Plaque PsoriasisPhase 2EVERLAST-ANCT07090330
ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing ORKA-001 Induction Dose and ORKA-001 Maintenance Dose in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 26 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ORKA-001 Induction Dose and ORKA-001 Maintenance Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 18 Jul 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥ 18 years of age
- 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-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States17 sites
Oruka Therapeutics Investigative Site
Boston, Massachusetts, 02111
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky, 42104
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, 06416
Oruka Therapeutics Investigative Site
Detroit, Michigan, 48202
Oruka Therapeutics Investigative Site
Fountain Valley, California, 92708
Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
Oruka Therapeutics Investigative Site
Miami, Florida, 33126
Oruka Therapeutics Investigative Site
Milwaukee, Wisconsin, 53226
Oruka Therapeutics Investigative Site
New York, New York, 10023
Oruka Therapeutics Investigative Site
New York, New York, 10029
Oruka Therapeutics Investigative Site
Norfolk, Virginia, 23502
Oruka Therapeutics Investigative Site
Portland, Oregon, 97201
Oruka Therapeutics Investigative Site
Rockville, Maryland, 20850
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
Canada9 sites
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T5J 3S9
Oruka Therapeutics Investigative Site
Edmonton, Alberta, T6G 1C3
Oruka Therapeutics Investigative Site
Hamilton, Ontario, L8N 1Y2
Oruka Therapeutics Investigative Site
London, Ontario, N6H 5LS
Oruka Therapeutics Investigative Site
Markham, Ontario, L3P 1X3
Oruka Therapeutics Investigative Site
Peterborough, Ontario, K9J 5K2
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3R 6A7
Oruka Therapeutics Investigative Site
Toronto, Ontario, M4W 2N4
Oruka Therapeutics Investigative Site
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Read the detailed description
This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.
- Conditions
- Plaque Psoriasis
- Being tested
- ORKA-001 Induction Dose, Placebo, ORKA-001 Maintenance Dose
- Keywords
- Phase 2, ORKA-001, Plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKA-001 Induction DoseDrug
ORKA-001 Induction Dose, administered by subcutaneous (SC) injection
PlaceboOther
Placebo administered by subcutaneous (SC) injection
ORKA-001 Maintenance DoseDrug
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| (Induction Period) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Induction regimen. Receives: Drug: ORKA-001 Induction Dose |
| (Induction Period) Placebo | Placebo comparator | Participants will receive Placebo per protocol Induction regimen. Receives: Other: Placebo |
| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. Receives: Drug: ORKA-001 Maintenance Dose |
| (Maintenance Period - Arm 2) ORKA-001 | Experimental | Participants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. Receives: Drug: ORKA-001 Maintenance Dose |
| (Maintenance Period - Arm 3) Placebo | Placebo comparator | Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response. 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
Secondary outcomes (8)
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
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 Maintaining 100% Reduction in PASI Score at Week 52
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 52
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 52
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 52
Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 52
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 52
Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 52
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 52
Incidence of Treatment-emergent Adverse Events
Incidence of treatment adverse events and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Measured: Day 1 through 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start18 Jul 2025
- Primary completion25 Mar 2026
- Study completionMay 2027 (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
- 80 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
- NCT07090330
- Sponsor's protocol ID
- ORKA-001-112
- Acronym
- EVERLAST-A
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07090330
- Acronym / sponsor ID
- EVERLAST-A / ORKA-001-112
- Conditions
- Plaque Psoriasis
- Keywords
- Phase 2, ORKA-001, Plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oruka Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Detailed description
This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| (Induction Period) ORKA-001 | Experimental | Drug: ORKA-001 Induction DoseParticipants will receive ORKA-001 per protocol Induction regimen. |
| (Induction Period) Placebo | Placebo comparator | Other: PlaceboParticipants will receive Placebo per protocol Induction regimen. |
| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Drug: ORKA-001 Maintenance DoseParticipants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
| (Maintenance Period - Arm 2) ORKA-001 | Experimental | Drug: ORKA-001 Maintenance DoseParticipants will receive ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
| (Maintenance Period - Arm 3) Placebo | Placebo comparator | Other: PlaceboParticipants will receive Placebo per protocol Maintenance regimen, based on protocol defined response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for > 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- Candidate for systemic therapy or phototherapy
- Women of childbearing potential must have a negative pregnancy test
Key exclusion criteria (5 listed)
- 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-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORKA-001 Induction DoseORKA-001 Induction Dose, administered by subcutaneous (SC) injection | Drug | (Induction Period) ORKA-001 |
| PlaceboPlacebo administered by subcutaneous (SC) injection | Other | (Induction Period) Placebo, (Maintenance Period - Arm 3) Placebo |
| ORKA-001 Maintenance DoseORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection | Drug | (Maintenance Period - Arm 1) ORKA-001, (Maintenance Period - Arm 2) ORKA-001 |
Primary outcome
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
Time frame: 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).
8 secondary outcomes
Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16
Time frame: Week 16
Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16
Time frame: Week 16
Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16
Time frame: Week 16
Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 52
Time frame: Week 52
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 52
Time frame: Week 52
Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 52
Time frame: Week 52
Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 52
Time frame: Week 52
Incidence of Treatment-emergent Adverse Events
Time frame: Day 1 through 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORKA-001 Induction Dose and ORKA-001 Maintenance Dose in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.