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RecruitingPhase 3

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

Novartis Pharmaceuticals · NCT07665437

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
710
US sites recruiting
21
Study start
July 10, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Remibrutinib

Conditions: Hidradenitis Suppurativa

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, AL 35205

    Site contact: Brittany Powell · Brittanyp@totalskinandbeauty.com

  • Johnson Dermatology

    Fort Smith, AR 72916

    Site contact: Christa Elliott · +1 479 649 3376 · celliott@johnsondermatology.com

  • Arkansas Research Trials

    North Little Rock, AR 72117

    Site contact: Shawna Owens · +1 501 621 1100 · sowens@arkansasresearchtrials.com

  • Ctr for Dermatology Clinical Res

    Fremont, CA 95438

    Site contact: Evguenia Vals · +1 510 797 0140 · evgueniav@ctr4derm.com

  • USC Keck School of Medicine

    Los Angeles, CA 90033

    Site contact: Rudy Rocha · rudy.rocha@med.usc.edu

  • Olive View UCLA Medical Center

    Sylmar, CA 91342

    Site contact: Noel Yang · +1 424 365 4129 · NXYang@mednet.ucla.edu

  • Clinical Trials Research Institute

    Thousand Oaks, CA 91320

    Site contact: Joanna Vargas · jvargas@eliteclinicalnetwork.com

  • Floridian Research Institute

    Miami, FL 33179

    Site contact: Luis Javier Arechavaleta · jarechavaleta@floridianresearch.com

  • University Of South Florida

    Tampa, FL 33612

    Site contact: Zachary Leniek · +1 813 974 6378 · leniekz@usf.edu

  • Endeavor Health

    Glenview, IL 60077

    Site contact: Megan Calderon · megan.calderon@endeavorhealth.org

  • Dundee Dermatology

    West Dundee, IL 60118

    Site contact: JoAnn Hawkinson · joannchawkinson@gmail.com

  • Southern IN Clinical Trials

    New Albany, IN 47150

    Site contact: Misty Humphress · mhumphress@soinct.com

  • Skin Specialists PC

    Omaha, NE 68144

    Site contact: Kayleigh Koziol · +1 402 334 7546 · kayleigh@lovelyskin.com

  • Cameron Dermatology

    New York, NY 10023

    Site contact: Yamiles Gonzalez · ygonzalez@equity-med.com

  • Icahn School Of Med At Mount Sinai

    New York, NY 10029

    Site contact: Jillian Gray · jillian.gray@mssm.edu

  • OnSite Clinical Solutions LLC

    Huntersville, NC 28078

    Site contact: April Page · +1 800 785 3150 · apage@onsiteclinical.com

  • Optima Research Boardman

    Boardman, OH 44512

    Site contact: Sarah Merlo · +1 330 271 8614 · smerlo@optimatrials.com

  • Apex Clinical Research Center LLC

    Mayfield Heights, OH 44124

    Site contact: Stacey Spigiel · sspigiel@apexskin.com

  • UP Medical Center H System

    Pittsburgh, PA 15213-3403

    Site contact: Neethi Francis · +1 412 647 2013 · francisn2@upmc.edu

  • Clinical Research Ctr of Carolinas

    Charleston, SC 29407

    Site contact: Gina Gregory · +1 843 556 8886 · gina.gregory@dermandlaser.com

  • Center for Clinical Studies-Lee

    Webster, TX 77598

    Site contact: Karina Gonzalez · +1 281 333 2288 · kgonzalez@ccstexas.com

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
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An Extension Study to Assess Safety and Efficacy of Remibrutinib… (NCT07665437) | Bored Studies