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Un estudio para evaluar la eficacia de remibrutinib en comparación con el dupilumab en puntos de tiempo tempranos en adultos con urticaria espontánea crónica controlada inadecuadamente por la segunda generación H1-antihistamines (RECLAIM)

12 de octubre de 2026 actualizado por: Novartis Pharmaceuticals

Un estudio de fase 3b, multicéntrico, aleatorizado, doble ciego, doble ciego, doble femenino, para evaluar la eficacia de remibrutinib en comparación con el dupilumab en puntos de tiempo tempranos en adultos con urticaria espontánea crónica controlada inadecuadamente por la segunda generación H1-antihistamines

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study consists of a screening period (up to 4 weeks), a core treatment period (12 weeks double-blind, double-dummy), an optional open-label extension [OLE] period, and safety follow-up period.

Screening period: participants will have a screening period of a minimum of 7 days up to a maximum of 28 days to establish eligibility for the study. Participants meeting all the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

Core treatment period (double-blind, double-dummy): approximately, 400 participants diagnosed with CSU inadequately controlled by sgH1-AH will be randomized in this study. Participants will be stratified based on prior exposure to anti-IgE biologics.

Eligible participants will be randomized in a 1:1 ratio to receive remibrutinib and placebo solution for injection or dupilumab and remibrutinib matching placebo, both as an add-on treatment to once daily standard label dose of sgH1-AH background therapy, until the Week 12 visit.

Additionally, all participants will be on a stable, standard label dose of a sgH1-AH ("background therapy") throughout the entire core treatment period (starting a minimum of 7 days prior to randomization until the end of Week 12). To treat unbearable symptoms of CSU, participants will be allowed to add more of the same sgH1-AH on an as-needed basis ("rescue therapy"). The total maximum daily dose of sgH1-AH (background plus rescue) should not exceed 4 tablets/day (4-fold the standard label dose).

Optional open-label extension [OLE] period: At the end of the 12-week double-blind treatment period, and in case remibrutinib is not commercially available, participants from both arms will be given the choice to roll over into an optional OLE safety period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).

Safety follow-up period:

  • For participants who do not enter the OLE period: there will be a safety follow-up for 12 weeks with safety follow-up phone calls at Week 16 and Week 24 (Week 24 will be end of study).
  • For participants who enter the OLE period: there will be 2 options at the end of Week 24:
  • If remibrutinib is commercially available: participants will discontinue study treatment, perform their EOT visit and receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
  • If remibrutinib is not commercially available, participants may continue on remibrutinib 25 mg b.i.d. until its commercial availability and return for site visits for safety follow up and treatment dispensation every 3 months. When remibrutinib becomes commercially available, the participant will be contacted for a site visit to complete the EOT visit and will receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).

Tipo de estudio

Intervencionista

Inscripción (Actual)

409

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35209
        • Allervie Clinical Research
      • Birmingham, Alabama, Estados Unidos, 35244
        • Cahaba Derm and skin hlth ctr 27
    • Arizona
      • Litchfield Park, Arizona, Estados Unidos, 85340
        • Research Solutions of Arizona
      • Payson, Arizona, Estados Unidos, 85541
        • Peak Dermatology
      • Phoenix, Arizona, Estados Unidos, 85032
        • Premier Allergy Asthma And Immunology
      • Scottsdale, Arizona, Estados Unidos, 85254
        • Orso Health
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Acuro Research Inc
    • California
      • Fountain Valley, California, Estados Unidos, 92708
        • First OC Dermatology
      • Fremont, California, Estados Unidos, 95438
        • Ctr for Dermatology Clinical Res
      • Huntington Beach, California, Estados Unidos, 92647
        • Allergy and Asthma Specialists Group
      • Long Beach, California, Estados Unidos, 90808
        • Orso Health
      • Long Beach, California, Estados Unidos, 90815
        • Ark Clinical Research
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
      • Los Angeles, California, Estados Unidos, 90025
        • California Allergy and Asthma Medical Group
      • Napa, California, Estados Unidos, 94558
        • One Of A Kind Clinical Research
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford University Medical Center
      • Pomona, California, Estados Unidos, 91767
        • Empire Clinical Research
      • Redwood City, California, Estados Unidos, 94063
        • Allergy and Asthma Consultants
      • Rocklin, California, Estados Unidos, 95765
        • Norcal Clinical Research
      • Rolling Hills Estates, California, Estados Unidos, 90274
        • Peninsula Research Associates
      • Sacramento, California, Estados Unidos, 95815
        • Integrative Skin Science and Res
      • Sacramento, California, Estados Unidos, 95817
        • UC Davis Neuromuscular Research Center
      • San Diego, California, Estados Unidos, 92123
        • Therapeutics Clinical Research
      • Santa Monica, California, Estados Unidos, 90403
        • Dermatology Institute and Skin Care
      • Upland, California, Estados Unidos, 91786
        • Integrated Research of Inland Inc
      • Walnut Creek, California, Estados Unidos, 94598
        • Allergy and Asthma Clin Res Inc
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Hospital - Aurora
      • Colorado Springs, Colorado, Estados Unidos, 80909
        • Colorado ENT and Allergy
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Asthma and Allergy Associates P C
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20059
        • Howard University Hospital Division of Geriatrics
    • Florida
      • Aventura, Florida, Estados Unidos, 33180
        • Florida Ctr Allergy Asthma Research
      • Boca Raton, Florida, Estados Unidos, 33486
        • Skin Care Research Inc
      • Doral, Florida, Estados Unidos, 33172
        • Omnicure Clinical Research
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • FXM Clinical Research Ft Laud
      • Hollywood, Florida, Estados Unidos, 33021
        • Skin Care Research LLC
      • Jacksonville, Florida, Estados Unidos, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, Estados Unidos, 33176
        • Miami Dade Medical Research
      • Miami, Florida, Estados Unidos, 33125
        • University of MiamiHealth System
      • Miami, Florida, Estados Unidos, 33175
        • FXM Clinical Res Miami LLC
      • Miramar, Florida, Estados Unidos, 33027
        • Eminat LLC
      • North Miami Beach, Florida, Estados Unidos, 33162
        • Ziaderm Research LLC
      • Panama, Florida, Estados Unidos, 32405
        • AllerVie Health
      • Sarasota, Florida, Estados Unidos, 34233
        • Sarasota Clinical Research
      • Sweetwater, Florida, Estados Unidos, 33172
        • Lenus Research and Med Group LLC
      • Tampa, Florida, Estados Unidos, 33613
        • Asthma Allergy Immunology Clin Res
      • Winter Park, Florida, Estados Unidos, 32789
        • Conquest Research
    • Georgia
      • Columbus, Georgia, Estados Unidos, 31904
        • AllerVie Clin Res Columbus GA
      • Cumming, Georgia, Estados Unidos, 30040
        • Cleaver Medical Group
      • Douglasville, Georgia, Estados Unidos, 30135
        • Southeast Dermatology Specialists
      • Savannah, Georgia, Estados Unidos, 31406
        • Aeroallergy Research Laboratories
    • Idaho
      • Meridian, Idaho, Estados Unidos, 83642
        • The Allergy Group-Meridian Clinic
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Estados Unidos, 60611
        • NW Uni C and T Sciences Ins
      • Normal, Illinois, Estados Unidos, 61761
        • Midwest Allergy Sinus Asthma SC
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Clinical Res Ctr of S Illinois
      • River Forest, Illinois, Estados Unidos, 60305
        • Asthma and Allergy Center of Chicago S C
      • Skokie, Illinois, Estados Unidos, 60077
        • Endeavor Health Clinical Trials Center
      • Wheaton, Illinois, Estados Unidos, 60189
        • Accellacare Duly Health and Care
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47715
        • Deaconess Clin Allerg Res Inst
      • New Albany, Indiana, Estados Unidos, 47150
        • Southern IN Clinical Trials
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • McFarland Clinic PC
    • Kentucky
      • Bowling Green, Kentucky, Estados Unidos, 42104
        • Equity Medical LLC
      • Louisville, Kentucky, Estados Unidos, 40215
        • Family Allergy And Asthma Rsch Inst
      • Owensboro, Kentucky, Estados Unidos, 42301
        • Allergy and Asthma Specialist P S C
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70816
        • Ochsner Health Center
      • Lafayette, Louisiana, Estados Unidos, 70508
        • Velocity Clinical Research
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21236
        • Chesapeake Clinical Research Inc
      • Baltimore, Maryland, Estados Unidos, 21205
        • Johns Hopkins U School of Med
      • Chevy Chase, Maryland, Estados Unidos, 20815
        • Institute for Asthma and Allergy PC
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Boston Specialists LLC
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106-0525
        • ClinSite Inc
      • Caledonia, Michigan, Estados Unidos, 49316
        • Derm Institute West Michigan PLLC
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Hospital
      • Troy, Michigan, Estados Unidos, 48084
        • Somerset Skin Centre
      • Troy, Michigan, Estados Unidos, 48084
        • Revival Research Institute
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Clinical Research Institute
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic - Rochester
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65201
        • ENT and Allergy Center of Missouri
      • St Louis, Missouri, Estados Unidos, 63141
        • The Clinical Research Center
      • St Louis, Missouri, Estados Unidos, 63141
        • Washington University
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Somnos Clinical Research
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Las Vegas Dermatology
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Allergy and Asthma Center of Las Vegas
    • New Jersey
      • Hamilton, New Jersey, Estados Unidos, 08619
        • Circuit Clinical Mercer Algy Pulm
      • Little Silver, New Jersey, Estados Unidos, 07739
        • Allergy Asthma Assoc Monmouth
      • Ocean Township, New Jersey, Estados Unidos, 07712
        • Allergy Partners of New Jersey PC
    • New York
      • The Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center
      • The Bronx, New York, Estados Unidos, 10455
        • Equity Medical
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Allergy Partners Of West NC
      • Chapel Hill, North Carolina, Estados Unidos, 27516
        • UNC DermatologyandSkinCancer Ctr
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45231
        • Bernstein Clinical Research Center
      • Columbus, Ohio, Estados Unidos, 43213
        • CR Services Acquisition US
      • Fairborn, Ohio, Estados Unidos, 45324
        • Wright State University
      • Toledo, Ohio, Estados Unidos, 43617
        • Toledo Institute of Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Vital Prospects Clinical Research Institute
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health Sciences University
      • Portland, Oregon, Estados Unidos, 97223
        • Oregon Medical Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15241
        • Allergy and Clinical Immunology Associates
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29607
        • Allergic Disease and Asthma Center
      • Greenville, South Carolina, Estados Unidos, 29601
        • Tribe Clinical Research LLC
      • North Charleston, South Carolina, Estados Unidos, 29420
        • National Allergy and Asthma Research LLS
      • North Charleston, South Carolina, Estados Unidos, 29406
        • Charleston ENT and Allergy
    • Tennessee
      • Goodlettsville, Tennessee, Estados Unidos, 37072-2301
        • Goodlettsville Dermatology Research
      • Murfreesboro, Tennessee, Estados Unidos, 37130
        • International Clinical Research Tennessee LCC
    • Texas
      • Arlington, Texas, Estados Unidos, 76011
        • Arlington Center for Dermatology
      • Austin, Texas, Estados Unidos, 78759
        • Orion Clinical Research
      • Bellaire, Texas, Estados Unidos, 77401
        • Bellaire Dermatology Associates
      • Dallas, Texas, Estados Unidos, 75230
        • Reveal Research Institute
      • Dallas, Texas, Estados Unidos, 75231
        • Pharma Research and Amp Consult
      • El Paso, Texas, Estados Unidos, 79924
        • Western Sky Medical Research
      • Houston, Texas, Estados Unidos, 77030
        • Center for Clinical Studies
      • Kerrville, Texas, Estados Unidos, 78028
        • Sante Clinical Research
      • San Antonio, Texas, Estados Unidos, 78229
        • Andante Research
      • San Antonio, Texas, Estados Unidos, 78213
        • RFSA Dermatology
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • University Of Utah
      • Sandy City, Utah, Estados Unidos, 84093
        • Allergy Associates of Utah
    • Virginia
      • Vienna, Virginia, Estados Unidos, 22182
        • Forefront Dermatology
    • Washington
      • Bellingham, Washington, Estados Unidos, 98225
        • Bellingham Asthma Allergy and Immunology

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults ≥ 18 years of age at the time of signing the informed consent
  • CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
  • Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:
  • The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
  • UAS7 score (range, 0-42) ≥ 16, and
  • ISS7 score (range, 0-21) ≥ 6, and
  • HSS7 score (range, 0-21) ≥ 6
  • Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history
  • Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol
  • Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)

Exclusion Criteria:

  • Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
  • Previous use of dupilumab
  • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
  • Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)
  • History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)
  • Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
  • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants [NOAC])
  • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) > 1.5 at screening

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment group 1: Remibrutinib + Placebo

Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week [Weeks 2-10])
Droga: Remibrutinib

Film-coated tablet, oral administration, 25 mg b.i.d.

Droga: Placebo solution for injection

Solution for injection in pre-filled syringe every 2 weeks
Comparador activo: Treatment group 2: Dupilumab + remibrutinib matching placebo

Dupilumab pre-filled syringe (600 mg loading dose [2 x 300 mg dupilumab s.c. injection] at baseline visit followed by dupilumab 300 mg s.c. injection every other week [Weeks 2-10]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)
Droga: Remibrutinib matching placebo

Film-coated tablet, oral administration, b.i.d.

Droga: Dupilumab

Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Periodo de tiempo: Baseline, Week 4

The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Baseline, Week 4

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
Periodo de tiempo: Baseline, Week 4

The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.
Baseline, Week 4
Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 4
Periodo de tiempo: Baseline, Week 4

The severity of the itch will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.
Baseline, Week 4
Improvement of UAS7, assessed as absolute change from baseline in UAS7 score at Week 1
Periodo de tiempo: Baseline, Week 1

The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Baseline, Week 1
Percentage of participants with UAS7 ≤ 6 at Week 4
Periodo de tiempo: Week 4

Percentage of participants who achieved UAS7 ≤ 6 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 4
Percentage of participants with UAS7=0 at Week 4
Periodo de tiempo: Week 4

Percentage of participants who achieved UAS7 = 0 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 4
Percentage of participants with UAS7 ≤ 6 at Week 2
Periodo de tiempo: Week 2

Percentage of participants who achieved UAS7 ≤ 6 at Week 2. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 2

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de julio de 2025

Finalización primaria (Estimado)

22 de febrero de 2027

Finalización del estudio (Estimado)

17 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

6 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2025

Publicado por primera vez (Actual)

10 de marzo de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CLOU064AUS02

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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