Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:20 PM
Study NCT ID:
NCT07486960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-01-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology Response Criteria (ACR) 20% (ACR20)', 'timeFrame': 'Week 16', 'description': 'ACR20 is defined as a 20% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 20% or greater improvement in \\>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).'}], 'secondaryOutcomes': [{'measure': 'ACR 50% (ACR50)', 'timeFrame': 'Week 16', 'description': 'ACR50 is defined as a 50% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 50% or greater improvement in \\>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).'}, {'measure': 'ACR70', 'timeFrame': 'Week 16', 'description': 'ACR70 is defined as a 70% or greater improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints and b) 70% or greater improvement in \\>3 of the 5 components of i) Health Assessment Questionnaire Disability Index (HAQ-DI), ii) Physician Global Assessment of Disease Activity (PGA), iii) Patient Global Assessment (PtGA), iv) Patient Assessment of Pain Severity, and v) high sensitivity C-reactive protein (hsCRP).'}, {'measure': 'Change from Baseline in HAQ-DI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The HAQ-DI is a 20-item questionnaire that measures physical function. The questionnaire assesses the degree of difficulty a person has in accomplishing tasks in 8 functional area domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area domain are scored from 0 to 3 (0= without any difficulty; 3= unable to do), with a higher score indicating inability to perform activity. The overall disability score (HAQ-DI) is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3, with the higher value indicating worse disability.'}, {'measure': 'Number of Participants with ≥1 Adverse events', 'timeFrame': 'Up to ~Week 147', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the efficacy, safety, and tolerability of tulisokibart (MK-7240) in adult participants with active Psoriatic Arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a clinical diagnosis of PsA and fulfillment of the CASPAR criteria (Appendix 10) at Screening, with symptom onset ≥6 months before Screening.\n* Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.\n* Has history of bDMARD-naïve or bDMARD-IR/intolerant.\n\nExclusion Criteria:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.\n* Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.\n* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\<5 years before Randomization.\n* Has any active infection.\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.'}, 'identificationModule': {'nctId': 'NCT07486960', 'briefTitle': 'Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.', 'orgStudyIdInfo': {'id': '7240-015'}, 'secondaryIdInfos': [{'id': 'U1111-1318-4301', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2025-520997-21-00', 'type': 'REGISTRY', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose Regimen', 'description': 'Participants receive a high dose of tulisokibart.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Medium-Dose Regimen', 'description': 'Participants receive a medium dose of tulisokibart.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'EXPERIMENTAL', 'label': 'Low-Dose Regimen', 'description': 'Participants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart.', 'interventionNames': ['Drug: Tulisokibart']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Regimen', 'description': 'Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tulisokibart', 'type': 'DRUG', 'otherNames': ['MK-7240', 'PRA023'], 'description': 'Subcutaneous administration', 'armGroupLabels': ['High-Dose Regimen', 'Low-Dose Regimen', 'Medium-Dose Regimen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous administration', 'armGroupLabels': ['Placebo Regimen']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharpe & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}