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

A Randomized, Double-blind, Placebo-controlled Mechanistic Study in Adult Patients With Moderate to Severe Hidradenitis Suppurativa to Explore the Effects of Remibrutinib on Tissue Level

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Placebo; Drug: LOU064

Detailed Description

This is a Phase 1, interventional, multicenter, randomized, double-blind, parallel group, placebo-controlled, exploratory study to evaluate the MoA of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa.

The total duration of the study is 24 weeks and consists of Screening (up to 4 weeks), Treatment (16 weeks, double-blind treatment with remibrutinib or placebo), and Follow-up (treatment-free follow-up for 4 weeks) periods.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• United States
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Apex Clinical Research Center LLC
      • Principal Investigator: Jorge Garcia-Zuazaga
      • Contact: Caroline Matyas; Email: cmatyas@apexskin.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOU064; Participants will receive remibrutinib during treatment period.	Drug: LOU064; Remibrutinib; Other Names: remibrutinib
Placebo Comparator: Placebo; Participants will receive matching placebo during treatment period.	Drug: Placebo; matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fold change from baseline in auto-antibodies	To evaluate the effect of remibrutinib compared with placebo.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.	Up to Week 20

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): January 18, 2028

Study Registration Dates

• First Submitted: September 28, 2026
• First Submitted That Met QC Criteria: September 28, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 16, 2026
• Last Update Submitted That Met QC Criteria: October 12, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: BTK inhibitor; hidradenitis suppurativa; remibrutinib; sHiSCR
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; remibrutinib
• Other Study ID Numbers: CLOU064J12101; 2025 (U.S. NIH Grant/Contract); 2025-524222-18-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No