Plaque PsoriasisPhase 2EVERLAST-BNCT07290569
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing ORKA-001 in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 36 sites in 4 countries.
Trial summary
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. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 3 Dec 2025to Dec 2028
- 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
36 sites in 4 countries.
36 sites in 4 countries
United States20 sites
Oruka Therapeutics Investigative Site
Chapel Hill, North Carolina, 27516
Oruka Therapeutics Investigative Site
Cleveland, Ohio, 44106
Oruka Therapeutics Investigative Site
Frisco, Texas, 75033
Oruka Therapeutics Investigative Site
Houston, Texas, 77004
Oruka Therapeutics Investigative Site
Kew Gardens, New York, 11415
Oruka Therapeutics Investigative Site
Los Angeles, California, 90024
Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
Oruka Therapeutics Investigative Site
Mason, Ohio, 45040
Oruka Therapeutics Investigative Site
Miami, Florida, 33126
Oruka Therapeutics Investigative Site
Norfolk, Virginia, 23502
Oruka Therapeutics Investigative Site
North Little Rock, Arkansas, 72117
Oruka Therapeutics Investigative Site
Philadelphia, Pennsylvania, 19104
Oruka Therapeutics Investigative Site
Phoenix, Arizona, 85032
Oruka Therapeutics Investigative Site
Plainfield, Indiana, 46168
Oruka Therapeutics Investigative Site
Portland, Oregon, 97201
Oruka Therapeutics Investigative Site
Portland, Oregon, 97210
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
Webster, Texas, 77598
Canada8 sites
Oruka Therapeutics Investigative Site
Ajax, Ontario, L1S 7K8
Oruka Therapeutics Investigative Site
Fredericton, New Brunswick, E3B 1G9
Oruka Therapeutics Investigative Site
Markham, Ontario, L3P 1X3
Oruka Therapeutics Investigative Site
Montreal, Quebec, HZX 2V1
Oruka Therapeutics Investigative Site
Peterborough, Ontario, K9J 5K2
Oruka Therapeutics Investigative Site
Québec, Quebec, G1V 4X7
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3R 6A7
Oruka Therapeutics Investigative Site
Surrey, British Columbia, V3V 0C6
Germany4 sites
Oruka Therapeutics Investigative Site
Bad Bentheim, Lower Saxony, 48455
Oruka Therapeutics Investigative Site
Frankfurt am Main, Hesse, 60590
Oruka Therapeutics Investigative Site
Heidelberg, Baden-Wuerrtemberg, 69120
Oruka Therapeutics Investigative Site
Kiel, Schleswig-Holstein, 24105
Spain4 sites
Oruka Therapeutics Investigative Site
Badalona, Barcelona, 08916
Oruka Therapeutics Investigative Site
Barcelona, Barcelona, 08041
Oruka Therapeutics Investigative Site
Madrid, Madrid, 28002
Oruka Therapeutics Investigative Site
Madrid, Madrid, 28046
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 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-001 in adult participants with moderate-to-severe plaque psoriasis.
Read the detailed 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.
- Conditions
- Plaque Psoriasis
- Being tested
- ORKA-001, Placebo
- 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-001Drug
ORKA-001 administered by subcutaneous (SC) injection
PlaceboOther
Placebo administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| (Induction Period - Arm 1) ORKA-001 | Experimental | Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen. Receives: Drug: ORKA-001 |
| (Induction Period - Arm 2) ORKA-001 | Experimental | Participants will receive 300 mg ORKA-001 per protocol Induction regimen. Receives: Drug: ORKA-001 |
| (Induction Period - Arm 3) ORKA-001 | Experimental | Participants will receive 600 mg ORKA-001 per protocol Induction regimen. Receives: Drug: ORKA-001 |
| (Induction Period - Arm 4) Placebo | Placebo comparator | Participants will receive Placebo per protocol Induction regimen. Receives: Other: Placebo |
| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. Receives: Drug: ORKA-001 |
| (Maintenance Period - Arm 2) ORKA-001 | Experimental | Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. Receives: Drug: ORKA-001 |
| (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 (9)
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 100
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 100
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100
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 100
Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100
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 100
Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100
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 100
Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100
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 100
Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Measured: Day 1 through Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start3 Dec 2025
- Primary completion21 Oct 2026
- Study completionDec 2028 (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
- NCT07290569
- Sponsor's protocol ID
- ORKA-001-114
- Acronym
- EVERLAST-B
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07290569
- Acronym / sponsor ID
- EVERLAST-B / ORKA-001-114
- Conditions
- Plaque Psoriasis
- Keywords
- Phase 2, ORKA-001, Plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oruka Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Dec 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, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| (Induction Period - Arm 1) ORKA-001 | Experimental | Drug: ORKA-001Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 2) ORKA-001 | Experimental | Drug: ORKA-001Participants will receive 300 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 3) ORKA-001 | Experimental | Drug: ORKA-001Participants will receive 600 mg ORKA-001 per protocol Induction regimen. |
| (Induction Period - Arm 4) Placebo | Placebo comparator | Other: PlaceboParticipants will receive Placebo per protocol Induction regimen. |
| (Maintenance Period - Arm 1) ORKA-001 | Experimental | Drug: ORKA-001Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response. |
| (Maintenance Period - Arm 2) ORKA-001 | Experimental | Drug: ORKA-001Participants will receive 600 mg 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-001ORKA-001 administered by subcutaneous (SC) injection | Drug | (Induction Period - Arm 1) ORKA-001, (Induction Period - Arm 2) ORKA-001, (Induction Period - Arm 3) ORKA-001, (Maintenance Period - Arm 1) ORKA-001, (Maintenance Period - Arm 2) ORKA-001 |
| PlaceboPlacebo administered by subcutaneous (SC) injection | Other | (Induction Period - Arm 4) Placebo, (Maintenance Period - Arm 3) Placebo |
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).
9 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 100
Time frame: Week 100
Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100
Time frame: Week 100
Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100
Time frame: Week 100
Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100
Time frame: Week 100
Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100
Time frame: Week 100
Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Time frame: Day 1 through Week 100
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 6 Nov 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.
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORKA-001 in people with Plaque Psoriasis, run by Oruka Therapeutics, Inc. at 36 sites in 4 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, Germany, Spain. 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 6 Nov 2026.