Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:34 AM
Study NCT ID:
NCT07344051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Eczema Area and Severity Index (EASI) Score from Baseline at Week 16.', 'timeFrame': 'At Week 16.', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate-to-severe Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This trial was designed to evaluate the efficacy and safety of QLS12010 Capsules in adults with moderate-to-severe atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At screening, the diagnosis of atopic dermatitis (AD) shall meet the Hanifin-Rajka criteria, with a duration of AD ≥ 1 year prior to baseline;\n2. 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%;\n3. 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);\n\nExclusion Criteria:\n\n1. 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.;\n2. 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.;\n3. Participants with a history of prior use of IRAK4 degraders, small-molecule IRAK4 inhibitors, or similar agents;\n4. Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening;\n5. Pregnant or lactating women, or participants with a positive pregnancy test result at screening;"}, 'identificationModule': {'nctId': 'NCT07344051', 'briefTitle': 'A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'QLS12010-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS12010 Capsule Dose 1 Group', 'interventionNames': ['Drug: QLS12010']}, {'type': 'EXPERIMENTAL', 'label': 'QLS12010 Capsule Dose 2 Group', 'interventionNames': ['Drug: QLS12010']}, {'type': 'EXPERIMENTAL', 'label': 'QLS12010 Capsule Dose 3 Group', 'interventionNames': ['Drug: QLS12010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QLS12010', 'type': 'DRUG', 'description': 'QLS12010 oral capsule', 'armGroupLabels': ['QLS12010 Capsule Dose 1 Group', 'QLS12010 Capsule Dose 2 Group', 'QLS12010 Capsule Dose 3 Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo oral capsule', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xinghua Gao, PhD', 'role': 'CONTACT', 'email': 'gaobarry@hotmail.com', 'phone': '13940152467'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}