An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-post: novartis.email@novartis.com
Studer Kontakt Backup
- Navn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
Studiesteder
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CABA, Argentina, C1012AAY
- Rekruttering
- Novartis Investigative Site
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CABA, Argentina, C1428DZF
- Rekruttering
- Novartis Investigative Site
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1425BEA
- Rekruttering
- Novartis Investigative Site
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Caba, Buenos Aires, Argentina, C1119ACN
- Rekruttering
- Novartis Investigative Site
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DBS
- Rekruttering
- Novartis Investigative Site
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New South Wales
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Sydney, New South Wales, Australia, 2010
- Rekruttering
- Novartis Investigative Site
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Victoria
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Melbourne, Victoria, Australia, 3004
- Rekruttering
- Novartis Investigative Site
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Parkville, Victoria, Australia, 3050
- Rekruttering
- Novartis Investigative Site
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Alberta
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Edmonton, Alberta, Canada, T6G 1C3
- Rekruttering
- Novartis Investigative Site
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Ontario
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London, Ontario, Canada, N6H 5L5
- Rekruttering
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canada, H1Y 3L1
- Rekruttering
- Novartis Investigative Site
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Québec, Quebec, Canada, G1V 4T3
- Rekruttering
- Novartis Investigative Site
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Alabama
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Birmingham, Alabama, Forente stater, 35205
- Rekruttering
- Total Skin and Beauty Dermatology Center PC
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Hovedetterforsker:
- Rajini Murthy
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Ta kontakt med:
- Brittany Powell
- E-post: Brittanyp@totalskinandbeauty.com
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Arkansas
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Fort Smith, Arkansas, Forente stater, 72916
- Rekruttering
- Johnson Dermatology
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Hovedetterforsker:
- Sandra Johnson
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Ta kontakt med:
- Christa Elliott
- Telefonnummer: +1 479 649 3376
- E-post: celliott@johnsondermatology.com
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North Little Rock, Arkansas, Forente stater, 72117
- Rekruttering
- Arkansas Research Trials
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Hovedetterforsker:
- Scott Michael Dinehart
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Ta kontakt med:
- Shawna Owens
- Telefonnummer: +1 501 621 1100
- E-post: sowens@arkansasresearchtrials.com
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California
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Fremont, California, Forente stater, 95438
- Rekruttering
- Ctr for Dermatology Clinical Res
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Hovedetterforsker:
- Sunil Dhawan
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Ta kontakt med:
- Evguenia Vals
- Telefonnummer: +1 510 797 0140
- E-post: evgueniav@ctr4derm.com
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Los Angeles, California, Forente stater, 90033
- Rekruttering
- USC Keck School of Medicine
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Hovedetterforsker:
- Katrina Lee
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Ta kontakt med:
- Rudy Rocha
- E-post: rudy.rocha@med.usc.edu
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Sylmar, California, Forente stater, 91342
- Rekruttering
- Olive View UCLA Medical Center
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Hovedetterforsker:
- April Armstrong
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Ta kontakt med:
- Noel Yang
- Telefonnummer: +1 424 365 4129
- E-post: NXYang@mednet.ucla.edu
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Thousand Oaks, California, Forente stater, 91320
- Rekruttering
- Clinical Trials Research Institute
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Hovedetterforsker:
- Navid Ezra
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Ta kontakt med:
- Joanna Vargas
- E-post: jvargas@eliteclinicalnetwork.com
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Florida
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Miami, Florida, Forente stater, 33179
- Rekruttering
- Floridian Research Institute
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Ta kontakt med:
- Luis Javier Arechavaleta
- E-post: jarechavaleta@floridianresearch.com
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Hovedetterforsker:
- Faride Ramos
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- University Of South Florida
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Hovedetterforsker:
- Ann Lin
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Ta kontakt med:
- Zachary Leniek
- Telefonnummer: +1 813 974 6378
- E-post: leniekz@usf.edu
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Illinois
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Glenview, Illinois, Forente stater, 60077
- Rekruttering
- Endeavor Health
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Hovedetterforsker:
- Shannon Ewing
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Ta kontakt med:
- Megan Calderon
- E-post: megan.calderon@endeavorhealth.org
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West Dundee, Illinois, Forente stater, 60118
- Rekruttering
- Dundee Dermatology
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Hovedetterforsker:
- Paul Getz
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Ta kontakt med:
- JoAnn Hawkinson
- E-post: joannchawkinson@gmail.com
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Indiana
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New Albany, Indiana, Forente stater, 47150
- Rekruttering
- Southern IN Clinical Trials
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Ta kontakt med:
- Misty Humphress
- E-post: mhumphress@soinct.com
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Hovedetterforsker:
- Megan Landis
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Nebraska
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Omaha, Nebraska, Forente stater, 68144
- Rekruttering
- Skin Specialists PC
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Hovedetterforsker:
- Joel Schlessinger
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Ta kontakt med:
- Kayleigh Koziol
- Telefonnummer: +1 402 334 7546
- E-post: kayleigh@lovelyskin.com
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New York
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New York, New York, Forente stater, 10023
- Rekruttering
- Cameron Dermatology
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Hovedetterforsker:
- Michael Cameron
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Ta kontakt med:
- Yamiles Gonzalez
- E-post: ygonzalez@equity-med.com
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School Of Med At Mount Sinai
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Ta kontakt med:
- Jillian Gray
- E-post: jillian.gray@mssm.edu
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Hovedetterforsker:
- Nadine Kaskas
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North Carolina
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Huntersville, North Carolina, Forente stater, 28078
- Rekruttering
- OnSite Clinical Solutions LLC
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Hovedetterforsker:
- Nicole Seminara-Zambrzycka
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Ta kontakt med:
- April Page
- Telefonnummer: +1 800 785 3150
- E-post: apage@onsiteclinical.com
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Ohio
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Boardman, Ohio, Forente stater, 44512
- Rekruttering
- Optima Research Boardman
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Hovedetterforsker:
- Patrick Shannon
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Ta kontakt med:
- Sarah Merlo
- Telefonnummer: +1 330 271 8614
- E-post: smerlo@optimatrials.com
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Mayfield Heights, Ohio, Forente stater, 44124
- Rekruttering
- Apex Clinical Research Center LLC
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Hovedetterforsker:
- Jorge Garcia-Zuazaga
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Ta kontakt med:
- Stacey Spigiel
- E-post: sspigiel@apexskin.com
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213-3403
- Rekruttering
- UP Medical Center H System
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Hovedetterforsker:
- Joe Kuanheng Tung
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Ta kontakt med:
- Neethi Francis
- Telefonnummer: +1 412 647 2013
- E-post: francisn2@upmc.edu
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South Carolina
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Charleston, South Carolina, Forente stater, 29407
- Rekruttering
- Clinical Research Ctr of Carolinas
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Hovedetterforsker:
- Todd Schlesinger
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Ta kontakt med:
- Gina Gregory
- Telefonnummer: +1 843 556 8886
- E-post: gina.gregory@dermandlaser.com
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Texas
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Webster, Texas, Forente stater, 77598
- Rekruttering
- Center for Clinical Studies-Lee
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Hovedetterforsker:
- Patricia C Lee
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Ta kontakt med:
- Karina Gonzalez
- Telefonnummer: +1 281 333 2288
- E-post: kgonzalez@ccstexas.com
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Lyon, Frankrike, 69003
- Rekruttering
- Novartis Investigative Site
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Beijing, Kina, 100144
- Rekruttering
- Novartis Investigative Site
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Selangor Darul Ehsan, Malaysia, 68100
- Rekruttering
- Novartis Investigative Site
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Johor
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Muar town, Johor, Malaysia, 84000
- Rekruttering
- Novartis Investigative Site
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Perak
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Ipoh, Perak, Malaysia, 30450
- Rekruttering
- Novartis Investigative Site
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10450
- Rekruttering
- Novartis Investigative Site
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Sabah
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Kota Kinabalu, Sabah, Malaysia, 88586
- Rekruttering
- Novartis Investigative Site
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Las Palmas GC, Spania, 35010
- Rekruttering
- Novartis Investigative Site
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Madrid, Spania, 28041
- Rekruttering
- Novartis Investigative Site
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Catalonia
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Barcelona, Catalonia, Spania, 08003
- Rekruttering
- Novartis Investigative Site
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Bochum, Tyskland, 44791
- Rekruttering
- Novartis Investigative Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Remibrutinib Dose A
Participants randomized during the core study to receive remibrutinib Dose A |
Remibrutinib Dose A and B (oral)
Andre navn:
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Eksperimentell: Remibrutinib Dose B
Participants randomized during the core study to receive remibrutinib Dose B |
Remibrutinib Dose A and B (oral)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline, up to Week 280
|
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa. |
Baseline, up to Week 280
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants with AN50/75/90 response
Tidsramme: Baseline, up to Week 276
|
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. |
Baseline, up to Week 276
|
|
Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4)
Tidsramme: Baseline, up to Week 276
|
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). |
Baseline, up to Week 276
|
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Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response
Tidsramme: Baseline, up to Week 276
|
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. |
Baseline, up to Week 276
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Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst
Tidsramme: Baseline, up to Week 276
|
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. |
Baseline, up to Week 276
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLOU064J12303B
- 2025-523259-72-00 (Annen identifikator: EU CTR)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
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