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

Last Update: Jul 29, 2025

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

ClinicalTrials.gov Identifier:

NCT06799000

Novartis Reference Number:CLOU064J12301

See if you Pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).

Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Condition

Hidradenitis Suppurativa

Phase

Phase3

Overall Status

Recruiting

Number of Participants

555

Start Date

Jan 31, 2025

Completion Date

Oct 20, 2028

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Placebo 1

Placebo matching to remibrutinib Dose A (oral)

Drug

Placebo 2

Placebo matching to remibrutinib Dose B (oral)

Drug

Remibrutinib Dose A

Remibrutinib Dose A (oral)

Drug

Remibrutinib Dose B

Remibrutinib Dose B (oral)

Eligibility Criteria

Key Inclusion Criteria:

1. Male and female participants ≥ 18 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.

Novartis Investigative Site

Recruiting

Ciudad Autonoma de Bs As,Buenos Aires,C1119acn,Argentina

Novartis Investigative Site

Recruiting

Ciudad Autonoma de Bs As,C1428azf,Argentina

Novartis Investigative Site

Recruiting

CABA,Buenos Aires,C1425bea,Argentina

Novartis Investigative Site

Recruiting

Santa Fe,Rosario,S2000dbs,Argentina

Novartis Investigative Site

Recruiting

Darlinghurst,2010,Australia

Novartis Investigative Site

Recruiting

Melbourne,Victoria,3004,Australia

Novartis Investigative Site

Recruiting

Phillip,Australian Capital Territory,2606,Australia

Novartis Investigative Site

Recruiting

Westmead,New South Wales,2145,Australia

Novartis Investigative Site

Recruiting

Parkville,Victoria,3050,Australia

Novartis Investigative Site

Recruiting

Sofia,1407,Bulgaria

Novartis Investigative Site

Recruiting

Stara Zagora,6000,Bulgaria

Novartis Investigative Site

Recruiting

Pleven,5800,Bulgaria

Novartis Investigative Site

Recruiting

Hamilton,Ontario,L8l 3c3,Canada

Novartis Investigative Site

Recruiting

Richmond Hill,Ontario,L4c 9m7,Canada

Novartis Investigative Site

Recruiting

Québec,Quebec,G1w 4r4,Canada

Novartis Investigative Site

Recruiting

Surrey,British Columbia,V3v 0c6,Canada

Novartis Investigative Site

Recruiting

St. John's,Newfoundland and Labrador,A1e 1v4,Canada

Novartis Investigative Site

Recruiting

Beijing,100043,China

Novartis Investigative Site

Recruiting

Wuhan,Hubei,430022,China

Novartis Investigative Site

Recruiting

Chengdu,Sichuan,610041,China

Novartis Investigative Site

Recruiting

Jinan,250012,China

Novartis Investigative Site

Recruiting

Zhejiang,315016,China

Novartis Investigative Site

Recruiting

Kobenhavn N V,2400,Denmark

Novartis Investigative Site

Recruiting

Roskilde,4000,Denmark

Novartis Investigative Site

Recruiting

Dresden,01307,Germany

Novartis Investigative Site

Recruiting

Langenau,Baden-Wurttemberg,89129,Germany

Novartis Investigative Site

Recruiting

Darmstadt,Hesse,64283,Germany

Novartis Investigative Site

Recruiting

Halle,Saxony-Anhalt,06108,Germany

Novartis Investigative Site

Recruiting

Berlin,10789,Germany

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Bochum,44791,Germany

Novartis Investigative Site

Recruiting

Kiel,24105,Germany

Novartis Investigative Site

Recruiting

Mainz,55131,Germany

Novartis Investigative Site

Recruiting

Münster,48149,Germany

Novartis Investigative Site

Recruiting

Bonn,53105,Germany

Novartis Investigative Site

Recruiting

Erlangen,91054,Germany

Novartis Investigative Site

Recruiting

Hamburg,20095,Germany

Novartis Investigative Site

Recruiting

Hanover,30159,Germany

Novartis Investigative Site

Recruiting

Heraklion Crete,71110,Greece

Novartis Investigative Site

Recruiting

Chaïdári,Attica,12462,Greece

Novartis Investigative Site

Recruiting

Florence,FI,50122,Italy

Novartis Investigative Site

Recruiting

Roma,RM,00168,Italy

Novartis Investigative Site

Recruiting

Ancona,AN,60126,Italy

Novartis Investigative Site

Recruiting

Brescia,BS,25123,Italy

Novartis Investigative Site

Recruiting

Cona,FE,44100,Italy

Novartis Investigative Site

Recruiting

Milan,MI,20122,Italy

Novartis Investigative Site

Recruiting

Rozzano,MI,20089,Italy

Novartis Investigative Site

Recruiting

Pisa,PI,56124,Italy

Novartis Investigative Site

Recruiting

Muar town,Johor,84000,Malaysia

Novartis Investigative Site

Recruiting

Kota Bharu,Kelantan,15586,Malaysia

Novartis Investigative Site

Recruiting

Kuching,Sarawak,93586,Malaysia

Novartis Investigative Site

Recruiting

Kuala Terengganu,Terengganu,20400,Malaysia

Novartis Investigative Site

Recruiting

Kuala Lumpur,59100,Malaysia

Novartis Investigative Site

Recruiting

George Town,Pulau Pinang,10450,Malaysia

Novartis Investigative Site

Recruiting

Cuauhtémoc,Mexico City,06100,Mexico

Novartis Investigative Site

Recruiting

Guadalajara,Jalisco,03100,Mexico

Novartis Investigative Site

Recruiting

Guadalajara,Jalisco,44650,Mexico

Novartis Investigative Site

Recruiting

Chihuahua City,31203,Mexico

Novartis Investigative Site

Recruiting

Bydgoszcz,85-094,Poland

Novartis Investigative Site

Recruiting

Gdansk,80-214,Poland

Novartis Investigative Site

Recruiting

Lodz,90-436,Poland

Novartis Investigative Site

Recruiting

Almada,2805-267,Portugal

Novartis Investigative Site

Recruiting

Braga,4710243,Portugal

Novartis Investigative Site

Recruiting

Lisbon,1998-018,Portugal

Novartis Investigative Site

Recruiting

Bratislava,81109,Slovakia

Novartis Investigative Site

Recruiting

Prešov,08001,Slovakia

Novartis Investigative Site

Recruiting

Trnava,91702,Slovakia

Novartis Investigative Site

Recruiting

Raslouw Centurion,Gauteng,0157,South Africa

Novartis Investigative Site

Recruiting

Durban,4058,South Africa

Novartis Investigative Site

Recruiting

Barcelona,Catalonia,08003,Spain

Novartis Investigative Site

Recruiting

Cadiz,Andalusia,11009,Spain

Novartis Investigative Site

Recruiting

Valencia,Valencia,46017,Spain

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Madrid,28046,Spain

Novartis Investigative Site

Recruiting

Sabadell,Barcelona,08208,Spain

Novartis Investigative Site

Recruiting

Badalona,Catalonia,08916,Spain

Novartis Investigative Site

Recruiting

Manises,Valencia,46940,Spain

Novartis Investigative Site

Recruiting

Valencia,46014,Spain

Novartis Investigative Site

Recruiting

Kaohsiung City,83301,Taiwan

Novartis Investigative Site

Recruiting

Taoyuan District,33305,Taiwan

Johnson Dermatology

Recruiting

Fort Smith,Arkansas,72916,United States