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New psoriasis drug shows promise in Mid-Stage trial

NCT ID NCT07474792

Symptom relief Sponsor: Oruka Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study tests a new medicine called ORKA-002 for adults with moderate-to-severe plaque psoriasis. About 160 participants will receive either the drug or a placebo to see if it clears skin and is safe. The goal is to find the best dose and check for side effects over 16 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants ≥ 18 and \< 80 years of age at the time of consent 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test Exclusion Criteria: 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis) 2. 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 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence 4. A known hypersensitivity to any components of the ORKA-002 drug product 5. Women who are breastfeeding or plan to breastfeed during the study

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Birmingham, Alabama, 35203, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Phoenix, Arizona, 85032, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Fountain Valley, California, 92708, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Los Angeles, California, 90045, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    San Diego, California, 92123, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Santa Ana, California, 92701, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Santa Monica, California, 90403, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Cromwell, Connecticut, 06416, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Miami, Florida, 33124, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Rolling Meadows, Illinois, 60008, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Milford, Massachusetts, 01757, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Warren, Michigan, 48088, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    New Brighton, Minnesota, 55112, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Omaha, Nebraska, 68144, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Elmhurst, New York, 11373, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    New York, New York, 10029, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Wilmington, North Carolina, 28405, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Bexley, Ohio, 43209, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Portland, Oregon, 97201, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Warrenton, Oregon, 97146, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Charleston, South Carolina, 29407, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Dallas, Texas, 75231, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Houston, Texas, 77004, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Webster, Texas, 77598, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Mill Creek, Washington, 98012, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Edmonton, Alberta, T5J 3S9, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 1C3, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Surrey, British Columbia, V3R 6A7, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Barrie, Ontario, L4M 7G1, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    London, Ontario, N6H 5L5, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    North Bay, Ontario, P1B 3Z7, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Peterborough, Ontario, K9J 5K2, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Toronto, Ontario, SK S7K 2C1, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Waterloo, Ontario, N2J 1C4, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Saskatoon, Saskatchewan, S7K 2C1, Canada

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.