Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis (EVERLAST-B)

Oruka Therapeutics, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Other: Placebo; Drug: ORKA-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07290569

ORKA-001-114

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-001 in adult participants with moderate-to-severe plaque psoriasis.

Full description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 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-001 compared to placebo and will include 3 maintenance regimens.

The study will consist of 4 periods:

• Screening Period of up to 6 weeks
• Induction Period of up to 28 weeks (Day 1 [Baseline] to Week 28)
• Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100)
• Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.

Enrollment: 160 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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160 participants in 7 patient groups, including a placebo group

(Induction Period - Arm 1) ORKA-001

Experimental group

Description:

Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.

Treatment:

Drug: ORKA-001

(Induction Period - Arm 2) ORKA-001

Experimental group

Description:

Participants will receive 300 mg ORKA-001 per protocol Induction regimen.

Treatment:

Drug: ORKA-001

(Induction Period - Arm 3) ORKA-001

Experimental group

Description:

Participants will receive 600 mg ORKA-001 per protocol Induction regimen.

Treatment:

Drug: ORKA-001

(Induction Period - Arm 4) 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 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Treatment:

Drug: ORKA-001

(Maintenance Period - Arm 2) ORKA-001

Experimental group

Description:

Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.

Treatment:

Drug: ORKA-001

(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