What is ORKA-001 studying for moderate-to-severe plaque psoriasis?

ORKA-001 is being studied to evaluate its effects and safety in adults with moderate-to-severe plaque psoriasis. Researchers want to find the best dosing plan to reduce psoriasis symptoms. This study is sponsored by Oruka Therapeutics, Inc. and aims to help understand how this treatment works for patients.

Who may be eligible for this plaque psoriasis clinical trial?

Adults aged 18 years or older with a diagnosis of moderate-to-severe plaque psoriasis for more than 6 months may be eligible. There is no gender restriction. Participants must have significant skin involvement and be candidates for systemic or phototherapy treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this plaque psoriasis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07290569

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

Led by Oruka Therapeutics, Inc. · Updated on 2026-06-02

160

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects and safety of ORKA-001, a drug given by injection, in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled Phase 2 study aims to find the best initial dosing plan of ORKA-001 by comparing three different doses against a placebo. The study includes about 160 adult participants who have had plaque psoriasis for more than six months and meet specific disease severity criteria. The study consists of four periods: a screening period lasting up to six weeks, an induction treatment period lasting up to 28 weeks, a maintenance period of approximately 72 weeks, and a post-treatment follow-up. During the induction period, participants receive one of three doses of ORKA-001 or placebo by subcutaneous injection. In the maintenance period, participants receive either 300 mg or 600 mg ORKA-001 or placebo based on their response to the initial treatment. After treatment ends, participants may enter an open-label extension or be followed for 48 weeks after early termination. Throughout the study, participants will be monitored for treatment effects and safety. Researchers will measure the proportion of participants achieving complete clearance of psoriasis symptoms at 16 weeks and the maintenance of skin clearance at 100 weeks. Other assessments include skin severity scores and recording adverse events. Participants will have regular visits for evaluations, and women of childbearing potential will have pregnancy testing to ensure safety during the trial.

CONDITIONS

Brief Title

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants 18 years of age or older
Diagnosis of plaque psoriasis for more than 6 months
Moderate-to-severe chronic plaque psoriasis with Body Surface Area (BSA) 10% or greater
PASI score of 12 or higher
Investigator's Global Assessment (IGA) score of 3 or higher on a 5-point scale
Candidate for systemic therapy or phototherapy
Women of childbearing potential must have a negative pregnancy test

You will not qualify if you...

Nonplaque forms of psoriasis such as guttate, erythrodermic, pustular, or drug-induced psoriasis
Significant history or symptoms of metabolic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, psychiatric disorders, or infectious diseases
History of cancer except non-melanoma skin cancer or cancer treated curatively 5 or more years ago without recurrence
Known allergy to any components of ORKA-001
Women who are breastfeeding or planning to breastfeed during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - Up to 6 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Induction Period

Duration - Up to 28 weeks

Participants receive one of three dosing regimens of ORKA-001 or placebo by subcutaneous injection to evaluate efficacy and safety.

Multiple visits during the induction period as per protocol

Maintenance Period

Duration - Up to approximately 72 weeks

Participants continue treatment with maintenance dosing regimens of ORKA-001 or placebo based on response during induction.

Regular visits during maintenance period as per protocol

Post-treatment Follow-up Period

Duration - 48 weeks after End of Treatment or Early Termination

Participants who do not enter the open-label extension study or who withdraw are followed for safety and outcomes after treatment ends.

Periodic follow-up visits for safety monitoring