Recruiting

Phase 2

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

Sponsor:

Oruka Therapeutics, Inc.

Code:

NCT07474792

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ORKA-002

Placebo

Study Details

Brief summary:

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.

Conditions

Plaque Psoriasis

Study ID

NCT07474792

Start date

Mar 19, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: (Induction Period - Arm 1) ORKA-002

Participants will receive ORKA-002 per protocol Induction regimen.

experimental: (Induction Period - Arm 2) ORKA-002

Participants will receive ORKA-002 per protocol Induction regimen.

experimental: (Induction Period - Arm 3) ORKA-002

Participants will receive ORKA-002 per protocol Induction regimen.

placebo comparator: (Induction Period - Arm 4) Placebo

Participants will receive Placebo per protocol Induction regimen.

Interventions

ORKA-002

ORKA-002 administered by subcutaneous (SC) injection

Placebo

Placebo administered by subcutaneous (SC) injection

Primary outcome measure

Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 [ Time Frame: Week 16 ]
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs) [ Time Frame: Day 1 through Week 48 ]

Central Contacts and Locations

Central contacts

Oruka Clinical Trials Information

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information