Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:25 AM
Study NCT ID:
NCT07449702
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)', 'timeFrame': 'Day 1 through Week 144', 'description': 'Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Maintaining or with Improvement of OLE Baseline PASI Score', 'timeFrame': 'Day 1 through Week 96', 'description': 'Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).'}, {'measure': 'Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE', 'timeFrame': 'Day 1 through Week 96', 'description': 'The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).'}, {'measure': 'Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE', 'timeFrame': 'Day 1 through Week 96', 'description': 'The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).'}, {'measure': "Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE", 'timeFrame': 'Day 1 through Week 96', 'description': "The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4)."}, {'measure': "Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE", 'timeFrame': 'Time Frame: Day 1 through Week 96', 'description': "The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4)."}, {'measure': 'Time-to-loss of PASI100 in Subset of Participants with PASI100 at Baseline of OLE', 'timeFrame': 'Day 1 through Week 96', 'description': 'The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).'}, {'measure': 'PASI Score Over Time', 'timeFrame': 'Day 1 through Week 96', 'description': 'The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).'}, {'measure': 'IGA Score Over Time', 'timeFrame': 'Day 1 through Week 96', 'description': "The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 2', 'ORKA-001', 'Open Label Extension', 'OLE'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.', 'detailedDescription': 'This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent by participants from previous trial choosing to transition into the OLE.\n2. Participants who have successfully completed the preceding trial.\n3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.\n4. For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception\n\nExclusion Criteria:\n\n1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that, in the opinion of the Investigator, would preclude continued treatment with ORKA-001\n2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.\n3. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.\n4. Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.\n5. Participant is pregnant or breastfeeding."}, 'identificationModule': {'nctId': 'NCT07449702', 'briefTitle': 'An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oruka Therapeutics, Inc.'}, 'officialTitle': 'An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'ORKA-001-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORKA-001 Once Yearly', 'description': 'Participants will receive ORKA-001 once a year per OLE protocol.', 'interventionNames': ['Drug: ORKA-001']}, {'type': 'EXPERIMENTAL', 'label': 'ORKA-001 Twice Yearly', 'description': 'Participants will receive ORKA-001 every 6 months per OLE protocol.', 'interventionNames': ['Drug: ORKA-001']}, {'type': 'NO_INTERVENTION', 'label': 'No Drug', 'description': 'Participants will receive no drug until protocol defined PASI response criterion is met.'}], 'interventions': [{'name': 'ORKA-001', 'type': 'DRUG', 'description': 'ORKA-001 administered by subcutaneous (SC) injection', 'armGroupLabels': ['ORKA-001 Once Yearly', 'ORKA-001 Twice Yearly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '42104', 'city': 'Bowling Green', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Oruka Investigative Site', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}], 'facility': 'Oruka Therapeutics Investigative Site', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}], 'centralContacts': [{'name': 'Oruka Clinical Trials Information', 'role': 'CONTACT', 'email': 'clinicaltrials@orukatx.com', 'phone': '781-560-0299'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oruka Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}