Recruiting
Phase 3

Remibrutinib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07665437

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Study Details

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.

Conditions

Hidradenitis Suppurativa

Study ID

NCT07665437

Start date

Jul 10, 2026

Status verified date

Sep, 2026

Completion date

Oct 24, 2031

Anticipated

Primary completion date

Oct 24, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

710 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remibrutinib Dose A

Participants randomized during the core study to receive remibrutinib Dose A

experimental: Remibrutinib Dose B

Participants randomized during the core study to receive remibrutinib Dose B

Interventions

Remibrutinib

Remibrutinib Dose A and B (oral)

Primary outcome measure

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, up to Week 280 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111

Locations

Johnson Dermatology

Recruiting

Fort Smith, Arkansas, United States, 72916

Contacts

Christa Elliott

+1 479 649 3376celliott@johnsondermatology.com

Principal Investigator:

Sandra Johnson

Ctr for Dermatology Clinical Res

Recruiting

Fremont, California, United States, 95438

Contacts

Evguenia Vals

+1 510 797 0140evgueniav@ctr4derm.com

Principal Investigator:

Sunil Dhawan

USC Keck School of Medicine

Recruiting

Los Angeles, California, United States, 90033

Contacts

Rudy Rocha

rudy.rocha@med.usc.edu

Principal Investigator:

Katrina Lee

Olive View UCLA Medical Center

Recruiting

Sylmar, California, United States, 91342

Contacts

Noel Yang

+1 424 365 4129NXYang@mednet.ucla.edu

Principal Investigator:

April Armstrong

Clinical Trials Research Institute

Recruiting

Thousand Oaks, California, United States, 91320

Contacts

Luke Park

lpark@northridgetrials.com

Principal Investigator:

Navid Ezra

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60077

Contacts

Megan Calderon

megan.calderon@endeavorhealth.org

Principal Investigator:

Shannon Ewing

Dundee Dermatology

Recruiting

West Dundee, Illinois, United States, 60118

Contacts

JoAnn Hawkinson

joannchawkinson@gmail.com

Principal Investigator:

Paul Getz

Southern IN Clinical Trials

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Misty Humphress

mhumphress@soinct.com

Principal Investigator:

Megan Landis

Skin Specialists PC

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Kayleigh Koziol

+1 402 334 7546kayleigh@lovelyskin.com

Principal Investigator:

Joel Schlessinger

Cameron Dermatology

Recruiting

New York, New York, United States, 10023

Contacts

Yamiles Gonzalez

ygonzalez@equity-med.com

Principal Investigator:

Michael Cameron

Optima Research Boardman

Recruiting

Boardman, Ohio, United States, 44512

Contacts

Sarah Merlo

+1 330 271 8614smerlo@optimatrials.com

Principal Investigator:

Patrick Shannon

Apex Clinical Research Center LLC

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Stacey Spigiel

sspigiel@apexskin.com

Principal Investigator:

Jorge Garcia-Zuazaga

Clinical Research Ctr of Carolinas

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Gina Gregory

+1 843 556 8886gina.gregory@dermandlaser.com

Principal Investigator:

Todd Schlesinger

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6H 5L5

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • BTK inhibitor
  • hidradenitis suppurativa
  • HiSCR
  • remibrutinib
  • Phase 3
  • extension study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-04.