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En studie av Enpatoran hos deltakere med kutane manifestasjoner av lupus med eller uten systemisk sykdom (ELOWEN-1)

2. november 2026 oppdatert av: EMD Serono Research & Development Institute, Inc.

En fase 3, randomisert, dobbelblind, placebo-kontrollert parallellstudie for å vurdere effektiviteten og sikkerheten til Enpatoran hos deltakere med aktive kutane manifestasjoner av lupus erythematosus med eller uten systemisk sykdom som mottar standard behandling (Elowen-1)

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:

Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.

Intervention Form: Film-coated tablet.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

202

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • Rekruttering
        • John Hunter Hospital - PARENT
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Rekruttering
        • Rheumatology Research Unit Sunshine Coast
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Rekruttering
        • The Alfred Hospital - PARENT
  • Belgia
      • Leuven, Belgia, 03000
        • Rekruttering
        • UZ Leuven - Internal Medicine
  • Brasil
    • Ceará
      • Fortaleza, Ceará, Brasil, 60430-370
        • Rekruttering
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 40150-150
        • Rekruttering
        • Clínica SER da Bahia
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brasil, 78020-500
        • Rekruttering
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30150-221
        • Rekruttering
        • Freire Pesquisa Clinica
    • São Paulo
      • Barretos, São Paulo, Brasil, 14784400
        • Rekruttering
        • Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos
  • Bulgaria
      • Plovdiv, Bulgaria, 4023
        • Rekruttering
        • DCC V Plovdiv Sv. Archbishop Luka EOOD
      • Sofia, Bulgaria, 1407
        • Rekruttering
        • Ambulatory for Specialized Medical Help - skin and venereal diseases
  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90045
        • Rekruttering
        • Dermatology Research Associates - 300204025
      • Thousand Oaks, California, Forente stater, 91360
        • Rekruttering
        • Cohen Medical Centers
    • Florida
      • Cooper City, Florida, Forente stater, 33024
        • Rekruttering
        • GNP Research at Mark Jaffe, MD
      • Miami, Florida, Forente stater, 33135
        • Rekruttering
        • Advance Medical Research Center
      • Miami, Florida, Forente stater, 33175
        • Rekruttering
        • Diverse Clinical Research LLC
      • Tamarac, Florida, Forente stater, 33321
        • Rekruttering
        • D&H National Research Centers, Inc.
      • Tampa, Florida, Forente stater, 33606
        • Rekruttering
        • Clinical Research of West Florida, Inc.
    • Georgia
      • Atlanta, Georgia, Forente stater, 30303
        • Rekruttering
        • Emory University School of Medicine
    • Michigan
      • Troy, Michigan, Forente stater, 48084
        • Rekruttering
        • Revival Research Institute, LLC
    • Texas
      • Allen, Texas, Forente stater, 75013
        • Rekruttering
        • Allen Arthritis
      • Allen, Texas, Forente stater, 75013
        • Rekruttering
        • Arthritis and Rheumatology Research Institute PLLC
      • Corpus Christi, Texas, Forente stater, 78415
        • Rekruttering
        • Arthritis Care of Texas
  • Frankrike
      • Paris, Frankrike, 75020
        • Rekruttering
        • Hopital Tenon - service dermatologie et centre d'allergie
    • Pays de la Loire Region
      • Saint-Étienne-de-Montluc, Pays de la Loire Region, Frankrike, 42055
        • Rekruttering
        • CHU Saint Etienne - Hôpital Nord - service de medecine interne
  • Israel
      • Ramat Gan, Israel, 5265601
        • Rekruttering
        • Chaim Sheba Medical Center - pt
  • Italia
      • Roma, Italia, 00155
        • Rekruttering
        • Università Campus Bio-Medico di Roma - UOC Reumatologia
    • Firenze
      • Florence, Firenze, Italia, 50125
        • Rekruttering
        • Azienda USL Toscana Centro - Ospedale Piero Palagi
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • Rekruttering
        • JCHO Chukyo Hospital - Dept of Dermatology
    • Chiba
      • Chiba, Chiba, Japan, 260-8712
        • Rekruttering
        • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Rekruttering
        • Hospital of the University of Occupational and Environmental Health - Dept of Dermatology
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Rekruttering
        • Fukushima Medical University Hospital - Dept of Rheumatology/Immunology
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8644
        • Rekruttering
        • NHO Asahikawa Medical Center - Dept of Gastroenterology
      • Sapporo, Hokkaido, Japan, 060-8604
        • Rekruttering
        • Sapporo City General Hospital - Dept of Rheumatology/Immunology
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Rekruttering
        • Kobe University Hospital - Dept of Immunology/Rheumatology
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Rekruttering
        • Kanazawa University Hospital - Dept of Rheumatology/Immunology
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Rekruttering
        • Yokohama City University Hospital - Dept of Dermatology
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8512
        • Rekruttering
        • Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Rekruttering
        • Okayama University Hospital - Dept of Rheumatology/Immunology
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0871
        • Rekruttering
        • The University of Osaka Hospital - Dept of Dermatology
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Rekruttering
        • Institute of Science Tokyo Hospital - Dept of Dermatology
      • tabashi City, Tokyo, Japan, 173-8610
        • Rekruttering
        • Nihon University Itabashi Hospital - Dept of Hematology/Immunology
    • Tokyo-To
      • Chūōku, Tokyo-To, Japan, 104-8560
        • Rekruttering
        • St. Luke's International Hospital - Dept of Immunology/Allergy
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Rekruttering
        • University of Yamanashi Hospital - Dept of Rheumatology/Immunology
  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Rekruttering
        • Guangdong Provincial People's Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, Kina, 341000
        • Rekruttering
        • Ganzhou People's Hospital - 300165192
  • Polen
      • Krakow, Polen, 30-348
        • Rekruttering
        • Centrum Badan Klinicznych JCI
      • Lublin, Polen, 20-412
        • Rekruttering
        • ETG Lublin - ETG NETWORK Sp. z o.o.
      • Malbork, Polen, 82-200
        • Rekruttering
        • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
      • Rzeszów, Polen, 35-055
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej
      • Rzeszów, Polen, 35-309
        • Rekruttering
        • SOMED CR
      • Warsaw, Polen, 04-305
        • Rekruttering
        • REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
      • Zamość, Polen, 22-400
        • Rekruttering
        • Velocity Zamosc
  • Romania
      • Brasov, Romania, 500299
        • Rekruttering
        • Futuremeds S R L.
  • Slovakia
      • Bratislava, Slovakia, 81369
        • Rekruttering
        • Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto - Dermatovenerologicka klinika
      • Košice, Slovakia, 04011
        • Rekruttering
        • Artromac n.o. - Reumatologicka ambulancia
  • Spania
      • Valencia, Spania, 46014
        • Rekruttering
        • Hospital General Universitario de Valencia - Rheumatology
    • La Coruña
      • Santiago de Compostela, La Coruña, Spania, 15706
        • Rekruttering
        • Complejo Hospitalario Universitario de Santiago - Dermatology Unit
    • Navarre
      • Pamplona, Navarre, Spania, 31008
        • Rekruttering
        • Complejo Hospitalario de Navarra - Nefrologia
  • Storbritannia
    • Greater London
      • London, Greater London, Storbritannia, E11 1NR
        • Rekruttering
        • Whipps Cross University Hospital - Dept of Rheumatology
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, Storbritannia, NE7 7DN
        • Rekruttering
        • Freeman Hospital - Dept of Rheumatology
  • Sveits
      • Basel, Sveits, 4031
        • Rekruttering
        • Universitaetsspital Basel - Klinik fuer Dermatologie
      • Sankt Gallen, Sveits, 9000
        • Rekruttering
        • Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie
  • Sør -Korea
      • Incheon, Sør -Korea, 21565
        • Rekruttering
        • Gachon University Gil Medical Center
      • Seoul, Sør -Korea, 04763
        • Rekruttering
        • Hanyang University Seoul Hospital - 300186741
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Sør -Korea, 15355
        • Rekruttering
        • Korea University Ansan Hospital - 300133335
      • Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
  • Taiwan
      • Taichung, Taiwan, 404332
        • Rekruttering
        • China Medical University Hospital
      • Tainan, Taiwan, 71004
        • Rekruttering
        • Chi Mei Medical Center - 300192662
  • Thailand
      • Bangkok, Thailand, 10400
        • Rekruttering
        • Ramathibodi Hospital - 300195177
    • Changwat Pathum Thani
      • Amphur Klongluang, Changwat Pathum Thani, Thailand, 12120
        • Rekruttering
        • Thammasat University Hospital
  • Tyskland
      • Berlin, Tyskland, 10117
        • Rekruttering
        • Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie
      • Dresden, Tyskland, 01307
        • Rekruttering
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
    • Lower Saxony
      • Buxtehude, Lower Saxony, Tyskland, 21614
        • Rekruttering
        • Elbekliniken Buxtehude GmbH - Dermatologie

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 til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  • Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
  • Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).
  • Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.
  • Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.

For participants with SLE:

  • Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.
  • Participants with disease duration (cutaneous disease and, where applicable, SLE) of >= 6 months from time of diagnosis to Screening.
  • Participants with CLASI-A score >= 8 at Screening and Day 1 visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.
  • Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.
  • Participants with drug-induced lupus (SLE or CLE).
  • Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).
  • Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
  • Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.
  • Other protocol-defined exclusion criteria may apply.

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
Placebo komparator: Placebo
Legemiddel: Standard of care (SoC)

Participants will receive Investigator-recommended SoC.

Legemiddel: Placebo

Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Eksperimentell: Enpatoran
Legemiddel: Enpatoran

Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.

Andre navn:
  • M5049
Legemiddel: Standard of care (SoC)

Participants will receive Investigator-recommended SoC.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Prosentandel av deltakere med Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70-respons, definert som ≥ 70 prosent (%) reduksjon i CLASI-A-poengsum fra utgangspunkt
Tidsramme: Ved uke 24
Ved uke 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med behandlingsrelaterte bivirkninger (TEAEs), alvorlige bivirkninger (SAEs) og bivirkninger av spesiell interesse (AESI)
Tidsramme: Fra dag 1 til uke 24
Fra dag 1 til uke 24
Antall deltakere med abnormale (større enn og lik [≥] grad 3) laboratorieparametere
Tidsramme: Fra dag 1 til uke 24
Fra dag 1 til uke 24
Prosentandel av deltakere med CLASI-50-respons, definert som ≥50 % reduksjon i CLASI-A-poengsum fra baseline
Tidsramme: Ved uke 4 og 24
Ved uke 4 og 24
Prosentandel av deltakere med BILAG moderate til alvorlige oppblomstringer
Tidsramme: til uke 24
til uke 24
Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response
Tidsramme: At Week 24

A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to [<=] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and <= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than [<] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment).
At Week 24
Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24
Tidsramme: At Week 24

CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.
At Week 24
Percentage of Participants With BICLA Response and Clinically Meaningful Corticosteroid (CS) Reduction
Tidsramme: Day 1 up to Week 12 and thereafter upto Week 24

BICLA Response and clinically meaningful CS reduction, is defined as reduction of daily prednisone-equivalent dose from >= 10 milligrams (mg) at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.
Day 1 up to Week 12 and thereafter upto Week 24
Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24
Tidsramme: Baseline and at Week 24

The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from of 0 (no itch) to 10 (worst imaginable itch).
Baseline and at Week 24
Change from Baseline in CLASI-A Erythema at Week 24
Tidsramme: Baseline and at Week 24

CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.
Baseline and at Week 24
Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24
Tidsramme: Baseline and at Week 24

CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.
Baseline and at Week 24
Change from Baseline in CLASI-A Alopecia at Week 24
Tidsramme: Baseline and at Week 24

CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.
Baseline and at Week 24
Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24
Tidsramme: At Week 24

The CLA-IGA-R is assessed by the investigator, who assigns rater to assign scores to 3 individual domains (e.g. erythema, other morphologic characteristics - OMC [scales, edema)/infiltration and secondary change (vesicles, erosion, crusting)] and follicular activity). Clinicians assess the severity of the first 2 domains of erythema and OMC from 0 (Clear) to 4 (Severe); they assess the severity of the third domain of follicular activity as "absent" or "present." Higher scores indicate more disease activity.
At Week 24
Time to First Moderate/Severe BILAG Flare
Tidsramme: Day 1 up to 24 weeks

Median time to first moderate or severe BILAG Flare will be calculated.
Day 1 up to 24 weeks
Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose
Tidsramme: Day 1 up to 24 weeks

CS reduction is defined as reduction of daily prednisone-equivalent dose from >= 10 milligrams per day (mg/day) at Day 1 to <= 5 mg/day by the Week 12 visit and sustained through Week 24.
Day 1 up to 24 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

EMD Serono Research & Development Institute, Inc.

Samarbeidspartnere

Merck KGaA, Darmstadt, Germany

Etterforskere

  • Studieleder: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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.

Hjelpsomme linker

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)

10. mars 2026

Primær fullføring (Antatt)

24. mai 2029

Studiet fullført (Antatt)

24. mai 2029

Datoer for studieregistrering

Først innsendt

9. januar 2026

Først innsendt som oppfylte QC-kriteriene

9. januar 2026

Først lagt ut (Faktiske)

12. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MS504908_0001
  • 169831 (Annen identifikator: IND)
  • 2025-523871-44-00 (Ctis)
  • jRCT2011250064 (Annen identifikator: JRCT (Japan))
  • CTR20262380 (Annen identifikator: ChinaDrugTrials.org.cn)
  • 2025 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD supporting publicly available results will be evaluated for sharing.

IPD-delingstidsramme

IPD from completed trials will be publicly available within 6 months after all of the following events:

  • Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions
  • Public results via primary manuscript or trial registry disclosure
  • Legal authority to share data
  • Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21

Tilgangskriterier for IPD-deling

Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE
  • CSR

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