A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis

Qilu Pharmaceutical

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Drug: QLS12010; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07344051

QLS12010-201

Details and patient eligibility

About

This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

QLS12010 Capsule Dose 1 Group

Experimental group

Treatment:

Drug: QLS12010

QLS12010 Capsule Dose 2 Group

Experimental group

Treatment:

Drug: QLS12010

QLS12010 Capsule Dose 3 Group

Experimental group

Treatment:

Drug: QLS12010

Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo