Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-03 @ 6:31 AM
Study NCT ID:
NCT06216392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving EASI-75 at week 16', 'timeFrame': 'at Week 16', 'description': 'The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).'}, {'measure': 'Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16', 'timeFrame': 'at Week 16', 'description': 'IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).'}], 'secondaryOutcomes': [{'measure': 'Percent change of EASI score from baseline', 'timeFrame': 'Baseline up to Week 52', 'description': 'The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).'}, {'measure': 'Percent change of NRS score from baseline', 'timeFrame': 'Baseline up to Week 52', 'description': 'The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)'}, {'measure': 'Body surface area (BSA) of involvement of atopic dermatitis', 'timeFrame': 'Baseline up to Week 52', 'description': 'Change from baseline in percent of BSA'}, {'measure': 'Changes from baseline in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline up to Week 52', 'description': 'The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life.'}, {'measure': 'Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.', 'timeFrame': 'Baseline up to Week 60', 'description': 'Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.'}, {'measure': 'Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)', 'timeFrame': 'Baseline up to Week 60', 'description': 'anti-drug antibody (ADA) and neutralizing antibody (Nab)'}, {'measure': 'Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)', 'timeFrame': 'Baseline up to Week 52', 'description': 'SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible.'}, {'measure': 'Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)', 'timeFrame': 'Baseline up to Week 52', 'description': 'The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.\n2. Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.\n\nExclusion Criteria:\n\n1. Not enough washing-out period for previous therapy.\n2. Concurrent disease/status which may potentially affect the efficacy/safety judgement.\n3. Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.\n4. Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.\n5. Other"}, 'identificationModule': {'nctId': 'NCT06216392', 'briefTitle': 'Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genrix (Shanghai) Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'GR1802-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: GR1802', 'description': 'GR1802 injection 300mg every two weeks for 52-week treatment.', 'interventionNames': ['Biological: GR1802 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'GR1802 injection', 'type': 'BIOLOGICAL', 'description': '150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous', 'armGroupLabels': ['Experimental: GR1802']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': '0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jinhua Xu, PhD.', 'role': 'CONTACT', 'email': 'luhanyu@genrixbio.com', 'phone': '+86-021-52889999'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jinhua Xu, PhD.', 'role': 'CONTACT', 'email': 'xjhhsyy@163.com', 'phone': '021-52889999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genrix (Shanghai) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}