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New pill could ease painful skin condition

NCT ID NCT06840392

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This phase 3 study tests an oral drug called remibrutinib in 565 people with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful lumps. Participants receive one of two doses of remibrutinib or a placebo for 68 weeks. The main goal is to see if the drug reduces the number of inflamed nodules and abscesses by at least half at week 16.

What this could mean

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

Active substance
remibrutinib (an oral drug that targets inflammation)
What this could lead to
If it works, this could provide a new oral treatment option for people with moderate to severe hidradenitis suppurativa, reducing painful flare-ups and improving daily life.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects could occur. It is not a cure, and ongoing treatment may be 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 3

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

Participants

565 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Oct 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

12 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: 1. Male and female participants ≥ 12 years of age at the time of signing of the informed consent. 2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit. 3. Participants with moderate to severe HS defined as: * A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND * Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae) Key Exclusion Criteria: 1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline. 2. Any active skin disease or conditions that may interfere with the assessment of HS. 3. Previous exposure to remibrutinib or other BTK inhibitors. 4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer. 5. Significant bleeding risk or coagulation disorders. 6. History of gastrointestinal bleeding. 7. Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication. 8. History or current hepatic disease. 9. Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant. 10. History of hypersensitivity to any of the study drug constituents. 11. Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility. 12. History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment. 13. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

dermatitis hidradenitis hidradenitis suppurativa

As listed by the trial registrant

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

Hidradenitis suppurativa

Contacts and locations

Locations

  • Accurate Clinical Research

    Humble, Texas, 77346, United States

  • Alma Cruz-Santana Private Practice

    Carolina, 00985, Puerto Rico

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio, 44124, United States

  • Atlanta Biomedical Clin Res LLC

    Atlanta, Georgia, 30331, United States

  • Austin Inst for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215, United States

  • CTT Research

    Gilbert, Arizona, 85234, United States

  • Cameron Dermatology

    New York, New York, 10023, United States

  • Care Access Alexandria

    Arlington, Virginia, 22206, United States

  • Center for Clinical Studies-Lee

    Webster, Texas, 77598, United States

  • Clinical Research Ctr of Carolinas

    Charleston, South Carolina, 29407, United States

  • Clinical Research Inst of MI

    Chesterfield, Michigan, 48047, United States

  • Complexions Dermatology

    Danville, Virginia, 24541, United States

  • Ctr for Dermatology Clinical Res

    Fremont, California, 95438, United States

  • Deluxe Dermatology

    St Louis, Missouri, 63117, United States

  • Driven Research

    Miami, Florida, 33126, United States

  • Dundee Dermatology

    West Dundee, Illinois, 60118, United States

  • Emory School of Med Dermatology

    Atlanta, Georgia, 30303, United States

  • Endeavor Health

    Glenview, Illinois, 60077, United States

  • Floridian Research Institute

    Miami, Florida, 33179, United States

  • Forefront Dermatology

    Vienna, Virginia, 22182, United States

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072-2301, United States

  • MedDerm Associates

    San Diego, California, 92103, United States

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135, United States

  • North Shore University Hospital

    New Hyde Park, New York, 11040, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Córdoba, Córdoba Province, B5000, Argentina

  • Novartis Investigative Site

    CABA, C1012AAY, Argentina

  • Novartis Investigative Site

    Caba, C1205AAO, Argentina

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Brussels, Brussels Capital, 1070, Belgium

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3, Canada

  • Novartis Investigative Site

    London, Ontario, N6H 5L5, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H1Y 3L1, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1V 4T3, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 1X9, Canada

  • Novartis Investigative Site

    Medellín, Antioquia, 050010, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 111411, Colombia

  • Novartis Investigative Site

    Medellín, 050012, Colombia

  • Novartis Investigative Site

    Karlovy Vary, 360 01, Czechia

  • Novartis Investigative Site

    Plzen Bolevec, 32300, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Prague, 180 81, Czechia

  • Novartis Investigative Site

    Nice, France, 06000, France

  • Novartis Investigative Site

    Brest, 29609, France

  • Novartis Investigative Site

    La Rochelle, 17019, France

  • Novartis Investigative Site

    Lyon, 69003, France

  • Novartis Investigative Site

    Reims, 51100, France

  • Novartis Investigative Site

    Rouen, 76031, France

  • Novartis Investigative Site

    Toulouse, 31400, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    Merzig, Saarland, 66663, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Bad Bentheim, 48455, Germany

  • Novartis Investigative Site

    Berlin, 13595, Germany

  • Novartis Investigative Site

    Dortmund, 44137, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Minden, 32429, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Athens, 161 21, Greece

  • Novartis Investigative Site

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    Thessaloniki, 564 03, Greece

  • Novartis Investigative Site

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdú-Bihar, 4031, Hungary

  • Novartis Investigative Site

    Budapest, 1036, Hungary

  • Novartis Investigative Site

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    Kecskemét, 6001, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Ipoh, Perak, 30450, Malaysia

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Novartis Investigative Site

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    Selangor Darul Ehsan, 68100, Malaysia

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502, Malaysia

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80020, Mexico

  • Novartis Investigative Site

    Durango, 34000, Mexico

  • Novartis Investigative Site

    Warsaw, Masovian Voivodeship, 02-953, Poland

  • Novartis Investigative Site

    Warsaw, 02-507, Poland

  • Novartis Investigative Site

    Warsaw, 02-962, Poland

  • Novartis Investigative Site

    Bucharest, District 2, 020125, Romania

  • Novartis Investigative Site

    Bucharest, District 2, 020762, Romania

  • Novartis Investigative Site

    Bucharest, 010825, Romania

  • Novartis Investigative Site

    Timișoara, 300188, Romania

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Palma, Balearic Islands, 07120, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Granollers, 08402, Spain

  • Novartis Investigative Site

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    Madrid, 28002, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Pontevedra, 36003, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Izmir, Balcova, 35340, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, Buca, 35390, Turkey (Türkiye)

  • Novartis Investigative Site

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Denizli, Kinikli, 20070, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Kecioren Ankara, 06010, Turkey (Türkiye)

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS7 4SA, United Kingdom

  • Novartis Investigative Site

    Bristol, BS1 3NU, United Kingdom

  • Novartis Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    London, E1 2AT, United Kingdom

  • Novartis Investigative Site

    London, SE1 9RT, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    Southampton, SO16 6YD, United Kingdom

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Optima Research Boardman

    Boardman, Ohio, 44512, United States

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239, United States

  • Skin Specialists PC

    Omaha, Nebraska, 68144, United States

  • Southern IN Clinical Trials

    New Albany, Indiana, 47150, United States

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama, 35205, United States

  • USC Keck School of Medicine

    Los Angeles, California, 90033, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • Vivida Dermatology

    Las Vegas, Nevada, 89119, United States

  • Wright State University

    Fairborn, Ohio, 45324, United States

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