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New psoriasis drug ORKA-001 tested for Long-Term safety

NCT ID NCT07449702

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This study is testing the long-term safety and effectiveness of a drug called ORKA-001 for people with moderate-to-severe plaque psoriasis. It is an open-label extension, meaning everyone gets the drug, and it includes 240 adults who already completed a previous trial with ORKA-001. Researchers will track side effects and how well the drug controls psoriasis over time.

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 (a drug given as an injection under the skin)
What this could lead to
If successful, this could confirm that ORKA-001 is safe and effective for long-term control of moderate-to-severe plaque psoriasis.
What could go wrong
This is an early-phase, open-label extension study with no placebo group, so results may not prove long-term benefit. Side effects are possible, and the drug may not work for everyone.

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 240 people

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

Started

Feb 2026

Expected to finish

Jul 2030

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. Signed informed consent by participants from previous trial choosing to transition into the OLE. 2. Participants who have successfully completed the preceding trial. 3. For women of childbearing potential, 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 contraception Exclusion Criteria: 1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001 2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial. 3. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. 4. Any clinically significant 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. 5. Participant is pregnant or breastfeeding.

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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

    32 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

    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, 33126, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Rolling Meadows, Illinois, 60008, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Bowling Green, Kentucky, 42104, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Rockville, Maryland, 20850, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Boston, Massachusetts, 02111, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    New York, New York, 10023, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    New York, New York, 10029, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Portland, Oregon, 97201, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Portland, Oregon, 97210, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Frisco, Texas, 75033, 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

    Norfolk, Virginia, 23502, 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

    Ajax, Ontario, L1S7K8, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    London, Ontario, N6H 5L5, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Markham, Ontario, L3P 1X3, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Peterborough, Ontario, K9J 5K2, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Toronto, Ontario, M4W 2N4, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Waterloo, Ontario, N2J 1C4, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Montreal, Quebec, H2X2V1, Canada

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Québec, Quebec, G1V4X7, Canada

    Contact Email: •••••@•••••

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