What is ORKA-002 studying for plaque psoriasis?

ORKA-002 is being studied to find the best dose for treating moderate-to-severe plaque psoriasis and to assess its safety. This study compares different dosing schedules of ORKA-002 against a placebo to understand its effects. The research is sponsored by Oruka Therapeutics, Inc.

Who may be eligible for this plaque psoriasis clinical trial?

Adults aged 18 to 79 years with moderate-to-severe plaque psoriasis diagnosed for more than 6 months may be eligible. Participants must be candidates for systemic therapy or phototherapy and not be breastfeeding. 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. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 79Years

All Genders

ID07474792

Dose-Range Finding Study to Evaluate ORKA-002 Efficacy and Safety in Adults With Moderate-to-Severe Plaque Psoriasis

Led by Oruka Therapeutics, Inc. · Updated on 2026-05-27

160

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of ORKA-002 in adults with moderate-to-severe plaque psoriasis. This multicenter trial is a randomized, double-blinded, placebo-controlled phase 2 study aiming to find the best induction dose of ORKA-002 to treat this skin condition. The study involves about 160 participants to evaluate both the effectiveness and safety of the medication compared to a placebo. Participants will be randomly assigned to receive one of three different dosing regimens of ORKA-002 or a placebo, with all treatments given by subcutaneous injection. The study includes a screening period to determine eligibility, an induction period where participants receive the assigned treatment, and a post-treatment follow-up period to monitor outcomes and safety. During the trial, participants will undergo assessments including skin evaluations using PASI and IGA scores to measure psoriasis severity and improvement. Safety will be closely monitored through reports of treatment-emergent adverse events up to 48 weeks. The total involvement includes screening, treatment, and follow-up to assess both short- and longer-term effects of ORKA-002.

CONDITIONS

Brief Title

Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

Who Can Participate

Age: 18Years - 79Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to less than 80 years at consent
Diagnosed with plaque psoriasis for more than 6 months
Moderate-to-severe chronic plaque psoriasis with body surface area (BSA) of at least 10%, PASI score of at least 12, and 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, including guttate, erythrodermic, pustular, or drug-induced psoriasis
Significant history or clinical signs of metabolic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, psychiatric disorders, or infectious diseases
History of malignancy except for non-melanoma skin cancer or cancer treated curatively at least 5 years ago without recurrence
Known allergy to any components of ORKA-002
Women who are breastfeeding or plan 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 - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 16 weeks

Participants receive ORKA-002 or placebo by subcutaneous injection according to one of three induction dosing regimens to evaluate efficacy and safety.

Visits as per dosing schedule during induction period

Post-treatment Follow-up

Duration - Up to 32 weeks after treatment

Participants are monitored for safety and treatment effects after the induction period ends.

Follow-up visits throughout this period