A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

NCT06840392 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064J123022024-513266-19-00
• Study Type: interventional
• Target: 555
• Locations: 19 countries
• Sites: 138

Brief Summary

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

Conditions

Hidradenitis Suppurativa

Keywords

Bruton's tyrosine kinase (BTK) inhibitor; Hidradenitis Suppurativa; HS; Hidradenitis Suppurativa clinical response; HiSCR; remibrutinib; LOU064; Hidradenitides, Suppurativa; Hidradenitis, Suppurativa; Suppurativa Hidradenitides; Suppurativa Hidradenitis; Acne inversa,; Verneuil disease; Inflammatory skin disease; Chronic skin condition

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16

  HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.

  Week 16

Secondary Outcomes (8)

• Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16

  Week 16

• Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16

  From baseline up to Week 16

• Proportion of participants with HiSCR75 response at Week 16

  Week 16

• Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16

  Up to Week 16

• Proportion of participants with HiSCR50 response at Week 8

  Week 8

Study Arms (3)

Remibrutinib Dose A (Treatment Period 1 and 2)

EXPERIMENTAL

articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2

Drug: Remibrutinib Dose A

Remibrutinib Dose B (Treatment Period 1 and 2)

EXPERIMENTAL

Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2

Drug: Remibrutinib Dose B

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

PLACEBO COMPARATOR

Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2

Drug: Remibrutinib Dose B; Drug: Placebo 1; Drug: Placebo 2

Interventions

Remibrutinib Dose A DRUG

Remibrutinib Dose A (oral)

Also known as: LOU064

Remibrutinib Dose A (Treatment Period 1 and 2)

Remibrutinib Dose B DRUG

Remibrutinib Dose B (oral)

Also known as: LOU064

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2); Remibrutinib Dose B (Treatment Period 1 and 2)

Placebo 1 DRUG

Placebo matching to remibrutinib Dose A (oral)

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

Placebo 2 DRUG

Placebo matching to remibrutinib Dose B (oral)

Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants ≥ 12 years of age at the time of signing of the informed consent.
• Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
• 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)

You may not qualify if:

• Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
• Any active skin disease or conditions that may interfere with the assessment of HS.
• Previous exposure to remibrutinib or other BTK inhibitors.
• 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.
• Significant bleeding risk or coagulation disorders.
• History of gastrointestinal bleeding.
• Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
• History or current hepatic disease.
• 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.
• History of hypersensitivity to any of the study drug constituents.
• 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.
• 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.
• Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (138)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, 35205, United States

RECRUITING

CTT Research

Gilbert, Arizona, 85234, United States

RECRUITING

Ctr Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

RECRUITING

Ctr for Dermatology Clinical Res

Fremont, California, 95438, United States

RECRUITING

USC Keck School of Medicine

Los Angeles, California, 90033, United States

RECRUITING

MedDerm Associates

San Diego, California, 92103, United States

RECRUITING

Driven Research

Coral Gables, Florida, 33134, United States

RECRUITING

Floridian Research Institute

Miami, Florida, 33179, United States

RECRUITING

Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States

RECRUITING

University Of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Emory School of Med Dermatology

Atlanta, Georgia, 30303, United States

RECRUITING

Atlanta Biomedical Clin Res LLC

Atlanta, Georgia, 30331, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Endeavor Health

Glenview, Illinois, 60077, United States

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Dundee Dermatology

West Dundee, Illinois, 60118, United States

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Southern IN Clinical Trials

New Albany, Indiana, 47150, United States

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Beth Israel Deaconess Med Center

Boston, Massachusetts, 02215, United States

RECRUITING

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

RECRUITING

Clinical Research Inst of MI

Chesterfield, Michigan, 48047, United States

RECRUITING

Deluxe Dermatology

St Louis, Missouri, 63117, United States

RECRUITING

Skin Specialists PC

Omaha, Nebraska, 68144, United States

RECRUITING

Vivida Dermatology

Las Vegas, Nevada, 89119, United States

RECRUITING

North Shore University Hospital

New Hyde Park, New York, 11040, United States

RECRUITING

Cameron Dermatology

New York, New York, 10023, United States

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Optima Research Boardman

Boardman, Ohio, 44512, United States

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Ohio State University

Columbus, Ohio, 43210, United States

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Wright State University

Fairborn, Ohio, 45324, United States

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Apex Clinical Research Center LLC

Mayfield Heights, Ohio, 44124, United States

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Clinical Research Ctr of Carolinas

Charleston, South Carolina, 29407, United States

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Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072-2301, United States

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Accurate Clinical Research

Humble, Texas, 77346, United States

RECRUITING

Austin Inst for Clinical Research

Pflugerville, Texas, 78660, United States

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Center for Clinical Studies-Lee

Webster, Texas, 77598, United States

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Care Access Alexandria

Arlington, Virginia, 22206, United States

RECRUITING

Complexions Dermatology

Danville, Virginia, 24541, United States

RECRUITING

Forefront Dermatology

Vienna, Virginia, 22182, United States

RECRUITING

Novartis Investigative Site

Berazategui, Buenos Aires, B1837AVT, Argentina

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Novartis Investigative Site

CABA, C1012AAY, Argentina

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Novartis Investigative Site

Caba, C1205AAO, Argentina

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Novartis Investigative Site

Córdoba, B5000, Argentina

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Novartis Investigative Site

Linz, 4020, Austria

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Novartis Investigative Site

Brussels, Brussels Capital, 1070, Belgium

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Novartis Investigative Site

Woluwe-Saint-Lambert, Brussels Capital, B 1200, Belgium

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Novartis Investigative Site

Leuven, Vlaams Brabant, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Edmonton, Alberta, T6G 1C3, Canada

ACTIVE NOT RECRUITING

Novartis Investigative Site

London, Ontario, N6H 5L5, Canada

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Novartis Investigative Site

Montreal, Quebec, H1Y 3L1, Canada

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Novartis Investigative Site

Québec, Quebec, G1V 4T3, Canada

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Novartis Investigative Site

Sherbrooke, Quebec, J1G 1X9, Canada

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Novartis Investigative Site

Medellín, Antioquia, 050010, Colombia

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Novartis Investigative Site

Bogota, Cundinamarca, 110221, Colombia

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Novartis Investigative Site

Bogota, Cundinamarca, 111411, Colombia

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Novartis Investigative Site

Medellín, 050012, Colombia

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Novartis Investigative Site

Karlovy Vary, 360 01, Czechia

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Novartis Investigative Site

Plzen Bolevec, 32300, Czechia

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Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

Prague, 128 08, Czechia

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Novartis Investigative Site

Prague, 150 00, Czechia

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Novartis Investigative Site

Prague, 150 06, Czechia

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Novartis Investigative Site

Prague, 180 81, Czechia

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Novartis Investigative Site

Brest, 29609, France

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Novartis Investigative Site

La Rochelle, 17019, France

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Novartis Investigative Site

Lyon, 69003, France

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Novartis Investigative Site

Nice, 06000, France

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Novartis Investigative Site

Reims, 51100, France

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Novartis Investigative Site

Rouen, 76031, France

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Novartis Investigative Site

Toulouse, 31400, France

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

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Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

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Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Novartis Investigative Site

Merzig, Saarland, 66663, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

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Novartis Investigative Site

Bad Bentheim, 48455, Germany

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Novartis Investigative Site

Berlin, 13595, Germany

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Novartis Investigative Site

Dessau, 06847, Germany

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Novartis Investigative Site

Dortmund, 44137, Germany

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Novartis Investigative Site

Essen, 45147, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Lübeck, 23538, Germany

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Novartis Investigative Site

Minden, 32429, Germany

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Novartis Investigative Site

München, 80377, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Athens, 161 21, Greece

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Novartis Investigative Site

Chaïdári, 124 62, Greece

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Novartis Investigative Site

Thessaloniki, 564 03, Greece

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Novartis Investigative Site

Pécs, Baranya, 7623, Hungary

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Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Novartis Investigative Site

Debrecen, Hajdú-Bihar, 4031, Hungary

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Novartis Investigative Site

Budapest, 1036, Hungary

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Novartis Investigative Site

Budapest, H-1083, Hungary

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Novartis Investigative Site

Kecskemét, 6001, Hungary

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Novartis Investigative Site

Szeged, 6725, Hungary

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Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Novartis Investigative Site

Ipoh, Perak, 30450, Malaysia

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Novartis Investigative Site

Kota Kinabalu, Sabah, 88586, Malaysia

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Novartis Investigative Site

Johor Bahru, 80100, Malaysia

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Novartis Investigative Site

Selangor Darul Ehsan, 68100, Malaysia

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Novartis Investigative Site

Wilayah Persekutuan, 62502, Malaysia

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Novartis Investigative Site

Monterrey, Nuevo León, 64460, Mexico

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Novartis Investigative Site

Culiacán, Sinaloa, 80020, Mexico

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Novartis Investigative Site

Durango, 34000, Mexico

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Novartis Investigative Site

Warsaw, Masovian Voivodeship, 02-953, Poland

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Novartis Investigative Site

Warsaw, 02-507, Poland

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Novartis Investigative Site

Warsaw, 02-962, Poland

RECRUITING

Alma Cruz-Santana Private Practice

Carolina, 00985, Puerto Rico

RECRUITING

Novartis Investigative Site

Bucharest, District 2, 020125, Romania

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Novartis Investigative Site

Bucharest, District 2, 020762, Romania

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Novartis Investigative Site

Bucharest, 010825, Romania

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Novartis Investigative Site

Timișoara, 300188, Romania

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Novartis Investigative Site

Granada, Andalusia, 18014, Spain

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Novartis Investigative Site

Palma, Balearic Islands, 07120, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Novartis Investigative Site

Granollers, 08402, Spain

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Novartis Investigative Site

Las Palmas GC, 35010, Spain

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Novartis Investigative Site

Madrid, 28002, Spain

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Novartis Investigative Site

Madrid, 28041, Spain

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Novartis Investigative Site

Pontevedra, 36003, Spain

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Novartis Investigative Site

Seville, 41009, Spain

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Novartis Investigative Site

Valencia, 46026, Spain

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Novartis Investigative Site

Izmir, Balcova, 35340, Turkey (Türkiye)

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Novartis Investigative Site

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

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Novartis Investigative Site

Izmir, Buca, 35390, Turkey (Türkiye)

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Novartis Investigative Site

Aydin, Efeler, 09100, Turkey (Türkiye)

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Novartis Investigative Site

Denizli, Kinikli, 20070, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

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Novartis Investigative Site

Mersin, Yenisehir, 33110, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

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Novartis Investigative Site

Kecioren Ankara, 06010, Turkey (Türkiye)

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Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Novartis Investigative Site

Bristol, BS1 3NU, United Kingdom

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Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

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Novartis Investigative Site

London, E1 2AT, United Kingdom

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Novartis Investigative Site

London, SE1 9RT, United Kingdom

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Novartis Investigative Site

London, SE5 9RS, United Kingdom

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Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Dermatitis

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): February 7, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (16); CO (4); AR (4); GR (3); ME (3); RO (4); US (36); ES (10); TU (10); HU (7); FR (7); CZ (7); GB (7); MY (6); BE (4); PL (3); CA (5); PR (1); AU (1)