Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07230860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of JNJ-95597528 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD 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 or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants with EASI 90 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD 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 or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.'}, {'measure': 'Proportion of Participants with EASI 100 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD 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 or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.'}, {'measure': 'Percent Change from Baseline in EASI Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change from baseline in EASI total score will be reported. EASI is a validated measure used to assess the severity and extent of AD 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 or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.'}, {'measure': 'Proportion of Participants with Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction of >= 2 Points from Baseline, at Week 12', 'timeFrame': 'Week 12', 'description': 'Proportion of participants with vIGA-AD score of 0 or 1 and a reduction of \\>=2 points from baseline at Week 12 will be reported. vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD.'}, {'measure': 'Proportion of Participants with vIGA-AD Score of 0 and a Reduction of >= 2 points from Baseline, at Week 12', 'timeFrame': 'Week 12', 'description': 'Proportion of participants with vIGA-AD score of 0 and a reduction of \\>=2 points from baseline at Week 12 will be reported. vIGA-AD is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the morphological descriptors that best describe the overall appearance of the AD lesions at a given time point. Higher scores are indicative of a more severe AD.'}, {'measure': 'Proportion of Participants with >= 4-Point Improvement in Peak Pruritus Numeric(al) Rating Scale (PP-NRS) from Baseline, at Week 12', 'timeFrame': 'Week 12', 'description': 'Proportion of participants with \\>=4-point improvement from baseline in PP-NRS scale at Week 12 will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity.'}, {'measure': 'Percent Change from Baseline in PP-NRS Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change from baseline in PP-NRS score will be reported. PP-NRS is a single item asking participants to assess their worst itch over the past 24 hours. There are 11 response categories, ranging from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates greater severity.'}, {'measure': 'Percent Change from Baseline in Score of Item 2 of Atopic Dermatitis Sleep Scale (AD Sleep Scale) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change from baseline in the score of Item 2 of AD Sleep Scale at Week 12 will be reported. The AD Sleep Scale is a validated 3-item participant-reported outcome (PRO) instrument to capture self-reported impact of itch on sleep disturbance each day, including difficulty falling asleep, number of night-time awakenings, and difficulty falling back asleep after waking during the previous night. For Item 2, participants select the number of times they woke up each night, ranging from 0 to 29 times. Higher score indicates more sleep disturbance.'}, {'measure': 'Proportion of Participants with >= 4 Point Improvement in Skin Pain Numeric Rating Scale (Skin Pain NRS) from Baseline, at Week 12', 'timeFrame': 'Week 12', 'description': 'Proportion of participants with \\>= 4 point improvement from baseline in skin pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain.'}, {'measure': 'Percent Change from Baseline in Skin Pain NRS at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Percent change from baseline in Skin Pain NRS at Week 12 will be reported. Skin Pain NRS is a single item asking participants to assess their worst skin pain over the past 24 hours. There are 11 response categories, ranging from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates more pain.'}, {'measure': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to approximately Week 12', 'description': 'An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that has worsened since baseline. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how well JNJ-95597528 works compared to placebo 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* Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening\n* Meets all the following disease activity criteria: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (\\>=) 16 at the screening and Week 0; c. validated investigator global assessment for atopic dermatitis (vIGA-AD) score \\>= 3 at screening and Week 0; d. \\>= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening)\n* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies)\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures\n\nExclusion criteria:\n\n* History of substance abuse or alcohol abuse within 1 year before screening\n* In the investigator's opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study\n* Known or suspected immunodeficiency, including history of invasive opportunistic infections\n* Previously received JNJ-95597528\n* Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, monoclonal antibodies (mAbs), or antibody fragments"}, 'identificationModule': {'nctId': 'NCT07230860', 'acronym': 'READY-AD', 'briefTitle': 'A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '95597528ADM2001'}, 'secondaryIdInfos': [{'id': '95597528ADM2001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2025-523464-20-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: JNJ-95597528 (Dose 1)', 'description': 'Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.', 'interventionNames': ['Drug: JNJ-95597528']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: JNJ-95597528 (Dose 2 and 3)', 'description': 'Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.', 'interventionNames': ['Drug: JNJ-95597528']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: JNJ-95597528 (Dose 4 and 5)', 'description': 'Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.', 'interventionNames': ['Drug: JNJ-95597528']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)', 'description': 'Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.', 'interventionNames': ['Drug: JNJ-95597528', 'Drug: Placebo']}], 'interventions': [{'name': 'JNJ-95597528', 'type': 'DRUG', 'description': 'JNJ-95597528 will be administered subcutaneously.', 'armGroupLabels': ['Group 1: JNJ-95597528 (Dose 1)', 'Group 2: JNJ-95597528 (Dose 2 and 3)', 'Group 3: JNJ-95597528 (Dose 4 and 5)', 'Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered subcutaneously.', 'armGroupLabels': ['Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Study Contact', 'role': 'CONTACT', 'email': 'Participate-In-This-Study1@its.jnj.com', 'phone': '844-434-4210'}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of Johnson \\& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}