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

NCT07855276 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: CLOU064J121012025-524222-18-002025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Keywords

BTK inhibitor; hidradenitis suppurativa; sHiSCR; remibrutinib

Outcome Measures

Primary Outcomes (1)

• Fold change from baseline in auto-antibodies

  To evaluate the effect of remibrutinib compared with placebo.

  Baseline, Week 16

Secondary Outcomes (1)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 20

Study Arms (2)

LOU064

EXPERIMENTAL

Participants will receive remibrutinib during treatment period.

Drug: LOU064

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo during treatment period.

Drug: Placebo

Interventions

LOU064 DRUG

Remibrutinib

Also known as: remibrutinib

LOU064

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): June 19, 2028
• Study Completion (Estimated): July 17, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share