Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT06468956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 652}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-06-16', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)', 'timeFrame': 'up to 16 weeks', 'description': 'The extent of area is assessed using the EASI scale'}, {'measure': 'At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 and a decrease of ≥2 points from baseline', 'timeFrame': 'up to 16 week', 'description': 'The overall degree of improvement was assessed using the IGA scale'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16', 'timeFrame': 'up to 16 weeks', 'description': 'Prtch improvement was assessed using the pruritus scale'}, {'measure': 'At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline)', 'timeFrame': 'up to 16 weeks', 'description': 'The extent of area is assessed using the EASI scale'}, {'measure': 'Proportion of subjects reaching EASI-75 at other visit viewpoints', 'timeFrame': 'up to 52 weeks', 'description': 'The extent of area is assessed using the EASI scale'}, {'measure': 'The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline', 'timeFrame': 'up to 52 weeks', 'description': 'The overall degree of improvement was assessed using the IGA scale'}, {'measure': 'Proproportion of subjects with a 2 points from baseline at each iGA', 'timeFrame': 'up to 52 weeks', 'description': 'The overall degree of improvement was assessed using the IGA scale'}, {'measure': 'Percentage of change and change from baseline in EASI per visit viewpoint', 'timeFrame': 'up to 52 weeks', 'description': 'The extent of area is assessed using the EASI scale'}, {'measure': 'Percentage of subjects with weekly mean PP-NRS scores of 3 points from baseline', 'timeFrame': 'up to 52 weeks', 'description': 'Prtch improvement was assessed using the pruritus scale'}, {'measure': 'Percentage of change and change from baseline in the Skin Quality of Life Index Questionnaire (DLQI) score at each visit viewpoint', 'timeFrame': 'From the beginning of administration to the 52 week', 'description': 'Subject quality of life was assessed using the DLQI scale'}, {'measure': 'Percentage of change from baseline in eczema self-assessment (POEM) scores at each viewpoint', 'timeFrame': 'From the beginning of administration to the 52 week', 'description': 'Subject quality of life was assessed using the POEM scale'}, {'measure': 'The time of SHR-1819 in the serum', 'timeFrame': 'From the beginning of administration to the 52th week', 'description': 'The concentration of SHR-1819 in plasma will be determined'}, {'measure': 'The concentration of SHR-1819 in serum: AUC', 'timeFrame': 'From the beginning of administration to the 52th week', 'description': 'The concentration of SHR-1819 in plasma will be determined'}, {'measure': 'Changes in the level of IgE in the serum', 'timeFrame': 'From the beginning of administration to the 52th week', 'description': 'Changes in the level of biomarkers in serum'}]}, '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 SHR-1819 injection in patients with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol；\n2. The age was ≥18 at the time of signing the informed consent and gender is unlimited;\n3. Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;\n4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;\n5. TCS was not optimal or not tolerated by the investigator.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Major surgeries are planned for the duration of the study;\n3. History of previous atopic corneal conjunctivitis involving the cornea;\n4. History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;\n5. Subjects have had or are currently clinically significant diseases or abnormalities;\n6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;\n7. The drug has been used in the previous 6 months;\n8. Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);\n9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;\n10. Any cause that the researchers believe would prevent the participants from participating in the study.'}, 'identificationModule': {'nctId': 'NCT06468956', 'briefTitle': 'Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'SHR-1819-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1819 injection dose 1', 'interventionNames': ['Drug: SHR-1819']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1819 injection dose 2', 'interventionNames': ['Drug: SHR-1819']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR-1819', 'type': 'DRUG', 'description': 'SHR-1819 injection', 'armGroupLabels': ['SHR-1819 injection dose 1', 'SHR-1819 injection dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Fudan University HuaShan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}