ClinicalTrials.gg
Enrolling by invitationNCT07933783ORKA-002-213Updated Nov 12, 2026

An Open-label Study With Maintenance Dosing of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 2 interventional study of ORKA-002 in Plaque Psoriasis, sponsored by Oruka Therapeutics, Inc.. Enrolling by invitation at 8 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Oruka Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
18 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 764 studies in Psoriasis with a site in United States — 55 open to participants now, 86 under way, 19 of them phase 3. Psoriasis · United States.

Planned enrollment
234th of 673
160 · median 77
Started
2026
with 15 others
Phase 2
200 of 764
5 open now
Primary completion
2029-07
later than 70 of 85 live
Registered
764th of 764
by date

Among the 764 studies in Psoriasis with a site in United States, this one is the 234th largest by planned enrollment of the 673 interventional ones that give a count, is one of 16 that started in 2026, is one of 200 in phase 2, reaches primary completion later than 70 of the 85 other live ones, and was the 764th registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 277 are open to participants now.

Browse Psoriasis studies →

Open to participants now

55 of the 764 studies in Psoriasis with a site in United States are open now. Recruiting first, the newest first:

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All 55 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 79 Years · all sexes · no healthy volunteers.

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02

Study summary

An open-label study with maintenance dosing to evaluate the long-term safety and efficacy of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

Read the detailed description

This open-label study with maintenance dosing to evaluate the long-term safety and efficacy of ORKA-002 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label maintenance period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last dose of ORKA-002.

03

Conditions studied

  • Plaque Psoriasis

Browse trials for

Keywords

  • Phase 2
  • ORKA-002
  • open label maintenance
04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed by participants from previous trial choosing to transition into the Open-label study.
  2. Participants who have successfully completed the preceding trial.
  3. For women of , must have a negative urine pregnancy test at Baseline visit.
  4. For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective .

Exclusion criteria

Exclusion Criteria:

  1. Participants who experienced any adverse events with ORKA-002 in the preceding trial that led to permanent medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-002.
  2. Participants whom the Investigator feels would not benefit from treatment with open-label ORKA-002.
  3. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
  4. Participants who, while in ORKA-002-212, developed a new intercurrent illness or diagnosis/suspected diagnosis which, in the opinion of the Investigator, indicates that continued treatment and/or participation in the study is not in the participant's best interest.
  5. Any laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
  6. Participant is pregnant or breastfeeding.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    ORKA-002 (High Dose)

    Participants will receive ORKA-002 every 6 moinths per protocol.

    Drug: ORKA-002

  • Experimental
    ORKA-002 (Low Dose)

    Participants will receive ORKA-002 every 6 months per the protocol.

    Drug: ORKA-002

  • Experimental
    ORKA-002 (Mid-Dose)

    Participants will receive ORKA-002 every 6 moinths per the protocol

    Drug: ORKA-002

Interventions

  • ORKA-002 administered by subcutaneous (SC) injection

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs of Special Interest (TEAESIs)

    Incidence of treatment adverse events, serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.

    Time frame: Day 1 through Week 144

Secondary outcomes

  1. Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of Open-label Study

    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).

    Time frame: Day 1 through Week 96

  2. Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of Open-label Study

    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).

    Time frame: Day 1 through Week 96

  3. Proportion of Participants Maintaining PASI75 in the Subset of Participants Meeting the Criterion at Baseline of Open-label Study

    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).

    Time frame: Day 1 to Week 96

  4. Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of Open-label Study

    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).

    Time frame: Day 1 to Week 96

  5. Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of Open-label Study

    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).

    Time frame: Day 1 to Week 96

  6. Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of Open-label Study

    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).

    Time frame: Day 1 to Week 96

  7. Time-to-loss of PASI90 in the Subset of Participants who achieved PASI100 at Baseline of Open-label Study

    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).

    Time frame: Day 1 to Week 96

  8. PASI Score Over Time

    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).

    Time frame: Day 1 to Week 96

  9. IGA Score Over Time

    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).

    Time frame: Day 1 to Week 96

07

Study locations

8 sites
  • Oruka Therapeutics Investigative Site
    Fountain Valley, California 92708, United States
  • Oruka Therapeutics Investigative Site
    Milford, Massachusetts 01757, United States
  • Oruka Therapeutics Investigative Site
    New Brighton, Minnesota 55112, United States
  • Oruka Therapeutics Investigative Site
    Wilmington, North Carolina 28405, United States
  • Oruka Therapeutics Investigative Site
    Warrenton, Oregon 97146, United States
  • Oruka Therapeutics Investigative Site
    Barrie, Ontario L4M 7G1, Canada
  • Oruka Therapeutics Investigative Site
    North Bay, Ontario P1B 3Z7, Canada
  • Oruka Therapeutics Investigative Site
    Toronto, Ontario M5N 1A8, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jul 2029, 32 months after the start.

Of 146 industry-sponsored phase 2 interventional studies under Psoriasis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 20. This study's planned 32 months is above that.

Counting every sponsor, half of 175 studies reached it within 14 months; a quarter within 9 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartActual
Oct 26, 2026
Primary completionEst.
Jul 1, 2029
CompletionEst.
Sep 1, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933783
Lead sponsor
Oruka Therapeutics, Inc.
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Oct 26, 2026
Primary completion
Jul 1, 2029 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: ORKA-002

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