NCT07474792|RecruitingPhase 2DMCFDA Drug

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

A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis

Oruka Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

ORKA-002-212

Study Type

interventional

Target

160

Locations

2 countries

Sites

Timeline

RegisteredMar 2026

StartedMar 2026

CompletionApr 2029

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P75+ for phase_2

Timeline

32mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach

2 countries

34 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress12%

Mar 2026Apr 2029

First Submitted

Initial submission to the registry

March 11, 2026

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed

3 days until next milestone

Study Start

First participant enrolled

March 19, 2026

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

March 11, 2026

Last Update Submit

July 8, 2026

Conditions

Plaque Psoriasis

Keywords

Phase 2Plaque psoriasisORKA-002

Outcome Measures

Primary Outcomes (2)

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).
Week 16
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Day 1 through Week 48

Secondary Outcomes (4)

Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16
Week 16
Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16
Week 16
Proportion of Participants Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at Week 16
Week 16
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Day 1 through Week 48

Study Arms (4)

(Induction Period - Arm 1) ORKA-002

EXPERIMENTAL

Participants will receive ORKA-002 per protocol Induction regimen.

Drug: ORKA-002

(Induction Period - Arm 2) ORKA-002

EXPERIMENTAL

Participants will receive ORKA-002 per protocol Induction regimen.

Drug: ORKA-002

(Induction Period - Arm 3) ORKA-002

EXPERIMENTAL

Participants will receive ORKA-002 per protocol Induction regimen.

Drug: ORKA-002

(Induction Period - Arm 4) Placebo

PLACEBO COMPARATOR

Participants will receive Placebo per protocol Induction regimen.

Other: Placebo

Interventions

ORKA-002DRUG

ORKA-002 administered by subcutaneous (SC) injection

(Induction Period - Arm 1) ORKA-002(Induction Period - Arm 2) ORKA-002(Induction Period - Arm 3) ORKA-002

PlaceboOTHER

Placebo administered by subcutaneous (SC) injection

(Induction Period - Arm 4) Placebo

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants ≥ 18 and \< 80 years of age at the time of consent
Have a diagnosis of plaque psoriasis for \> 6 months
Have moderate-to-severe chronic plaque psoriasis defined as:
BSA ≥ 10%, and
PASI ≥ 12, and
IGA score of ≥ 3 on a 5-point scale
Candidate for systemic therapy or phototherapy
Women of childbearing potential must have a negative pregnancy test

You may not qualify if:

Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)
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
History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
A known hypersensitivity to any components of the ORKA-002 drug product
Women who are breastfeeding or plan to breastfeed during the study

Contact the study team to confirm eligibility.