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New pill shows promise for controlling painful skin condition in long-term trial

NCT ID NCT07665437

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This phase 3 study tests the long-term safety and effectiveness of remibrutinib, an oral drug, in 710 adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful abscesses. Participants have already completed a prior remibrutinib study. The trial compares two doses and tracks side effects and reduction in skin lesions 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
remibrutinib (oral drug)
What this could lead to
If successful, this could provide a new long-term treatment option to control painful skin abscesses and inflammation in hidradenitis suppurativa.
What could go wrong
This is an extension study, so participants already tolerated the drug, but long-term safety and effectiveness are still being confirmed. Results may not apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 710 people

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

Started

Jul 2026

Expected to finish

Oct 2031

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 100 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.

Key Inclusion Criteria: * Signed informed consent must be obtained before any assessment is performed. * Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302). * Participant does not meet any treatment discontinuation criteria of the core study at Week 68. Key Exclusion Criteria: * Ongoing or planned use of prohibited HS or non-HS treatments. * Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator. * Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    20 sites in 4 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Apex Clinical Research Center LLC

    RECRUITING

    Mayfield Heights, Ohio, 44124, United States

  • Cameron Dermatology

    RECRUITING

    New York, New York, 10023, United States

  • Clinical Research Ctr of Carolinas

    RECRUITING

    Charleston, South Carolina, 29407, United States

  • Clinical Trials Research Institute

    RECRUITING

    Thousand Oaks, California, 91320, United States

  • Ctr for Dermatology Clinical Res

    RECRUITING

    Fremont, California, 95438, United States

  • Dundee Dermatology

    RECRUITING

    West Dundee, Illinois, 60118, United States

  • Endeavor Health

    RECRUITING

    Glenview, Illinois, 60077, United States

  • Johnson Dermatology

    RECRUITING

    Fort Smith, Arkansas, 72916, United States

  • Novartis Investigative Site

    RECRUITING

    Caba, Buenos Aires, C1119ACN, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1425BEA, Argentina

  • Novartis Investigative Site

    RECRUITING

    Rosario, Santa Fe Province, S2000DBS, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, C1428DZF, Argentina

  • Novartis Investigative Site

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6H 5L5, Canada

  • Olive View UCLA Medical Center

    RECRUITING

    Sylmar, California, 91342, United States

  • Optima Research Boardman

    RECRUITING

    Boardman, Ohio, 44512, United States

  • Skin Specialists PC

    RECRUITING

    Omaha, Nebraska, 68144, United States

  • Southern IN Clinical Trials

    RECRUITING

    New Albany, Indiana, 47150, United States

  • USC Keck School of Medicine

    RECRUITING

    Los Angeles, California, 90033, United States

More trials for these conditions

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