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En studie for å evaluere effektiviteten av remibrutinib sammenlignet med dupilumab på tidlige tidspunkter hos voksne med kronisk spontan urticaria utilstrekkelig kontrollert av andre generasjon H1-antihistaminer (RECLAIM)

12. oktober 2026 oppdatert av: Novartis Pharmaceuticals

En amerikansk fase 3B, multisenter, randomisert, dobbeltblind, dobbelt-dummy studie for å evaluere effekten av remibrutinib sammenlignet med dupilumab på tidlige tidspunkter hos voksne med kronisk spontan urticaria utilstrekkelig kontrollert av andre generasjon H1-antihistaminer

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

409

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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])
Legemiddel: Remibrutinib

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

Legemiddel: Placebo solution for injection

Solution for injection in pre-filled syringe every 2 weeks
Aktiv komparator: 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.)
Legemiddel: Remibrutinib matching placebo

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

Legemiddel: Dupilumab

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juli 2025

Primær fullføring (Antatt)

22. februar 2027

Studiet fullført (Antatt)

17. mai 2027

Datoer for studieregistrering

Først innsendt

6. mars 2025

Først innsendt som oppfylte QC-kriteriene

6. mars 2025

Først lagt ut (Faktiske)

10. mars 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLOU064AUS02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere