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Can a new injection quiet the painful lumps of hidradenitis suppurativa?

NCT ID NCT07783542

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This trial tests an investigational drug called ORKA-002 in adults with moderate-to-severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps and tunnels under the skin. Participants receive either ORKA-002 or a placebo by injection, and researchers measure whether the drug reduces the number of abscesses and inflammatory nodules by at least 75% after 16 weeks. The study aims to see if ORKA-002 is safe, tolerable, and effective for people who have not responded well to antibiotics.

What this could mean

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

Active substance
ORKA-002, an investigational drug given by injection under the skin
What this could lead to
If successful, ORKA-002 could offer a new treatment option to reduce painful skin lesions in people with moderate-to-severe hidradenitis suppurativa.
What could go wrong
This is an early Phase 2 trial, so results may not hold up in larger studies. The drug's safety and effectiveness are not yet proven, and side effects are possible.

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 200 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 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. Has signs and symptoms of HS for at least 6 months; 2. Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III; 3. Has a history of inadequate response to systemic antibiotic treatment for HS, exhibited recurrence of HS symptoms after discontinuation of systemic antibiotics for HS, demonstrated intolerance to systemic antibiotics for HS, or has a contraindication to systemic antibiotics for HS Exclusion Criteria: 1. Presence of any other active skin disease or condition that may interfere with the assessment of HS; 2. Diagnosis or suspected diagnosis of autoimmune diseases or inflammatory conditions other than HS

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

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

Hidradenitis suppurativa (HS)

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

    2 sites. 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

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27516, United States

    Contact Email: •••••@•••••

  • Oruka Therapeutics Investigative Site

    RECRUITING

    Dallas, Texas, 75246, United States

    Contact Email: •••••@•••••

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