20 at Screening or Baseline；
- •History of severe cardiovascular and cerebrovascular diseases occurring within 6 months prior to screening, including but not limited to unstable angina pectoris, New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, cardiomyopathy, cerebral hemorrhage, acute cerebral infarction, etc.;
- •Participants with a history of prior use of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) degraders, small-molecule IRAK4 inhibitors, or similar agents;
- •Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening;
- •Pregnant or lactating women, or participants with a positive pregnancy test result at screening;
Arms & Interventions
QLS12010 Capsule Dose 1 Group
Intervention: QLS12010 (Drug)
QLS12010 Capsule Dose 2 Group
Intervention: QLS12010 (Drug)
Placebo Group
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence and severity of treatment emergent Adverse Events [Part A]
Time Frame: up to approximately 24 weeks
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]
Time Frame: Week 16
Secondary Outcomes
No secondary outcomes reported