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Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis | Clinical Trials | Clareo Health

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

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

NCT07474792•Oruka Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo. The study will consist of 3 periods: * Screening Period * Induction Period * Post-treatment Follow-up Period

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants ≥ 18 and \< 80 years of age at the time of consent
•2. Have a diagnosis of plaque psoriasis for \> 6 months
•3. Have moderate-to-severe chronic plaque psoriasis defined as:
•1. BSA ≥ 10%, and
•2. PASI ≥ 12, and
•3. IGA score of ≥ 3 on a 5-point scale
•4. Candidate for systemic therapy or phototherapy
•5. Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria

•1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)
•2. 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
•3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
•4. A known hypersensitivity to any components of the ORKA-002 drug product
•5. Women who are breastfeeding or plan to breastfeed during the study

Key Dates

Start Date

March 1, 2026

Primary Completion Date

October 1, 2027

Completion Date

April 1, 2029

Last Updated

March 16, 2026

Enrollment

160

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

ORKA-002

DRUG

Placebo

OTHER

Contacts

Oruka Clinical Trials Information

CONTACT

781-560-0299 clinicaltrials@orukatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

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