A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with different types of lesions.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Key Inclusion Criteria:

• Male and female participants ≥ 18 years to 65 years of age at the time of signing of the informed consent forms (ICF).
• Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to Day 1.
• Participants with moderate to severe HS at Day 1 defined as:
• A total of at least 5 abscesses and inflammatory nodules (AN), i.e. abscesses and/or inflammatory nodules
• Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae).
• At least 1 chronic lesion, which is defined by the presence of a draining tunnel and further meeting biopsy criteria as defined in the laboratory manual.

Key Exclusion Criteria:

• Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
• Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
• Previous exposure to remibrutinib or other BTK inhibitors.
• Previous exposure to investigational Janus Kinase (JAK) inhibitors.
• Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical 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.
• Significant bleeding risk or coagulation disorders.
• History or current hepatic disease (moderate to severe Hepatic Impairment (HI) as per Child-Pugh classification), including but not limited to, acute or chronic hepatitis (with the exception of Hepatitis B or C - see respective exclusion criterion above), cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at Screening.
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). WOCBP are excluded unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 7 days after stopping study treatment. Highly effective contraception methods.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Novartis Pharmaceuticals

Study start

Oct 29, 2026 Actual

Primary completion

Nov 29, 2027 Estimated

Study completion

Dec 27, 2027 Estimated

First posted

Oct 2, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts