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New pill could ease painful skin condition

NCT ID NCT06799000

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This phase 3 trial tests an oral drug called remibrutinib in 588 people with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful lumps. The study compares two doses of the drug against a placebo over 68 weeks. The main goal is to see if the drug reduces the number of inflamed nodules and abscesses by at least half after 16 weeks.

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 quality of life.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not work better than placebo, and side effects are possible. 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

588 people

The number who actually took part.

Started

Jan 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

  • Advanced Research Experts

    Nashville, Tennessee, 37211, United States

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117, United States

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401, United States

  • Care Access Hoboken

    Hoboken, New Jersey, 07030, United States

  • Cheryl Effron MD Inc

    Anaheim, California, 92807, United States

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320, United States

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana, 46256, United States

  • Dermat. and Adv. Aesthetics

    Lake Charles, Louisiana, 70605, United States

  • Equity Medical LLC

    Bowling Green, Kentucky, 42104, United States

  • Essential Medical Research

    Tulsa, Oklahoma, 74137, United States

  • Florida Academic Centers Research and Education LLC

    Coral Gables, Florida, 33134, United States

  • Forest Hills Dermatology Group

    New York, New York, 10003, United States

  • Gwinnett Clinical Research Center

    Snellville, Georgia, 30078, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689, United States

  • Howard University College of Medicine

    Washington D.C., District of Columbia, 20060, United States

  • Icahn School Of Med At Mount Sinai

    New York, New York, 10029, United States

  • Illinois Dermatology Institute

    Chicago, Illinois, 60602, United States

  • Immunology-Rheumatology Research

    Suwanee, Georgia, 30024, United States

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916, United States

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006, United States

  • Medical University of South Carolina MUSC

    Charleston, South Carolina, 29425, United States

  • Michigan Center for Rsrch Company

    Clarkston, Michigan, 48346, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEA, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    CABA, C1428DZF, Argentina

  • Novartis Investigative Site

    Phillip, Australian Capital Territory, 2606, Australia

  • Novartis Investigative Site

    Sydney, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3050, Australia

  • Novartis Investigative Site

    Sofia, Bulgaria, 1407, Bulgaria

  • Novartis Investigative Site

    Stara Zagora, Bulgaria, 6000, Bulgaria

  • Novartis Investigative Site

    Sofia, 1407, Bulgaria

  • Novartis Investigative Site

    Surrey, British Columbia, V3V 0C6, Canada

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1E 1V4, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3, Canada

  • Novartis Investigative Site

    Richmond Hill, Ontario, L4C 9M7, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1W 4R4, Canada

  • Novartis Investigative Site

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Changsha, Hunan, 410008, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011, China

  • Novartis Investigative Site

    Xian, Shanxi, 710004, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Beijing, 100144, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760032, Colombia

  • Novartis Investigative Site

    Medellín, 050034, Colombia

  • Novartis Investigative Site

    Roskilde, 4000, Denmark

  • Novartis Investigative Site

    Langenau, Baden-Wurttemberg, 89129, Germany

  • Novartis Investigative Site

    Darmstadt, Hesse, 64283, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108, Germany

  • Novartis Investigative Site

    Berlin, 10789, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bochum, 44791, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Hamburg, 20095, Germany

  • Novartis Investigative Site

    Hanover, 30159, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    Thessaloniki, 546 43, Greece

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Catania, CT, 95123, Italy

  • Novartis Investigative Site

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    Florence, FI, 50122, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Muar town, Johor, 84000, Malaysia

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44340, Mexico

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650, Mexico

  • Novartis Investigative Site

    Cuauhtémoc, Mexico City, 06100, Mexico

  • Novartis Investigative Site

    Chihuahua City, 31203, Mexico

  • Novartis Investigative Site

    Bydgoszcz, 85-094, Poland

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Lodz, 90-436, Poland

  • Novartis Investigative Site

    Almada, 2805-267, Portugal

  • Novartis Investigative Site

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    Coimbra, 3004-561, Portugal

  • Novartis Investigative Site

    Lisbon, 1169-050, Portugal

  • Novartis Investigative Site

    Lisbon, 1998-018, Portugal

  • Novartis Investigative Site

    Porto, 4099-001, Portugal

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    Bratislava, 811 09, Slovakia

  • Novartis Investigative Site

    Bratislava, 813 69, Slovakia

  • Novartis Investigative Site

    Prešov, 080 01, Slovakia

  • Novartis Investigative Site

    Raslouw Centurion, Gauteng, 0157, South Africa

  • Novartis Investigative Site

    Soweto, Gauteng, 2013, South Africa

  • Novartis Investigative Site

    Cape Town, 7505, South Africa

  • Novartis Investigative Site

    Durban, 4058, South Africa

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009, Spain

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Manises, Valencia, 46940, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46017, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Valencia, 46014, Spain

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Olive View UCLA Medical Center

    Sylmar, California, 91342, United States

  • OnSite Clinical Solutions LLC

    Huntersville, North Carolina, 28078, United States

  • Physioseq

    Sacramento, California, 95826, United States

  • RFSA Dermatology

    San Antonio, Texas, 78213, United States

  • Revival Research Institute

    Troy, Michigan, 48084, United States

  • Revival Research Institute LLC

    Evans, Georgia, 30809, United States

  • Skinsearch of Rochester Inc

    Rochester, New York, 14623, United States

  • UP Medical Center H System

    Pittsburgh, Pennsylvania, 15213-3403, United States

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

  • University of MiamiHealth System

    Miami, Florida, 33125, United States

  • University of Mississippi Med Ctr

    Jackson, Mississippi, 39216, United States

  • Virginia Clinical Research

    Norfolk, Virginia, 23507, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104, United States

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162, United States

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