ORKA-001-112 Enrolling

Research Trial for Moderate-to-Severe Plaque Psoriasis (106 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults (≥ 18 years of age) who have plaque psoriasis, may be eligible to participate.

 

Inclusion Criteria:

      • Body Mass Index (BMI) ≥ 18.5 and < 35 kg/m2
      • Stable diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months
      • Moderate-to-severe disease, with a Body Surface Area (BSA) ≥ 10% (i.e. 10 handprints)
      • Candidate for systemic therapy or phototherapy for psoriasis treatment

 

Participant Info:

      • No cost to participate or receive study medication
      • Regular visits with study doctors who are familiar with treating plaque psoriasis
      • Will receive investigational injected medication (active study drug) or placebo
      • Reimbursement for study-related expenses may be provided

 

How Long Will The Study Last?

Participation will last about 106 weeks and involve about 14 visits to the study research site (plus 2 phone visits).

After you have completed the study, you may have the opportunity to continue receiving ORKA-001 through another study.  The study team will discuss this with you in further detail.


Participating Locations

COUNTRY
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Canada

Participating Experts

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The following information is from ClinicalTrials.gov

Last Update Posted: August 18, 2025

Official Title

A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

ClinicalTrials.gov ID

NCT07090330

Sponsor

Oruka Therapeutics, Inc.

Study Description

  • Brief Summary:

    This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: ORKA-001 Induction Dose Other: Placebo Drug: ORKA-001 Maintenance Dose Drug: ORKA-001 Maintenance Dose Other: Placebo
  • Phase:

    PHASE 2

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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