RECRUITING

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

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.

Conditions

Plaque Psoriasis
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Related Conditions:

Plaque Psoriasis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Oruka Therapeutics Investigative Site, Los Angeles, California, United States, 90045

San Diego

Oruka Therapeutics Investigative Site, San Diego, California, United States, 92123

Coral Gables

Oruka Therapeutics Investigative Site, Coral Gables, Florida, United States, 33134

New York

Oruka Therapeutics Investigative Site, New York, New York, United States, 10023

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants ≥ 18 years of age
  • 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
  • 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-001 drug product
  • 5. Women who are breastfeeding or plan to breastfeed during the study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oruka Therapeutics, Inc.,

Study Record Dates

2027-05