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

NCT07344051 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS12010-201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Eczema Area and Severity Index (EASI) Score from Baseline 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.

  At Week 16.

Study Arms (4)

QLS12010 Capsule Dose 1 Group

EXPERIMENTAL

Drug: QLS12010

QLS12010 Capsule Dose 2 Group

EXPERIMENTAL

Drug: QLS12010

QLS12010 Capsule Dose 3 Group

EXPERIMENTAL

Drug: QLS12010

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QLS12010 DRUG

QLS12010 oral capsule

QLS12010 Capsule Dose 1 Group; QLS12010 Capsule Dose 2 Group; QLS12010 Capsule Dose 3 Group

Placebo DRUG

Matching placebo oral capsule

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Xinghua Gao, PhD

CONTACT

13940152467; gaobarry@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01