Plaque PsoriasisPhase 2NCT07474792
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing ORKA-002 in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 40 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ORKA-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 40 sitesin 2 countries
- Study dates
- 19 Mar 2026to Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States29 sites
Oruka Therapeutics Investigative Site
Ann Arbor, Michigan, 48109
Oruka Therapeutics Investigative Site
Bexley, Ohio, 43209
Oruka Therapeutics Investigative Site
Birmingham, Alabama, 35203
Oruka Therapeutics Investigative Site
Boston, Massachusetts, 02115
Oruka Therapeutics Investigative Site
Charleston, South Carolina, 29407
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, 06416
Oruka Therapeutics Investigative Site
Dallas, Texas, 75231
Oruka Therapeutics Investigative Site
Dallas, Texas, 75390
Oruka Therapeutics Investigative Site
Detroit, Michigan, 48202
Oruka Therapeutics Investigative Site
Elmhurst, New York, 11373
Oruka Therapeutics Investigative Site
Fountain Valley, California, 92708
Oruka Therapeutics Investigative Site
Houston, Texas, 77004
Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
Oruka Therapeutics Investigative Site
Miami, Florida, 33124
Oruka Therapeutics Investigative Site
Milford, Massachusetts, 01757
Oruka Therapeutics Investigative Site
Mill Creek, Washington, 98012
Oruka Therapeutics Investigative Site
New Brighton, Minnesota, 55112
Oruka Therapeutics Investigative Site
New York, New York, 10029
Oruka Therapeutics Investigative Site
Omaha, Nebraska, 68144
Oruka Therapeutics Investigative Site
Phoenix, Arizona, 85032
Oruka Therapeutics Investigative Site
Portland, Oregon, 97201
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, 60008
Oruka Therapeutics Investigative Site
San Diego, California, 92123
Oruka Therapeutics Investigative Site
Santa Ana, California, 92701
Oruka Therapeutics Investigative Site
Santa Monica, California, 90403
Oruka Therapeutics Investigative Site
Warren, Michigan, 48088
Oruka Therapeutics Investigative Site
Warrenton, Oregon, 97146
Oruka Therapeutics Investigative Site
Webster, Texas, 77598
Oruka Therapeutics Investigative Site
Wilmington, North Carolina, 28405
Canada11 sites
Oruka Therapeutics Investigative Site
Barrie, Ontario, L4M 7G1
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T5J 3S9
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T6G 1C3
Oruka Therapeutics Investigative Site
London, Ontario, N6H 5L5
Oruka Therapeutics Investigative Site
North Bay, Ontario, P1B 3Z7
Oruka Therapeutics Investigative Site
Peterborough, Ontario, K9J 5K2
Oruka Therapeutics Investigative Site
Saskatoon, Saskatchewan, S7K 2C1
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3R 6A7
Oruka Therapeutics Investigative Site
Toronto, Ontario, M5N 1A8
Oruka Therapeutics Investigative Site
Toronto, Ontario, SK S7K 2C1
Oruka Therapeutics Investigative Site
Waterloo, Ontario, N2J 1C4
About this study
Official title: 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
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.
Read the detailed 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
- Conditions
- Plaque Psoriasis
- Being tested
- ORKA-002, Placebo
- Keywords
- Phase 2, Plaque psoriasis, ORKA-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKA-002Drug
ORKA-002 administered by subcutaneous (SC) injection
PlaceboOther
Placebo administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| (Induction Period - Arm 1) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. Receives: Drug: ORKA-002 |
| (Induction Period - Arm 2) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. Receives: Drug: ORKA-002 |
| (Induction Period - Arm 3) ORKA-002 | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. Receives: Drug: ORKA-002 |
| (Induction Period - Arm 4) Placebo | Placebo comparator | Participants will receive Placebo per protocol Induction regimen. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Day 1 through Week 48
Secondary outcomes (4)
Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16
The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Measured: Week 16
Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16
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).
Measured: Week 16
Proportion of Participants Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at Week 16
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).
Measured: Week 16
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs 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
Measured: Day 1 through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start19 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oruka Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474792
- Sponsor's protocol ID
- ORKA-002-212
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided