ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis (EVERLAST-A)

Oruka Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: ORKA-001 Maintenance Dose; Drug: ORKA-001 Induction Dose; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090330

ORKA-001-112

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 5 patient groups, including a placebo group

(Induction Period) ORKA-001

Experimental group

Description:

Participants will receive ORKA-001 per protocol Induction regimen.

Treatment:

Drug: ORKA-001 Induction Dose

(Induction Period) Placebo

Placebo Comparator group

Description:

Participants will receive Placebo per protocol Induction regimen.

Treatment:

Other: Placebo

(Maintenance Period - Arm 1) ORKA-001

Experimental group

Description:

Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Treatment:

Drug: ORKA-001 Maintenance Dose

(Maintenance Period - Arm 2) ORKA-001

Experimental group

Description:

Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Treatment:

Drug: ORKA-001 Maintenance Dose

(Maintenance Period - Arm 3) Placebo

Placebo Comparator group

Description:

Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.

Treatment:

Other: Placebo