RECRUITING

ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07090330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants ≥ 18 years of age
  2. 2. Have a diagnosis of plaque psoriasis for \> 6 months
  3. 3. Have moderate-to-severe chronic plaque psoriasis defined as:
  4. 1. BSA ≥ 10%, and
  5. 2. PASI ≥ 12, and
  6. 3. IGA score of ≥ 3 on a 5-point scale
  7. 4. Candidate for systemic therapy or phototherapy
  8. 5. Women of childbearing potential must have a negative pregnancy test
  1. 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
  2. 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. 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
  4. 4. A known hypersensitivity to any components of the ORKA-001 drug product
  5. 5. Women who are breastfeeding or plan to breastfeed during the study

Contacts and Locations

Study Contact

Oruka Clinical Trials Information
CONTACT
781-560-0299
clinicaltrials@orukatx.com

Study Locations (Sites)

Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
United States
Oruka Therapeutics Investigative Site
San Diego, California, 92123
United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, 33134
United States
Oruka Therapeutics Investigative Site
New York, New York, 10023
United States

Collaborators and Investigators

Sponsor: Oruka Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-08
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Phase 2
  • ORKA-001
  • Plaque psoriasis

Additional Relevant MeSH Terms

  • Plaque Psoriasis