A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2)

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 and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE-2)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Remibrutinib Dose A; Drug: Remibrutinib Dose B; Drug: Placebo 1; Drug: Placebo 2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1012AAY
    • Novartis Investigative Site
  • Caba, Argentina, C1205AAO
    • Novartis Investigative Site
  • Córdoba, Argentina, B5000
    • Novartis Investigative Site
• Austria
  • Linz, Austria, 4020
    • Novartis Investigative Site
• Belgium
  • Liège, Belgium, 4000
    • Novartis Investigative Site
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1070
      • Novartis Investigative Site
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Novartis Investigative Site
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3L1
      • Novartis Investigative Site
    • Québec, Quebec, Canada, G1V 4T3
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Novartis Investigative Site
• Colombia
  • Medellín, Colombia, 050012
    • Novartis Investigative Site
  • Antioquia
    • Medellín, Antioquia, Colombia, 050010
      • Novartis Investigative Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 111411
      • Novartis Investigative Site
    • Bogota, Cundinamarca, Colombia, 110221
      • Novartis Investigative Site
• Czechia
  • Karlovy Vary, Czechia, 360 01
    • Novartis Investigative Site
  • Plzen Bolevec, Czechia, 32300
    • Novartis Investigative Site
  • Prague, Czechia, 128 08
    • Novartis Investigative Site
  • Prague, Czechia, 100 34
    • Novartis Investigative Site
  • Prague, Czechia, 150 06
    • Novartis Investigative Site
  • Prague, Czechia, 180 81
    • Novartis Investigative Site
• France
  • Brest, France, 29609
    • Novartis Investigative Site
  • La Rochelle, France, 17019
    • Novartis Investigative Site
  • Lyon, France, 69003
    • Novartis Investigative Site
  • Nice, France, 06000
    • Novartis Investigative Site
  • Reims, France, 51100
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
• Germany
  • Bad Bentheim, Germany, 48455
    • Novartis Investigative Site
  • Berlin, Germany, 13595
    • Novartis Investigative Site
  • Dortmund, Germany, 44137
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Lübeck, Germany, 23538
    • Novartis Investigative Site
  • Minden, Germany, 32429
    • Novartis Investigative Site
  • München, Germany, 80377
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Novartis Investigative Site
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Novartis Investigative Site
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Novartis Investigative Site
  • Saarland
    • Merzig, Saarland, Germany, 66663
      • Novartis Investigative Site
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 161 21
    • Novartis Investigative Site
  • Chaïdári, Greece, 124 62
    • Novartis Investigative Site
  • Thessaloniki, Greece, 564 03
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, H-1083
    • Novartis Investigative Site
  • Budapest, Hungary, 1036
    • Novartis Investigative Site
  • Kecskemét, Hungary, 6001
    • Novartis Investigative Site
  • Szeged, Hungary, 6725
    • Novartis Investigative Site
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Novartis Investigative Site
  • Hajdu Bihar Megye
    • Debrecen, Hajdu Bihar Megye, Hungary, 4032
      • Novartis Investigative Site
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4031
      • Novartis Investigative Site
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • Novartis Investigative Site
  • Selangor Darul Ehsan, Malaysia, 68100
    • Novartis Investigative Site
  • Wilayah Persekutuan, Malaysia, 62502
    • Novartis Investigative Site
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Novartis Investigative Site
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Novartis Investigative Site
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Novartis Investigative Site
• Mexico
  • Durango, Mexico, 34000
    • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Novartis Investigative Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Novartis Investigative Site
• Poland
  • Warsaw, Poland, 02-962
    • Novartis Investigative Site
  • Warsaw, Poland, 02-507
    • Novartis Investigative Site
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Novartis Investigative Site
• Puerto Rico
  • Carolina, Puerto Rico, 00985
    • Alma Cruz-Santana Private Practice
• Romania
  • Bucharest, Romania, 010825
    • Novartis Investigative Site
  • Timișoara, Romania, 300188
    • Novartis Investigative Site
  • District 2
    • Bucharest, District 2, Romania, 020762
      • Novartis Investigative Site
    • Bucharest, District 2, Romania, 020125
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Granollers, Spain, 08402
    • Novartis Investigative Site
  • Las Palmas GC, Spain, 35010
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28002
    • Novartis Investigative Site
  • Pontevedra, Spain, 36003
    • Novartis Investigative Site
  • Seville, Spain, 41009
    • Novartis Investigative Site
  • Valencia, Spain, 46026
    • Novartis Investigative Site
  • Andalusia
    • Granada, Andalusia, Spain, 18014
      • Novartis Investigative Site
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07120
      • Novartis Investigative Site
• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35100
    • Novartis Investigative Site
  • Kecioren Ankara, Turkey (Türkiye), 06010
    • Novartis Investigative Site
  • Balcova
    • Izmir, Balcova, Turkey (Türkiye), 35340
      • Novartis Investigative Site
  • Bilkent-Cankaya
    • Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
      • Novartis Investigative Site
  • Buca
    • Izmir, Buca, Turkey (Türkiye), 35390
      • Novartis Investigative Site
  • Efeler
    • Aydin, Efeler, Turkey (Türkiye), 09100
      • Novartis Investigative Site
  • Kinikli
    • Denizli, Kinikli, Turkey (Türkiye), 20070
      • Novartis Investigative Site
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06500
      • Novartis Investigative Site
  • Yenisehir
    • Mersin, Yenisehir, Turkey (Türkiye), 33110
      • Novartis Investigative Site
• United Kingdom
  • Bristol, United Kingdom, BS1 3NU
    • Novartis Investigative Site
  • Cardiff, United Kingdom, CF14 4XW
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London, United Kingdom, SE5 9RS
    • Novartis Investigative Site
  • London, United Kingdom, E1 2AT
    • Novartis Investigative Site
  • Southampton, United Kingdom, SO16 6YD
    • Novartis Investigative Site
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center PC
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • CTT Research
    • Scottsdale, Arizona, United States, 85260
      • Ctr Dermatology and Plastic Surgery
  • California
    • Fremont, California, United States, 95438
      • Ctr for Dermatology Clinical Res
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • San Diego, California, United States, 92103
      • MedDerm Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Driven Research
    • Miami, Florida, United States, 33179
      • Floridian Research Institute
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Res Ctr
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory School of Med Dermatology
    • Atlanta, Georgia, United States, 30331
      • Atlanta Biomedical Clin Res LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Glenview, Illinois, United States, 60077
      • Endeavor Health
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Southern IN Clinical Trials
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Med Center
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Inst of MI
  • Missouri
    • St Louis, Missouri, United States, 63117
      • Deluxe Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital
    • New York, New York, United States, 10023
      • Cameron Dermatology
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research Boardman
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Fairborn, Ohio, United States, 45324
      • Wright State University
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Ctr of Carolinas
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072-2301
      • Goodlettsville Dermatology Research
  • Texas
    • Humble, Texas, United States, 77346
      • Accurate Clinical Research
    • Pflugerville, Texas, United States, 78660
      • Austin Inst for Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies-Lee
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Care Access Alexandria
    • Danville, Virginia, United States, 24541
      • Complexions Dermatology
    • Vienna, Virginia, United States, 22182
      • Forefront Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remibrutinib Dose B (Treatment Period 1 and 2); Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2	Drug: Remibrutinib Dose B; Remibrutinib Dose B (oral); Other Names: LOU064
Placebo Comparator: Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2); Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2	Drug: Remibrutinib Dose B; Remibrutinib Dose B (oral); Other Names: LOU064; Drug: Placebo 1; Placebo matching to remibrutinib Dose A (oral); Drug: Placebo 2; Placebo matching to remibrutinib Dose B (oral)
Experimental: Remibrutinib Dose A (Treatment Period 1 and 2); articipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2	Drug: Remibrutinib Dose A; Remibrutinib Dose A (oral); Other Names: LOU064

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16	AN50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline	Week 16
Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16	The IHS4 is a disease severity scoring system developed by the European Hidradenitis Suppurativa Foundation. It is a weighted sum of different types of inflammatory lesion counts, calculated as 1 x number of nodules + 2 x number of abscesses + 4 x number of draining tunnels (=fistulae=sinuses).	From baseline up to Week 16
Proportion of participants with HiSCR75 response at Week 16	HiSCR75 is defined as at least a 75% 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
Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16	Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.	Up to Week 16
Proportion of participants with HiSCR50 response at Week 8	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 8
Proportion of participants with HiSCR90 response at Week 16	HiSCR90 is defined as at least a 90% 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
Proportion of participants with clinical response in HS related skin pain (NRS 30), at worst at Week 16	Achievement of NRS30 at Week 16, among participants with baseline NRS ≥ 3 (pooled data from studies CLOU064J12301 and CLOU064J12302). NRS30 is defined as at least a 30% reduction and at least 2-unit reduction from baseline in Patient's Global Assessment of Skin Pain - at worst over the past 7 days.	Week 16
Incidence of treatment emergent adverse events and serious adverse events during the study	The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.	From randomization to end of study, assessed up to 72 weeks.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): October 21, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HS; Hidradenitis Suppurativa; remibrutinib; LOU064; HiSCR; Bruton's tyrosine kinase (BTK) inhibitor; Inflammatory skin disease; Hidradenitis Suppurativa clinical response; Hidradenitides, Suppurativa; Hidradenitis, Suppurativa; Suppurativa Hidradenitides; Suppurativa Hidradenitis; Acne inversa,; Verneuil disease; Chronic skin condition
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Hidradenitis; Dermatitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; remibrutinib
• Other Study ID Numbers: CLOU064J12302; 2024-513266-19-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No