Hidradenitis SuppurativaPhase 3NCT07665437
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
A Phase 3 study testing Remibrutinib in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 44 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Remibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 10 Jul 2026to 29 Oct 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
44 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
44 sites in 9 countries
United States21 sites, 21 recruiting
- Recruiting
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205
Brittany Powell, Brittanyp@totalskinandbeauty.com
Rajini Murthy
- Recruiting
Optima Research Boardman
Boardman, Ohio, 44512
Sarah Merlo, +1 330 271 8614, smerlo@optimatrials.com
Patrick Shannon
- Recruiting
Clinical Research Ctr of Carolinas
Charleston, South Carolina, 29407
Gina Gregory, +1 843 556 8886, gina.gregory@dermandlaser.com
Todd Schlesinger
- Recruiting
Johnson Dermatology
Fort Smith, Arkansas, 72916
Christa Elliott, +1 479 649 3376, celliott@johnsondermatology.com
Sandra Johnson
- Recruiting
Ctr for Dermatology Clinical Res
Fremont, California, 95438
Evguenia Vals, +1 510 797 0140, evgueniav@ctr4derm.com
Sunil Dhawan
- Recruiting
Endeavor Health
Glenview, Illinois, 60077
Megan Calderon, megan.calderon@endeavorhealth.org
Shannon Ewing
- Recruiting
OnSite Clinical Solutions LLC
Huntersville, North Carolina, 28078
April Page, +1 800 785 3150, apage@onsiteclinical.com
Nicole Seminara-Zambrzycka
- Recruiting
USC Keck School of Medicine
Los Angeles, California, 90033
Rudy Rocha, rudy.rocha@med.usc.edu
Katrina Lee
- Recruiting
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Stacey Spigiel, sspigiel@apexskin.com
Jorge Garcia-Zuazaga
- Recruiting
Floridian Research Institute
Miami, Florida, 33179
Luis Javier Arechavaleta, jarechavaleta@floridianresearch.com
Faride Ramos
- Recruiting
Southern IN Clinical Trials
New Albany, Indiana, 47150
Misty Humphress, mhumphress@soinct.com
Megan Landis
- Recruiting
Cameron Dermatology
New York, New York, 10023
Yamiles Gonzalez, ygonzalez@equity-med.com
Michael Cameron
- Recruiting
Icahn School Of Med At Mount Sinai
New York, New York, 10029
Jillian Gray, jillian.gray@mssm.edu
Nadine Kaskas
- Recruiting
Arkansas Research Trials
North Little Rock, Arkansas, 72117
Shawna Owens, +1 501 621 1100, sowens@arkansasresearchtrials.com
Scott Michael Dinehart
- Recruiting
Skin Specialists PC
Omaha, Nebraska, 68144
Kayleigh Koziol, +1 402 334 7546, kayleigh@lovelyskin.com
Joel Schlessinger
- Recruiting
UP Medical Center H System
Pittsburgh, Pennsylvania, 15213-3403
Neethi Francis, +1 412 647 2013, francisn2@upmc.edu
Joe Kuanheng Tung
- Recruiting
Olive View UCLA Medical Center
Sylmar, California, 91342
Noel Yang, +1 424 365 4129, NXYang@mednet.ucla.edu
April Armstrong
- Recruiting
University Of South Florida
Tampa, Florida, 33612
Zachary Leniek, +1 813 974 6378, leniekz@usf.edu
Ann Lin
- Recruiting
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Joanna Vargas, jvargas@eliteclinicalnetwork.com
Navid Ezra
- Recruiting
Center for Clinical Studies-Lee
Webster, Texas, 77598
Karina Gonzalez, +1 281 333 2288, kgonzalez@ccstexas.com
Patricia C Lee
- Recruiting
Dundee Dermatology
West Dundee, Illinois, 60118
JoAnn Hawkinson, joannchawkinson@gmail.com
Paul Getz
Argentina5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Caba, Buenos Aires, C1119ACN
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1425BEA
- Recruiting
Novartis Investigative Site
CABA, C1012AAY
- Recruiting
Novartis Investigative Site
CABA, C1428DZF
- Recruiting
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
Malaysia5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
George Town, Pulau Pinang, 10450
- Recruiting
Novartis Investigative Site
Ipoh, Perak, 30450
- Recruiting
Novartis Investigative Site
Kota Kinabalu, Sabah, 88586
- Recruiting
Novartis Investigative Site
Muar town, Johor, 84000
- Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, 68100
Canada4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Edmonton, Alberta, T6G 1C3
- Recruiting
Novartis Investigative Site
London, Ontario, N6H 5L5
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H1Y 3L1
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1V 4T3
Australia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Melbourne, Victoria, 3004
- Recruiting
Novartis Investigative Site
Parkville, Victoria, 3050
- Recruiting
Novartis Investigative Site
Sydney, New South Wales, 2010
Spain3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, Catalonia, 08003
- Recruiting
Novartis Investigative Site
Las Palmas GC, 35010
- Recruiting
Novartis Investigative Site
Madrid, 28041
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Bochum, 44791
About this study
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
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Remibrutinib
- Keywords
- BTK inhibitor, hidradenitis suppurativa, HiSCR, remibrutinib, Phase 3, extension study
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
Remibrutinib Dose A and B (oral)
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib Dose A | Experimental | Participants randomized during the core study to receive remibrutinib Dose A Receives: Drug: Remibrutinib |
| Remibrutinib Dose B | Experimental | Participants randomized during the core study to receive remibrutinib Dose B Receives: Drug: Remibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to Week 280
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, up to Week 276
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jul 2026
- Primary completion29 Oct 2031 (estimated)
- Study completion29 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665437
- Sponsor's protocol ID
- CLOU064J12303B
- Other IDs
- 2025-523259-72-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.