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

Phase 2Active Not RecruitingNCT07090330

Oruka Therapeutics, Inc.80 enrolled

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.

This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

ORKA-001 Induction DoseDRUG

ORKA-001 Induction Dose, administered by subcutaneous (SC) injection

PlaceboOTHER

Placebo administered by subcutaneous (SC) injection

ORKA-001 Maintenance DoseDRUG

ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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 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-001 drug product 5. Women who are breastfeeding or plan to breastfeed during the study

Locations (26)

Outcomes

Primary Outcomes

Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16

The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).

Time frame: Week 16

Secondary Outcomes

Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16

The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).

Time frame: Week 16

Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16

Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).

Time frame: Week 16

Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16

Time frame: Week 16

Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 52

Data from ClinicalTrials.gov

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