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

NCT ID: NCT07344051

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-05
• Study Completion Date: 2027-09-30

Brief Summary

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

Conditions

Moderate-to-severe Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QLS12010 Capsule Dose 1 Group

Group Type: EXPERIMENTAL

QLS12010

Intervention Type: DRUG

QLS12010 oral capsule

QLS12010 Capsule Dose 2 Group

Group Type: EXPERIMENTAL

QLS12010

Intervention Type: DRUG

QLS12010 oral capsule

QLS12010 Capsule Dose 3 Group

Group Type: EXPERIMENTAL

QLS12010

Intervention Type: DRUG

QLS12010 oral capsule

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo oral capsule

Interventions

QLS12010

QLS12010 oral capsule

Intervention Type: DRUG

Placebo

Matching placebo oral capsule

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xinghua Gao, PhD

Role: CONTACT

gaobarry@hotmail.com

13940152467

Other Identifiers

QLS12010-201

Identifier Type: -

Identifier Source: org_study_id