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Assessing the effects of remibrutinib on moderate to severe hidradenitis suppurativa

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)

Phase 3 Interventional Novartis · NCT06840392

This study is testing if a new medication called remibrutinib can help adults with moderate to severe hidradenitis suppurativa feel better over a 76-week period.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment555 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsremibrutinib
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT06840392 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of remibrutinib, a Bruton's tyrosine kinase inhibitor, in adults with moderate to severe hidradenitis suppurativa (HS). The study spans 76 weeks, including a 16-week double-blind treatment phase with either remibrutinib or placebo, followed by a 52-week treatment phase with remibrutinib. Participants who discontinue treatment are encouraged to remain in the study for safety follow-up. The trial aims to provide insights into the clinical response of HS to this new treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of moderate to severe hidradenitis suppurativa lasting at least 6 months.

Not a fit: Patients with more than 20 fistulae or those with active skin diseases that could interfere with HS assessment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe hidradenitis suppurativa, offering relief to patients suffering from this chronic condition.

How similar studies have performed: Other studies involving BTK inhibitors have shown promise in treating various inflammatory conditions, suggesting potential success for this approach in hidradenitis suppurativa.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaBruton's tyrosine kinase inhibitorHSHidradenitis Suppurativa clinical responseHiSCRremibrutinibLOU064Hidradenitides, Suppurativa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.