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New psoriasis shot shows promise in early trial

NCT ID NCT07090330

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study tests an experimental drug called ORKA-001 in 80 adults with moderate-to-severe plaque psoriasis. Participants receive either ORKA-001 or a placebo injection, and doctors measure how much skin clears up after 16 weeks. The goal is to see if ORKA-001 is safe and effective enough to move into larger trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORKA-001 (injection)
What this could lead to
If successful, ORKA-001 could offer a new treatment option to clear psoriasis skin lesions for people with moderate-to-severe disease.
What could go wrong
This is an early Phase 2 proof-of-concept study with only 80 participants. It may not show enough benefit or could have side effects, and larger trials are needed.

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 80 people

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

Started

Jul 2025

Expected to finish

May 2027

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 years and older

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 years of age 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-001 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

Contacts and locations

Locations

  • Oruka Therapeutics Investigative Site

    Fountain Valley, California, 92708, United States

  • Oruka Therapeutics Investigative Site

    Los Angeles, California, 90045, United States

  • Oruka Therapeutics Investigative Site

    San Diego, California, 92123, United States

  • Oruka Therapeutics Investigative Site

    Santa Ana, California, 92701, United States

  • Oruka Therapeutics Investigative Site

    Santa Monica, California, 90403, United States

  • Oruka Therapeutics Investigative Site

    Cromwell, Connecticut, 06416, United States

  • Oruka Therapeutics Investigative Site

    Miami, Florida, 33126, United States

  • Oruka Therapeutics Investigative Site

    Rolling Meadows, Illinois, 60008, United States

  • Oruka Therapeutics Investigative Site

    Bowling Green, Kentucky, 42104, United States

  • Oruka Therapeutics Investigative Site

    Rockville, Maryland, 20850, United States

  • Oruka Therapeutics Investigative Site

    Boston, Massachusetts, 02111, United States

  • Oruka Therapeutics Investigative Site

    Detroit, Michigan, 48202, United States

  • Oruka Therapeutics Investigative Site

    New York, New York, 10023, United States

  • Oruka Therapeutics Investigative Site

    New York, New York, 10029, United States

  • Oruka Therapeutics Investigative Site

    Portland, Oregon, 97201, United States

  • Oruka Therapeutics Investigative Site

    Norfolk, Virginia, 23502, United States

  • Oruka Therapeutics Investigative Site

    Milwaukee, Wisconsin, 53226, United States

  • Oruka Therapeutics Investigative Site

    Edmonton, Alberta, T5J 3S9, Canada

  • Oruka Therapeutics Investigative Site

    Edmonton, Alberta, T6G 1C3, Canada

  • Oruka Therapeutics Investigative Site

    Surrey, British Columbia, V3R 6A7, Canada

  • Oruka Therapeutics Investigative Site

    Hamilton, Ontario, L8N 1Y2, Canada

  • Oruka Therapeutics Investigative Site

    London, Ontario, N6H 5LS, Canada

  • Oruka Therapeutics Investigative Site

    Markham, Ontario, L3P 1X3, Canada

  • Oruka Therapeutics Investigative Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Oruka Therapeutics Investigative Site

    Toronto, Ontario, M4W 2N4, Canada

  • Oruka Therapeutics Investigative Site

    Waterloo, Ontario, N2J 1C4, Canada

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