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New psoriasis drug shows promise in Mid-Stage trial

NCT ID NCT07290569

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 4 times

Summary

This study tests a new medicine called ORKA-001 for adults with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly patches. About 160 participants will receive either the drug or a placebo to see if it can completely clear the skin by week 16. The goal is to find the right dose and check for side effects.

Why investors are watching

Oruka Therapeutics is running a Phase 2 trial of ORKA-001, an experimental drug for moderate-to-severe plaque psoriasis, in 160 adults. The trial compares several doses of the drug against a placebo to see if it clears skin and is safe. For a micro-cap company with few other products, this readout is the main event: it will show whether ORKA-001 works well enough to justify further development and funding.

If it works: If ORKA-001 shows clear benefit over placebo with acceptable safety, Oruka could advance the drug to larger trials or attract a partner to share development costs. A positive result would validate the company's lead asset and give it a path toward a market with many treatment options.

If it fails: If ORKA-001 fails to beat placebo or causes safety problems, Oruka would have little to fall back on, and the stock could lose much of its value. Phase 2 trials often fail, so a negative result is a real possibility that would set the company back significantly.

AI-written from the trial record. Speculative, and not investment advice.

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

Dec 2025

Expected to finish

Dec 2028

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

    Phoenix, Arizona, 85032, United States

  • Oruka Therapeutics Investigative Site

    North Little Rock, Arkansas, 72117, United States

  • Oruka Therapeutics Investigative Site

    Los Angeles, California, 90024, 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

    Miami, Florida, 33126, United States

  • Oruka Therapeutics Investigative Site

    Rolling Meadows, Illinois, 60008, United States

  • Oruka Therapeutics Investigative Site

    Plainfield, Indiana, 46168, United States

  • Oruka Therapeutics Investigative Site

    Rockville, Maryland, 20850, United States

  • Oruka Therapeutics Investigative Site

    Kew Gardens, New York, 11415, United States

  • Oruka Therapeutics Investigative Site

    Chapel Hill, North Carolina, 27516, United States

  • Oruka Therapeutics Investigative Site

    Cleveland, Ohio, 44106, United States

  • Oruka Therapeutics Investigative Site

    Mason, Ohio, 45040, United States

  • Oruka Therapeutics Investigative Site

    Portland, Oregon, 97201, United States

  • Oruka Therapeutics Investigative Site

    Portland, Oregon, 97210, United States

  • Oruka Therapeutics Investigative Site

    Philadelphia, Pennsylvania, 19104, United States

  • Oruka Therapeutics Investigative Site

    Frisco, Texas, 75033, United States

  • Oruka Therapeutics Investigative Site

    Houston, Texas, 77004, United States

  • Oruka Therapeutics Investigative Site

    Webster, Texas, 77598, United States

  • Oruka Therapeutics Investigative Site

    Norfolk, Virginia, 23502, United States

  • Oruka Therapeutics Investigative Site

    Surrey, British Columbia, V3R 6A7, Canada

  • Oruka Therapeutics Investigative Site

    Surrey, British Columbia, V3V 0C6, Canada

  • Oruka Therapeutics Investigative Site

    Fredericton, New Brunswick, E3B 1G9, Canada

  • Oruka Therapeutics Investigative Site

    Ajax, Ontario, L1S 7K8, Canada

  • Oruka Therapeutics Investigative Site

    Markham, Ontario, L3P 1X3, Canada

  • Oruka Therapeutics Investigative Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Oruka Therapeutics Investigative Site

    Montreal, Quebec, HZX 2V1, Canada

  • Oruka Therapeutics Investigative Site

    Québec, Quebec, G1V 4X7, Canada

  • Oruka Therapeutics Investigative Site

    Heidelberg, Baden-Wuerrtemberg, 69120, Germany

  • Oruka Therapeutics Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Oruka Therapeutics Investigative Site

    Bad Bentheim, Lower Saxony, 48455, Germany

  • Oruka Therapeutics Investigative Site

    Kiel, Schleswig-Holstein, 24105, Germany

  • Oruka Therapeutics Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Oruka Therapeutics Investigative Site

    Barcelona, Barcelona, 08041, Spain

  • Oruka Therapeutics Investigative Site

    Madrid, Madrid, 28002, Spain

  • Oruka Therapeutics Investigative Site

    Madrid, Madrid, 28046, Spain

More trials for these conditions

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