Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:50 AM
Study NCT ID:
NCT07474792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16', 'timeFrame': 'Week 16', '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': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)', 'timeFrame': 'Day 1 through Week 48', 'description': 'Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16', 'timeFrame': 'Week 16', '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 Achieving 90% Reduction in PASI Score at Week 16', 'timeFrame': 'Week 16', '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 Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at Week 16', 'timeFrame': 'Week 16', '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': 'Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs)', 'timeFrame': 'Day 1 through Week 48', 'description': 'Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 2', 'Plaque psoriasis', 'ORKA-002'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.', 'detailedDescription': 'This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.\n\nThe study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.\n\nThe study will consist of 3 periods:\n\n* Screening Period\n* Induction Period\n* Post-treatment Follow-up Period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants ≥ 18 and \\< 80 years of age at the time of consent\n2. Have a diagnosis of plaque psoriasis for \\> 6 months\n3. Have moderate-to-severe chronic plaque psoriasis defined as:\n\n 1. BSA ≥ 10%, and\n 2. PASI ≥ 12, and\n 3. IGA score of ≥ 3 on a 5-point scale\n4. Candidate for systemic therapy or phototherapy\n5. Women of childbearing potential must have a negative pregnancy test\n\nExclusion Criteria:\n\n1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)\n2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease\n3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence\n4. A known hypersensitivity to any components of the ORKA-002 drug product\n5. Women who are breastfeeding or plan to breastfeed during the study'}, 'identificationModule': {'nctId': 'NCT07474792', 'briefTitle': 'Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oruka Therapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'ORKA-002-212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Induction Period - Arm 1) ORKA-002', 'description': 'Participants will receive ORKA-002 per protocol Induction regimen.', 'interventionNames': ['Drug: ORKA-002']}, {'type': 'EXPERIMENTAL', 'label': '(Induction Period - Arm 2) ORKA-002', 'description': 'Participants will receive ORKA-002 per protocol Induction regimen.', 'interventionNames': ['Drug: ORKA-002']}, {'type': 'EXPERIMENTAL', 'label': '(Induction Period - Arm 3) ORKA-002', 'description': 'Participants will receive ORKA-002 per protocol Induction regimen.', 'interventionNames': ['Drug: ORKA-002']}, {'type': 'PLACEBO_COMPARATOR', 'label': '(Induction Period - Arm 4) Placebo', 'description': 'Participants will receive Placebo per protocol Induction regimen.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ORKA-002', 'type': 'DRUG', 'description': 'ORKA-002 administered by subcutaneous (SC) injection', 'armGroupLabels': ['(Induction Period - Arm 1) ORKA-002', '(Induction Period - Arm 2) ORKA-002', '(Induction Period - Arm 3) ORKA-002']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo administered by subcutaneous (SC) injection', 'armGroupLabels': ['(Induction Period - Arm 4) Placebo']}]}, 'contactsLocationsModule': {'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'}}}}