Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT06863961
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16', 'timeFrame': 'Baseline and Week 16'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32', 'timeFrame': 'At Week 16 and Week 32'}, {'measure': 'Percentage of Participants who Achieve EASI-75 Response at Week 32', 'timeFrame': 'At Week 32'}, {'measure': 'Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32', 'timeFrame': 'At Week 16 and Week 32'}, {'measure': 'Percent Change from Baseline in EASI by Visit', 'timeFrame': 'Baseline up to end of study (approximately 1 year)'}, {'measure': 'Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit', 'timeFrame': 'Baseline up to end of study (approximately 1 year)'}, {'measure': 'Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit', 'timeFrame': 'Baseline, weeks 4, 10, 16, 22 and 32'}, {'measure': 'Percentage of EASI-75 Responders at Week 16', 'timeFrame': 'At Week 16'}, {'measure': 'Percentage of Participants with Adverse Events', 'timeFrame': 'Baseline up to end of study (approximately 1 year)'}, {'measure': 'Serum Concentration of Afimkibart at Specified Timepoints', 'timeFrame': 'Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening\n* Moderate to severe AD\n* At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study\n\nExclusion Criteria:\n\n* Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis\n* IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study\n* Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study\n* Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline\n* Acquired or congenital immunodeficiency\n* Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study'}, 'identificationModule': {'nctId': 'NCT06863961', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'CS45570'}, 'secondaryIdInfos': [{'id': '2024-515494-95-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afimkibart Group I', 'description': 'Participants will receive afimkibart via subcutaneous (SC) injection.', 'interventionNames': ['Drug: Afimkibart']}, {'type': 'EXPERIMENTAL', 'label': 'Afimkibart Group II', 'description': 'Participants will receive afimkibart via SC injection.', 'interventionNames': ['Drug: Afimkibart']}, {'type': 'EXPERIMENTAL', 'label': 'Afimkibart Group III', 'description': 'Participants will receive afimkibart via SC injection.', 'interventionNames': ['Drug: Afimkibart']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo via SC injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Afimkibart', 'type': 'DRUG', 'otherNames': ['PF-06480605', 'RVT-3101', 'RO7790121'], 'description': 'Afimkibart will be administered as SC injection.', 'armGroupLabels': ['Afimkibart Group I', 'Afimkibart Group II', 'Afimkibart Group III']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as SC injection.', 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