A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis
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: Moderate-to-severe Atopic Dermatitis. 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 Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Overview
This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.
Interventions
- Drug QLS12010
QLS12010 oral capsule - Drug Placebo
Matching placebo oral capsule
Primary outcome measures
- Percentage Change in Eczema Area and Severity Index (EASI) Score from Baseline at Week 16. [Time frame: At Week 16.]
Eligibility criteria
Inclusion criteria
- At screening, the diagnosis of atopic dermatitis (AD) shall meet the Hanifin-Rajka criteria, with a duration of AD ≥ 1 year prior to baseline;
- 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%;
- 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
- 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.;
- 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 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: NCT07344051 · QLS12010-201