What this study is
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.
What's being tested
- Remibrutinib
Intervention · DRUG
Remibrutinib Dose A and B (oral)
Study details
- Official title
- 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
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- Hidradenitis Suppurativa
- Enrolling
- 710 people
- Starts
- 2026-07-10
- Est. completion
- 2031-10-29
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (44)
44 openTotal Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
- Brittany Powell · ContactBrittanyp@totalskinandbeauty.com
- Rajini Murthy · Principal investigator
RecruitingJohnson Dermatology
Fort Smith, Arkansas, United States
- Christa Elliott · Contact+1 479 649 3376celliott@johnsondermatology.com
- Sandra Johnson · Principal investigator
RecruitingArkansas Research Trials
North Little Rock, Arkansas, United States
- Shawna Owens · Contact+1 501 621 1100sowens@arkansasresearchtrials.com
- Scott Michael Dinehart · Principal investigator
RecruitingCtr for Dermatology Clinical Res
Fremont, California, United States
- Evguenia Vals · Contact+1 510 797 0140evgueniav@ctr4derm.com
- Sunil Dhawan · Principal investigator
RecruitingUSC Keck School of Medicine
Los Angeles, California, United States
- Rudy Rocha · Contactrudy.rocha@med.usc.edu
- Katrina Lee · Principal investigator
RecruitingOlive View UCLA Medical Center
Sylmar, California, United States
- Noel Yang · Contact+1 424 365 4129NXYang@mednet.ucla.edu
- April Armstrong · Principal investigator
RecruitingClinical Trials Research Institute
Thousand Oaks, California, United States
- Joanna Vargas · Contactjvargas@eliteclinicalnetwork.com
- Navid Ezra · Principal investigator
RecruitingFloridian Research Institute
Miami, Florida, United States
- Luis Javier Arechavaleta · Contactjarechavaleta@floridianresearch.com
- Faride Ramos · Principal investigator
RecruitingUniversity Of South Florida
Tampa, Florida, United States
- Zachary Leniek · Contact+1 813 974 6378leniekz@usf.edu
- Ann Lin · Principal investigator
RecruitingEndeavor Health
Glenview, Illinois, United States
- Megan Calderon · Contactmegan.calderon@endeavorhealth.org
- Shannon Ewing · Principal investigator
RecruitingDundee Dermatology
West Dundee, Illinois, United States
- JoAnn Hawkinson · Contactjoannchawkinson@gmail.com
- Paul Getz · Principal investigator
RecruitingSouthern IN Clinical Trials
New Albany, Indiana, United States
- Misty Humphress · Contactmhumphress@soinct.com
- Megan Landis · Principal investigator
RecruitingSkin Specialists PC
Omaha, Nebraska, United States
- Kayleigh Koziol · Contact+1 402 334 7546kayleigh@lovelyskin.com
- Joel Schlessinger · Principal investigator
RecruitingCameron Dermatology
New York, New York, United States
- Yamiles Gonzalez · Contactygonzalez@equity-med.com
- Michael Cameron · Principal investigator
RecruitingIcahn School Of Med At Mount Sinai
New York, New York, United States
- Jillian Gray · Contactjillian.gray@mssm.edu
- Nadine Kaskas · Principal investigator
RecruitingOnSite Clinical Solutions LLC
Huntersville, North Carolina, United States
- April Page · Contact+1 800 785 3150apage@onsiteclinical.com
- Nicole Seminara-Zambrzycka · Principal investigator
RecruitingOptima Research Boardman
Boardman, Ohio, United States
- Sarah Merlo · Contact+1 330 271 8614smerlo@optimatrials.com
- Patrick Shannon · Principal investigator
RecruitingApex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
- Stacey Spigiel · Contactsspigiel@apexskin.com
- Jorge Garcia-Zuazaga · Principal investigator
RecruitingUP Medical Center H System
Pittsburgh, Pennsylvania, United States
- Neethi Francis · Contact+1 412 647 2013francisn2@upmc.edu
- Joe Kuanheng Tung · Principal investigator
RecruitingClinical Research Ctr of Carolinas
Charleston, South Carolina, United States
- Gina Gregory · Contact+1 843 556 8886gina.gregory@dermandlaser.com
- Todd Schlesinger · Principal investigator
RecruitingCenter for Clinical Studies-Lee
Webster, Texas, United States
- Karina Gonzalez · Contact+1 281 333 2288kgonzalez@ccstexas.com
- Patricia C Lee · Principal investigator
Recruiting
23 sites outside the US
Novartis Investigative Site
Caba, Buenos Aires, Argentina
RecruitingNovartis Investigative Site
CABA, Buenos Aires, Argentina
RecruitingNovartis Investigative Site
Rosario, Santa Fe Province, Argentina
RecruitingNovartis Investigative Site
CABA, Argentina
RecruitingNovartis Investigative Site
CABA, Argentina
RecruitingNovartis Investigative Site
Sydney, New South Wales, Australia
RecruitingNovartis Investigative Site
Melbourne, Victoria, Australia
RecruitingNovartis Investigative Site
Parkville, Victoria, Australia
RecruitingNovartis Investigative Site
Edmonton, Alberta, Canada
RecruitingNovartis Investigative Site
London, Ontario, Canada
RecruitingNovartis Investigative Site
Montreal, Quebec, Canada
RecruitingNovartis Investigative Site
Québec, Quebec, Canada
RecruitingNovartis Investigative Site
Beijing, China
RecruitingNovartis Investigative Site
Lyon, France
RecruitingNovartis Investigative Site
Bochum, Germany
RecruitingNovartis Investigative Site
Muar town, Johor, Malaysia
RecruitingNovartis Investigative Site
Ipoh, Perak, Malaysia
RecruitingNovartis Investigative Site
George Town, Pulau Pinang, Malaysia
RecruitingNovartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
RecruitingNovartis Investigative Site
Selangor Darul Ehsan, Malaysia
RecruitingNovartis Investigative Site
Barcelona, Catalonia, Spain
RecruitingNovartis Investigative Site
Las Palmas GC, Spain
RecruitingNovartis Investigative Site
Madrid, Spain
Recruiting
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CLOU064J12303B
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.