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

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: Not yet recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Remibrutinib

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

• 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

Participation Criteria

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

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: 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)	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	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)	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	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	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

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): October 27, 2031
• Study Completion (Estimated): October 27, 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): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Phase 3; BTK inhibitor; hidradenitis suppurativa; remibrutinib; HiSCR; extension study
• 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: CLOU064J12303B

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