ORKA-001 for Moderate-to-severe plaque psoriasis

Inclusion criteria

• {"criterion_text":"- Participants ≥ 18 years of age\n- Have a diagnosis of plaque psoriasis for > 6 months\n- Have moderate-to-severe chronic plaque psoriasis defined as: a. BSA ≥ 10%, and b. PASI ≥ 12, and c. IGA score of ≥ 3 on a 5-point scale\n- Candidate for systemic therapy or phototherapy\n- Women of childbearing potential must have a negative pregnancy test"}

Exclusion criteria

• {"criterion_text":"- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis\n- 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\n- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence\n- A known hypersensitivity to any components of the ORKA-001 drug product\n- Women who are breastfeeding or plan to breastfeed during the study"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"PASI score combining severity and affected area into a single score 0–72; endpoint measured as proportion achieving 100% reduction in PASI at Week 16 (Time Frame: Week 16)."}

Secondary endpoints

• {"endpoint_text":"- 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)\n- Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 (Time Frame: Week 16)\n- Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 (Time Frame: Week 16)\n- Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 (Time Frame: Week 100)\n- Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 (Time Frame: Week 100)\n- Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 (Time Frame: Week 100)\n- Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 (Time Frame: Week 100)\n- Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 (Time Frame: Week 100)\n- Incidence of Treatment-emergent Adverse Events (TEAEs) 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)","definition_or_measurement_approach":"IGA: investigator assessment graded 0–4 (clear to severe); PASI: percent reduction from baseline at specified weeks (Week 16, Week 100). Safety endpoints: incidence counts of TEAEs/TEAESIs and clinically significant changes from baseline in vitals, labs and ECGs (Time Frame: Day 1 through Week 100)."}

Methods

• Patient recruitment managed by Galen Patient Recruitment Inc. (role: Patient Recruitment) targeting patients with moderate-to-severe plaque psoriasis via site and patient outreach.
• Site-based recruitment through participating hospitals/clinics in Germany and Spain (listed trial sites include university hospitals and dermatology departments).
• Participant reimbursement and stipends provided (as indicated in Suvoda LLC sponsor duties: "reimbursement and participant stipends; EDC is ePRO and eCOA").
• Use of electronic data capture and patient-reported outcome collection (ePRO and eCOA) as part of participant data collection (noted in Suvoda LLC duties).

Germany

Earliest CTIS Part Ii Submission Date

15-04-2026

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

23

Number Of Sites

4

Number Of Participants

16

Spain

Earliest CTIS Part Ii Submission Date

28-01-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

103

Number Of Sites

4

Number Of Participants

16

Primary sponsor

Full Name

Oruka Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Premier Research International LLC

Responsibilities

eTMF, Investigator payments; multiple operational and regulatory responsibilities

Name

Propharma Group LLC

Responsibilities

Independent Data Monitoring Committee, Adjudication Comittee

Name

WCG Clinical Inc.

Responsibilities

Rater Training; central IRB for North American sites

Name

Clario

Responsibilities

ECG

Name

Labcorp Central Laboratory Services Sàrl

Responsibilities

Central laboratory services

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"reimbursement and participant stipends; EDC is ePRO and eCOA","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"Independent Data Monitoring Committee, Adjudication Comittee","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"","organisation_type":"Health care"}
• {"country":"United States","full_name":"Galen Patient Recruitment Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Rater Training; central IRB for North American sites","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"eTMF, Investigator payments; additional operational roles (multiple codes listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"ECG","organisation_type":"Industry"}
• {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}