Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

Oruka Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Other: Placebo; Drug: ORKA-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT07474792

ORKA-002-212

Details and patient eligibility

About

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.

Full description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.

The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.

The study will consist of 3 periods:

• Screening Period
• Induction Period
• Post-treatment Follow-up Period

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants ≥ 18 and < 80 years of age at the time of consent

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-002 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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160 participants in 4 patient groups, including a placebo group

(Induction Period - Arm 1) ORKA-002

Experimental group

Description:

Participants will receive ORKA-002 per protocol Induction regimen.

Treatment:

Drug: ORKA-002

(Induction Period - Arm 2) ORKA-002

Experimental group

Description:

Participants will receive ORKA-002 per protocol Induction regimen.

Treatment:

Drug: ORKA-002

(Induction Period - Arm 3) ORKA-002

Experimental group

Description:

Participants will receive ORKA-002 per protocol Induction regimen.

Treatment:

Drug: ORKA-002

(Induction Period - Arm 4) Placebo

Placebo Comparator group

Description:

Participants will receive Placebo per protocol Induction regimen.

Treatment:

Other: Placebo