Adults With Moderate-to-severe Hidradenitis Suppurativa
Conditions
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.
Interventions
DRUGQLS12010
QLS12010 oral capsules
DRUGPlacebo
Matching placebo oral capsules
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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: 1. Regular systemic antibiotic treatment for HS has been ineffective. 2. 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B] | Week 16 |
| Incidence and severity of treatment emergent Adverse Events [Part A] | up to approximately 24 weeks |
Contacts
CONTACTHang Li, M.D.
CONTACTPanpan Shang, M.D.
Outcome results
None listed