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Hidradenitis SuppurativaPhase 3NCT06799000

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

A Phase 3 study testing Remibrutinib Dose A and Remibrutinib Dose B in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 139 sites in 20 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
588 participants
Where
139 sitesin 20 countries
Study dates
31 Jan 2025to 4 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

139 sites in 20 countries.

139 sites in 20 countries

United States36 sites

  • Cheryl Effron MD Inc

    Anaheim, California, 92807

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • Equity Medical LLC

    Bowling Green, Kentucky, 42104

  • Medical University of South Carolina MUSC

    Charleston, South Carolina, 29425

  • Illinois Dermatology Institute

    Chicago, Illinois, 60602

  • Michigan Center for Rsrch Company

    Clarkston, Michigan, 48346

  • Florida Academic Centers Research and Education LLC

    Coral Gables, Florida, 33134

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • Revival Research Institute LLC

    Evans, Georgia, 30809

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • Care Access Hoboken

    Hoboken, New Jersey, 07030

  • OnSite Clinical Solutions LLC

    Huntersville, North Carolina, 28078

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana, 46256

  • University of Mississippi Med Ctr

    Jackson, Mississippi, 39216

  • Dermat. and Adv. Aesthetics

    Lake Charles, Louisiana, 70605

  • University of MiamiHealth System

    Miami, Florida, 33125

  • Advanced Research Experts

    Nashville, Tennessee, 37211

  • Forest Hills Dermatology Group

    New York, New York, 10003

  • Icahn School Of Med At Mount Sinai

    New York, New York, 10029

  • Virginia Clinical Research

    Norfolk, Virginia, 23507

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

  • UP Medical Center H System

    Pittsburgh, Pennsylvania, 15213-3403

  • Skinsearch of Rochester Inc

    Rochester, New York, 14623

  • Physioseq

    Sacramento, California, 95826

  • RFSA Dermatology

    San Antonio, Texas, 78213

  • Gwinnett Clinical Research Center

    Snellville, Georgia, 30078

  • Immunology-Rheumatology Research

    Suwanee, Georgia, 30024

  • Olive View UCLA Medical Center

    Sylmar, California, 91342

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320

  • Revival Research Institute

    Troy, Michigan, 48084

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

  • Howard University College of Medicine

    Washington D.C., District of Columbia, 20060

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104

Other trials in United States

Germany14 sites

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Darmstadt, Hesse, 64283

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hanover, 30159

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Langenau, Baden-Wurttemberg, 89129

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Münster, 48149

Other trials in Germany

China12 sites

  • Novartis Investigative Site

    Beijing, 100144

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Changsha, Hunan, 410008

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510000

  • Novartis Investigative Site

    Jinan, 250012

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016

  • Novartis Investigative Site

    Shenyang, Liaoning, 110011

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

  • Novartis Investigative Site

    Xian, Shanxi, 710004

Other trials in China

Italy10 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Catania, CT, 95123

  • Novartis Investigative Site

    Cona, FE, 44124

  • Novartis Investigative Site

    Florence, FI, 50122

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

Spain9 sites

  • Novartis Investigative Site

    Badalona, Barcelona, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Manises, Valencia, 46940

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Valencia, Valencia, 46017

  • Novartis Investigative Site

    Valencia, 46014

Other trials in Spain

Canada6 sites

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3

  • Novartis Investigative Site

    Québec, Quebec, G1W 4R4

  • Novartis Investigative Site

    Richmond Hill, Ontario, L4C 9M7

  • Novartis Investigative Site

    Saint-Jérôme, Quebec, J7Z 7E2

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Surrey, British Columbia, V3V 0C6

Other trials in Canada

Portugal6 sites

  • Novartis Investigative Site

    Almada, 2805-267

  • Novartis Investigative Site

    Braga, 4710-243

  • Novartis Investigative Site

    Coimbra, 3004-561

  • Novartis Investigative Site

    Lisbon, 1169-050

  • Novartis Investigative Site

    Lisbon, 1998-018

  • Novartis Investigative Site

    Porto, 4099-001

Other trials in Portugal

Australia5 sites

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

  • Novartis Investigative Site

    Parkville, Victoria, 3050

  • Novartis Investigative Site

    Phillip, Australian Capital Territory, 2606

  • Novartis Investigative Site

    Sydney, New South Wales, 2010

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

Other trials in Australia

Malaysia5 sites

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400

  • Novartis Investigative Site

    Kuching, Sarawak, 93586

  • Novartis Investigative Site

    Muar town, Johor, 84000

Other trials in Malaysia

Argentina4 sites

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEA

  • Novartis Investigative Site

    CABA, C1428DZF

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

Other trials in Argentina

Colombia4 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760032

  • Novartis Investigative Site

    Medellín, 050034

Other trials in Colombia

Mexico4 sites

  • Novartis Investigative Site

    Chihuahua City, 31203

  • Novartis Investigative Site

    Cuauhtémoc, Mexico City, 06100

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44340

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650

Other trials in Mexico

Slovakia4 sites

  • Novartis Investigative Site

    Bratislava, 811 09

  • Novartis Investigative Site

    Bratislava, 813 69

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

Other trials in Slovakia

South Africa4 sites

  • Novartis Investigative Site

    Cape Town, 7505

  • Novartis Investigative Site

    Durban, 4058

  • Novartis Investigative Site

    Raslouw Centurion, Gauteng, 0157

  • Novartis Investigative Site

    Soweto, Gauteng, 2013

Other trials in South Africa

Bulgaria3 sites

  • Novartis Investigative Site

    Sofia, Bulgaria, 1407

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Stara Zagora, Bulgaria, 6000

Other trials in Bulgaria

Greece3 sites

  • Novartis Investigative Site

    Chaïdári, 124 62

  • Novartis Investigative Site

    Heraklion Crete., 715 00

  • Novartis Investigative Site

    Thessaloniki, 546 43

Other trials in Greece

Poland3 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-094

  • Novartis Investigative Site

    Gdansk, 80-214

  • Novartis Investigative Site

    Lodz, 90-436

Other trials in Poland

Switzerland3 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Taiwan3 sites

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Denmark1 site

  • Novartis Investigative Site

    Roskilde, 4000

Other trials in Denmark

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-1)

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 NCT06799000
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 posted29 Jan 2025
  2. Study start31 Jan 2025
  3. Primary completion17 May 2027 (estimated)
  4. Study completion4 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
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799000
Sponsor's protocol ID
CLOU064J12301
Other IDs
2024-513282-39-00
Status last verified
Oct 2026
First submitted
23 Jan 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 139 sites in 20 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 139 sites in United States, Germany, China, Italy, Spain and 15 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 NCT06799000.

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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Clinical Trial NCT06799000 | AzTrials