An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

September 11, 2026 updated by: Novartis Pharmaceuticals

A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a global Phase 3, multicentre, double-blind, double-dummy, parallel-group extension study. It fulfils the Novartis commitment to provide post-trial access.

The study includes a double-blind and an open-label treatment phase:

Double-blind, double-dummy treatment continues from Week 68 (end of core study) until final database lock (DBL) of both core studies or until up titration. Participants remain on the same blinded regimen they were on during Treatment Period 2 of the preceding Phase 3 studies.

After final DBL of both core studies, treatment transitions to open-label.

Participants will continue treatment until commercial availability and reimbursement in their country, another access mechanism is available, or 4 years of extension treatment is completed.

Participants who discontinue treatment early or do not transition to commercial remibrutinib will enter a 4-week treatment-free safety follow-up.

Study Type

Interventional

Enrollment (Estimated)

710

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • CABA, Argentina, C1428DZF
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1425BEA
        • Recruiting
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Recruiting
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DBS
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Recruiting
        • Johnson Dermatology
        • Principal Investigator:
          • Sandra Johnson
        • Contact:
    • California
      • Fremont, California, United States, 95438
        • Recruiting
        • Ctr for Dermatology Clinical Res
        • Principal Investigator:
          • Sunil Dhawan
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Keck School of Medicine
        • Principal Investigator:
          • Katrina Lee
        • Contact:
      • Sylmar, California, United States, 91342
        • Recruiting
        • Olive View UCLA Medical Center
        • Principal Investigator:
          • April Armstrong
        • Contact:
      • Thousand Oaks, California, United States, 91320
        • Recruiting
        • Clinical Trials Research Institute
        • Principal Investigator:
          • Navid Ezra
        • Contact:
    • Illinois
      • Glenview, Illinois, United States, 60077
      • West Dundee, Illinois, United States, 60118
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Southern IN Clinical Trials
        • Contact:
        • Principal Investigator:
          • Megan Landis
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists PC
        • Principal Investigator:
          • Joel Schlessinger
        • Contact:
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Cameron Dermatology
        • Principal Investigator:
          • Michael Cameron
        • Contact:
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Optima Research Boardman
        • Principal Investigator:
          • Patrick Shannon
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Apex Clinical Research Center LLC
        • Principal Investigator:
          • Jorge Garcia-Zuazaga
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Clinical Research Ctr of Carolinas
        • Principal Investigator:
          • Todd Schlesinger
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Signed informed consent must be obtained before any assessment is performed.
  • Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
  • Participant does not meet any treatment discontinuation criteria of the core study at Week 68.

Key Exclusion Criteria:

  • Ongoing or planned use of prohibited HS or non-HS treatments.
  • Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
  • Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remibrutinib Dose A
Participants randomized during the core study to receive remibrutinib Dose A
Drug: Remibrutinib
Remibrutinib Dose A and B (oral)
Other Names:
  • LOU064
Experimental: Remibrutinib Dose B
Participants randomized during the core study to receive remibrutinib Dose B
Drug: Remibrutinib
Remibrutinib Dose A and B (oral)
Other Names:
  • LOU064

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline, up to Week 280
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.
Baseline, up to Week 280

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with AN50/75/90 response
Time Frame: Baseline, up to Week 276
Achievement of AN50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline.
Baseline, up to Week 276
Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4)
Time Frame: Baseline, up to Week 276
The IHS4 is a disease severity score calculated as a weighted sum of inflammatory lesion counts: nodules (×1), abscesses (×2), and draining tunnels (×4). Scores are categorised as mild (≤3), moderate (4-10), and severe (≥11). Higher scores indicate greater disease severity (worse outcome).
Baseline, up to Week 276
Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response
Time Frame: Baseline, up to Week 276
Achievement of HiSCR50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in AN count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Baseline, up to Week 276
Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst
Time Frame: Baseline, up to Week 276
Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the core 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.
Baseline, up to Week 276

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2026

Primary Completion (Estimated)

October 24, 2031

Study Completion (Estimated)

October 24, 2031

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOU064J12303B
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523259-72-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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