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Een studie om de werkzaamheid van remibrutinib te evalueren in vergelijking met dupilumab bij vroege tijdstippen bij volwassenen met chronische spontane urticaria die onvoldoende worden gecontroleerd door de tweede generatie H1-antihistamine (RECLAIM)

12 oktober 2026 bijgewerkt door: Novartis Pharmaceuticals

Een Amerikaanse fase 3B, multi-center, gerandomiseerde, dubbelblinde, dubbele dummy studie om de werkzaamheid van remibrutinib te evalueren in vergelijking met dupilumab bij vroege tijdstippen bij volwassenen met chronische spontane urticaria onvoldoende gecontroleerd door tweede generatie H1-antihistamine

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

409

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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])
Geneesmiddel: Remibrutinib

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

Geneesmiddel: Placebo solution for injection

Solution for injection in pre-filled syringe every 2 weeks
Actieve vergelijker: 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.)
Geneesmiddel: Remibrutinib matching placebo

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

Geneesmiddel: Dupilumab

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 juli 2025

Primaire voltooiing (Geschat)

22 februari 2027

Studie voltooiing (Geschat)

17 mei 2027

Studieregistratiedata

Eerst ingediend

6 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

6 maart 2025

Eerst geplaatst (Werkelijk)

10 maart 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLOU064AUS02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren