Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 469}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score', 'timeFrame': 'Week 24'}, {'measure': 'Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52', 'timeFrame': 'Baseline, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52', 'timeFrame': 'Baseline, Week 16, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52', 'timeFrame': 'Week 36 and Week 52'}, {'measure': 'Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52', 'timeFrame': 'Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52', 'timeFrame': 'Week 24, Week 36 and Week 52'}, {'measure': 'Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score', 'timeFrame': 'Baseline, Week 24, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52', 'timeFrame': 'Baseline, Week 36 and Week 52'}, {'measure': 'Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score', 'timeFrame': 'Baseline, Week 36 and Week 52'}, {'measure': 'Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately Week 68', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study subject irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious TEAE is any untoward medical occurrence that meets one of the following criteria: Is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or another medically important serious event.'}, {'measure': 'Number of Participants Experiencing AEs of Special Interest (EOIs)', 'timeFrame': 'Up to approximately Week 68'}, {'measure': 'Number of Participants with Anti-rocatinlimab Antibodies', 'timeFrame': 'Baseline to Week 68'}, {'measure': 'Serum Concentrations of Rocatinlimab', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Trough Concentration (Ctrough) of Rocatinlimab', 'timeFrame': 'Baseline to Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rocatinlimab'], 'conditions': ['Prurigo Nodularis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)\n* Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.\n* Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1.\n* Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.\n* History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).\n\nExclusion Criteria:\n\n* Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).\n* Prurigo nodularis secondary to medications.\n* Prurigo nodularis secondary to neurologic or psychiatric medical conditions.\n* Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.\n* Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.'}, 'identificationModule': {'nctId': 'NCT06527404', 'briefTitle': 'A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies', 'orgStudyIdInfo': {'id': '20230053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Blinded Treatment', 'description': 'Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.', 'interventionNames': ['Drug: Rocatinlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Blinded Treatment', 'description': 'Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.', 'interventionNames': ['Drug: Rocatinlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Blinded Treatment', 'description': 'Participants will receive matching placebo SC during Treatment Period A and B.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: Open-label', 'description': 'Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.', 'interventionNames': ['Drug: Rocatinlimab']}], 'interventions': [{'name': 'Rocatinlimab', 'type': 'DRUG', 'otherNames': ['AMG 451'], 'description': 'SC Injection', 'armGroupLabels': ['Arm A: Blinded Treatment', 'Arm B: Blinded Treatment', 'Arm D: Open-label']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC Injection', 'armGroupLabels': ['Arm C: Blinded Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at 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'33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Southern Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Dermatology and Laser Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Wellness Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Trials of Florida Inc', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian 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'44512', 'city': 'Boardman', 'state': 'Ohio', 'country': 'United States', 'facility': 'Optima Research', 'geoPoint': {'lat': 41.02423, 'lon': -80.66285}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State Physicians', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hightower Clinical', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center For Clinical Studies PLLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75146', 'city': 'Lancaster', 'state': 'Texas', 'country': 'United States', 'facility': 'Clarity Dermatology', 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has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}