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Hidradenitis SuppurativaPhase 3RECHARGE-2NCT06840392

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

A Phase 3 study testing Remibrutinib Dose A and Remibrutinib Dose B in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 129 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 to 100 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Remibrutinib Dose A and Remibrutinib Dose B
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
565 participants
Where
129 sitesin 19 countries
Study dates
20 Mar 2025to 21 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

129 sites in 19 countries.

129 sites in 19 countries

United States35 sites

  • Care Access Alexandria

    Arlington, Virginia, 22206

  • Emory School of Med Dermatology

    Atlanta, Georgia, 30303

  • Atlanta Biomedical Clin Res LLC

    Atlanta, Georgia, 30331

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama, 35205

  • Optima Research Boardman

    Boardman, Ohio, 44512

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • Clinical Research Ctr of Carolinas

    Charleston, South Carolina, 29407

  • Clinical Research Inst of MI

    Chesterfield, Michigan, 48047

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio State University

    Columbus, Ohio, 43210

  • Complexions Dermatology

    Danville, Virginia, 24541

  • Wright State University

    Fairborn, Ohio, 45324

  • Ctr for Dermatology Clinical Res

    Fremont, California, 95438

  • CTT Research

    Gilbert, Arizona, 85234

  • Endeavor Health

    Glenview, Illinois, 60077

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072-2301

  • Accurate Clinical Research

    Humble, Texas, 77346

  • Vivida Dermatology

    Las Vegas, Nevada, 89119

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio, 44124

  • Driven Research

    Miami, Florida, 33126

  • Floridian Research Institute

    Miami, Florida, 33179

  • Southern IN Clinical Trials

    New Albany, Indiana, 47150

  • North Shore University Hospital

    New Hyde Park, New York, 11040

  • Cameron Dermatology

    New York, New York, 10023

  • Skin Specialists PC

    Omaha, Nebraska, 68144

  • Austin Inst for Clinical Research

    Pflugerville, Texas, 78660

  • MedDerm Associates

    San Diego, California, 92103

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239

  • Deluxe Dermatology

    St Louis, Missouri, 63117

  • University Of South Florida

    Tampa, Florida, 33612

  • Forefront Dermatology

    Vienna, Virginia, 22182

  • Center for Clinical Studies-Lee

    Webster, Texas, 77598

  • Dundee Dermatology

    West Dundee, Illinois, 60118

Other trials in United States

Germany13 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 13595

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Merzig, Saarland, 66663

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain10 sites

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Granollers, 08402

  • Novartis Investigative Site

    Las Palmas GC, 35010

  • Novartis Investigative Site

    Madrid, 28002

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Palma, Balearic Islands, 07120

  • Novartis Investigative Site

    Pontevedra, 36003

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)9 sites

  • Novartis Investigative Site

    Ankara, Bilkent Cankaya, 06800

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500

  • Novartis Investigative Site

    Aydin, Efeler, 09100

  • Novartis Investigative Site

    Denizli, Kinikli, 20070

  • Novartis Investigative Site

    Izmir, Balcova, 35340

  • Novartis Investigative Site

    Izmir, Buca, 35390

  • Novartis Investigative Site

    Izmir, 35100

  • Novartis Investigative Site

    Kecioren Ankara, 06010

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110

Other trials in Turkey (Türkiye)

France7 sites

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    Lyon, 69003

  • Novartis Investigative Site

    Nice, France, 06000

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Toulouse, 31400

Other trials in France

Hungary7 sites

  • Novartis Investigative Site

    Budapest, 1036

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Debrecen, Hajdú-Bihar, 4031

  • Novartis Investigative Site

    Kecskemét, 6001

  • Novartis Investigative Site

    Pécs, Baranya, 7623

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Czechia6 sites

  • Novartis Investigative Site

    Karlovy Vary, 360 01

  • Novartis Investigative Site

    Plzen Bolevec, 323 00

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague, 150 06

  • Novartis Investigative Site

    Prague, 180 81

Other trials in Czechia

Malaysia6 sites

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Johor Bahru, 80100

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88586

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Selangor Darul Ehsan, 68100

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502

Other trials in Malaysia

United Kingdom6 sites

  • Novartis Investigative Site

    Bristol, BS1 3NU

  • Novartis Investigative Site

    Cardiff, CF14 4XW

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS7 4SA

  • Novartis Investigative Site

    London, E1 2AT

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Canada5 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3

  • Novartis Investigative Site

    London, Ontario, N6H 5L5

  • Novartis Investigative Site

    Montreal, Quebec, H1Y 3L1

  • Novartis Investigative Site

    Québec, Quebec, G1V 4T3

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 1X9

Other trials in Canada

Colombia4 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Bogota, Cundinamarca, 111411

  • Novartis Investigative Site

    Medellín, Antioquia, 050010

  • Novartis Investigative Site

    Medellín, 050012

Other trials in Colombia

Romania4 sites

  • Novartis Investigative Site

    Bucharest, District 2, 020125

  • Novartis Investigative Site

    Bucharest, District 2, 020762

  • Novartis Investigative Site

    Bucharest, 010825

  • Novartis Investigative Site

    Timișoara, 300188

Other trials in Romania

Argentina3 sites

  • Novartis Investigative Site

    Caba, C1205AAO

  • Novartis Investigative Site

    CABA, C1012AAY

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000AAW

Other trials in Argentina

Belgium3 sites

  • Novartis Investigative Site

    Brussels, Brussels Capital, 1070

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

Greece3 sites

  • Novartis Investigative Site

    Athens, 161 21

  • Novartis Investigative Site

    Chaïdári, 124 62

  • Novartis Investigative Site

    Thessaloniki, 564 03

Other trials in Greece

Mexico3 sites

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80020

  • Novartis Investigative Site

    Durango, 34000

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Poland3 sites

  • Novartis Investigative Site

    Warsaw, Masovian Voivodeship, 02-953

  • Novartis Investigative Site

    Warsaw, 02-507

  • Novartis Investigative Site

    Warsaw, 02-962

Other trials in Poland

Austria1 site

  • Novartis Investigative Site

    Linz, 4020

Other trials in Austria

Puerto Rico1 site

  • Alma Cruz-Santana Private Practice

    Carolina, 00985

Other trials in Puerto Rico

About this study

Official title: 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).

Read the 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.

Being tested
Remibrutinib Dose A, Remibrutinib Dose B, Placebo 1, Placebo 2
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
Medical subject headings
Hidradenitis Suppurativa, Hidradenitis, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remibrutinib Dose ADrug

    Also called LOU064

    Remibrutinib Dose A (oral)

  • Remibrutinib Dose BDrug

    Also called LOU064

    Remibrutinib Dose B (oral)

  • Placebo 1Drug

    Placebo matching to remibrutinib Dose A (oral)

  • Placebo 2Drug

    Placebo matching to remibrutinib Dose B (oral)

Study groups in NCT06840392
Study groupRoleWhat they receive
Remibrutinib Dose A (Treatment Period 1 and 2)ExperimentalParticipants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2
Receives: Drug: Remibrutinib Dose A
Remibrutinib Dose B (Treatment Period 1 and 2)ExperimentalParticipants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2
Receives: Drug: Remibrutinib Dose B
Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2)Placebo comparatorParticipants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2
Receives: Drug: Remibrutinib Dose B; Drug: Placebo 1; Drug: Placebo 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 16

Secondary outcomes (8)

  1. 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

    Measured: Week 16

  2. 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).

    Measured: From baseline up to Week 16

  3. 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.

    Measured: Week 16

  4. 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.

    Measured: Up to Week 16

  5. 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.

    Measured: Week 8

  6. 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.

    Measured: Week 16

  7. 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.

    Measured: Week 16

  8. 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.

    Measured: From randomization to end of study, assessed up to 72 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start20 Mar 2025
  3. Primary completion3 Jun 2027 (estimated)
  4. Study completion21 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840392
Sponsor's protocol ID
CLOU064J12302
Other IDs
2024-513266-19-00
Acronym
RECHARGE-2
Status last verified
Oct 2026
First submitted
17 Feb 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remibrutinib Dose A and Remibrutinib Dose B in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 129 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Germany, Spain, Turkey (Türkiye), France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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