Overall trial status: Ongoing, recruitment ended
Trial title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Dose-Range Finding Study of ORKA-001 in Participants with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate-to-Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16: 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) (Time Frame: Week 16)
Secondary end point: Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16: 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). (Time Frame: Week 16), Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 (Time Frame: Week 16), Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 (Time Frame: Week 16), Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 (Time Frame: Week 100), Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 (Time Frame: Week 100), Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and TEAEs of Special Interest (TEAESIs): 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. (Time Frame: Day 1 through Week 100)
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 32
Sponsor: Oruka Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: Placebo for ORKA-001, ORKA-001
Results posted: No
Overall decision date: 08/05/2026
Countries decision date: DE: 08/05/2026, ES: 11/05/2026
Last updated date: 19/08/2026
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