NCT07665437

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
710

participants targeted

Target at P75+ for phase_3

Timeline
64mo left

Started Jul 2026

Longer than P75 for phase_3

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Oct 2031

First Submitted

Initial submission to the registry

June 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2031

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

5.3 years

First QC Date

June 18, 2026

Last Update Submit

July 14, 2026

Conditions

Hidradenitis Suppurativa

Keywords

BTK inhibitorhidradenitis suppurativaHiSCRremibrutinibPhase 3extension study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of participants with AN50/75/90 response

    Baseline, up to Week 276

  • Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4)

    Baseline, up to Week 276

  • Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response

    Baseline, up to Week 276

  • Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst

    Baseline, up to Week 276

Study Arms (2)

Remibrutinib Dose A

EXPERIMENTAL

Participants randomized during the core study to receive remibrutinib Dose A

Drug: Remibrutinib

Remibrutinib Dose B

EXPERIMENTAL

Participants randomized during the core study to receive remibrutinib Dose B

Drug: Remibrutinib

Interventions

RemibrutinibDRUG

Remibrutinib Dose A and B (oral)

Also known as: LOU064
Remibrutinib Dose ARemibrutinib Dose B

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Caba, Buenos Aires, C1119ACN, Argentina

RECRUITING

Novartis Investigative Site

CABA, C1428DZF, Argentina

RECRUITING

Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

RECRUITING

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 24, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

October 27, 2031

Study Completion (Estimated)

October 27, 2031

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Locations

AR(2)AU(2)