Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561806', 'term': 'lebrikizumab'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline', 'timeFrame': 'Baseline to Week 16', 'description': 'EASI-75 is a co-primary endpoint with IGA.'}, {'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score', 'timeFrame': 'Baseline to Week 16', 'description': 'IGA is a co-primary endpoint with EASI-75.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Percentage Change from Baseline in EASI Score', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Percentage Change from Baseline in Pruritus NRS Score', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Change from Baseline in Children Dermatology Life Quality Index (cDLQI)', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Change from Baseline in Body Surface Area (BSA)', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)', 'timeFrame': 'Baseline, Week 16'}, {'measure': 'Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration', 'timeFrame': 'Week 14'}, {'measure': 'Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)', 'timeFrame': 'Week 14'}, {'measure': 'Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Change from Baseline in SCORAD', 'timeFrame': 'Baseline, Week 16'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Eczema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/362456', 'label': 'A Study of Lebrikizumab (LY3650150) in Participants 6 Months to \\<18 Years of Age With Moderate-to-Severe Atopic Dermatitis'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \\<18 years of age with moderate-to-severe atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,\n\n * 12 months if participants are ≥6 years of age\n * 6 months if participants are 2 to \\<6 years of age\n * 3 months if participants are 6 months to \\<2 years of age.\n* Have an EASI score ≥16 at the screening and baseline\n* Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline\n* Have ≥10% BSA of AD involvement at the screening and baseline.\n\nExclusion Criteria:\n\n* Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Treatment with the following prior to the baseline:\n* An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.\n* Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \\<20%.\n* Treatment with a topical investigational drug within 2 weeks prior to the baseline.\n* Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.'}, 'identificationModule': {'nctId': 'NCT05559359', 'acronym': 'ADorable-1', 'briefTitle': 'A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '18265'}, 'secondaryIdInfos': [{'id': 'J2T-MC-KGBI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'DRM06-AD13', 'type': 'OTHER', 'domain': 'Dermira Inc'}, {'id': '2021-005232-29', 'type': 'EUDRACT_NUMBER'}, {'id': '2022-501476-25-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab (Cohort 1)', 'description': 'Participants who are 6 years to \\<18 years of age, 12 years to \\<18 years of age who weigh \\<40 kilogram (kg) or 6 years to \\<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).\n\nDosing will be based on weight.', 'interventionNames': ['Drug: Lebrikizumab', 'Drug: Topical Corticosteroid (TCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab (Cohort 2)', 'description': 'Participants who are 6 months to \\<6 years of age, 2 years to \\<6 years of age or 6 months to \\<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.\n\nDosing will be based on weight.', 'interventionNames': ['Drug: Lebrikizumab', 'Drug: Topical Corticosteroid (TCS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo matching lebrikizumab by SC injections with a TCS.', 'interventionNames': ['Drug: Placebo', 'Drug: Topical Corticosteroid (TCS)']}], 'interventions': [{'name': 'Lebrikizumab', 'type': 'DRUG', 'otherNames': ['LY3650150', 'DRM06'], 'description': 'Administered SC', 'armGroupLabels': ['Lebrikizumab (Cohort 1)', 'Lebrikizumab (Cohort 2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given SC', 'armGroupLabels': ['Placebo']}, {'name': 'Topical Corticosteroid (TCS)', 'type': 'DRUG', 'description': 'TCS administered', 'armGroupLabels': ['Lebrikizumab (Cohort 1)', 'Lebrikizumab (Cohort 2)', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-209-4101'}, {'name': 'Weily Soong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '602-933-2053'}, {'name': 'Harper Price', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72217', 'city': 'North Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '501-621-1100'}, {'name': 'Scott Dinehart', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arkansas Research Trials', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-531-2966'}, {'name': 'Vivian Laquer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First OC Dermatology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Antelope Valley Clinical Trials', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '310-337-7171'}, {'name': 'Howard Sofen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '916-524-1216'}, {'name': 'Jennifer Ornelas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 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'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '0403130173'}, {'name': 'Li-Chuen Wong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4102', 'city': 'Woolloongabba', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '001161730391300'}, {'name': 'Lynda Spelman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Veracity Clinical Research', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '14784400', 'city': 'Barretos', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Bruno Alvares', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundação Pio XII - Hospital de Câncer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '13060-803', 'city': 'Campinas', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Livia Leal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Pesquisa Sao Lucas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '55 51 33598571'}, {'name': 'Tania Cestari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14051-140', 'city': 'Ribeirão Preto', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Roberto Bueno Filho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '20241-180', 'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '+552125277979'}, {'name': 'ANA FILGUEIRAS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IBPClin - Instituto Brasil de Pesquisa Clínica', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '09060-870', 'city': 'Santo André', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '1149935459'}, {'name': 'Roberta Criado', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '18040-425', 'city': 'Sorocaba', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '551535194909'}, {'name': 'MARTTI ANTILA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica de Alergia Martti Antila', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}, {'zip': 'T2J 7E1', 'city': 'Calgary', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '4032633376'}, {'name': 'Vimal Prajapati', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Research Institute', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L4Y 4C5', 'city': 'Mississauga', 'status': 'RECRUITING', 'country': 'Canada', 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EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. 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