QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS12010, Placebo.
- Who it may be relevant to
- Registry conditions: Adults With Moderate-to-severe Hidradenitis Suppurativa. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug QLS12010
QLS12010 oral capsules - Drug Placebo
Matching placebo oral capsules
Primary outcome measures
- Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B] [Time frame: Week 16]
- Incidence and severity of treatment emergent Adverse Events [Part A] [Time frame: up to approximately 24 weeks]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07417917 · QLS12010-202