Moderate-to-severe Atopic Dermatitis
Conditions
Brief summary
This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.
Interventions
DRUGQLS12010
QLS12010 oral capsule
DRUGPlacebo
Matching placebo oral capsule
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
1. At screening, the diagnosis of atopic dermatitis (AD) shall meet the Hanifin-Rajka criteria, with a duration of AD ≥ 1 year prior to baseline; 2. At screening and baseline: Eczema Area and Severity Index (EASI) score ≥ 16 points, Investigator's Global Assessment (IGA) score ≥ 3 points, and body surface area (BSA) affected by AD ≥ 10%; 3. At baseline: Weekly mean score of Pruritus Numerical Rating Scale (PP NRS) ≥ 4 points (with daily PP NRS scores recorded on at least 4 days within the 1 week prior to baseline);
Exclusion criteria
1. Participants with other medical conditions (excluding AD) that, as determined by the investigator, may interfere with the evaluation of efficacy or safety in this study, including but not limited to psoriasis, seborrheic dermatitis, systemic lupus erythematosus, moderate-to-severe acne, infectious folliculitis, etc.; 2. 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.; 3. Participants with a history of prior use of IRAK4 degraders, small-molecule IRAK4 inhibitors, or similar agents; 4. Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening; 5. Pregnant or lactating women, or participants with a positive pregnancy test result at screening;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Eczema Area and Severity Index (EASI) Score from Baseline at Week 16. | At Week 16. | The minimum EASI score is 0, and the maximum EASI score is 72. A score of 0 indicates clear or no eczema; a greater score indicates more severe disease. |
Contacts
Primary ContactXinghua Gao, PhD
Outcome results
None listed