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Studie av M5049 i DM- og PM-deltakere (NEPTUNIA)

17. august 2026 oppdatert av: EMD Serono Research & Development Institute, Inc.

En fase IIa, randomisert, parallell, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Enpatoran ved deltakere i dermatomyositt og polymyositt som mottar standardbehandling (NEPTUNIA)

Formålet med denne studien er å evaluere effektiviteten og sikkerheten til oralt administrert M5049 i idiopatiske inflammatoriske myopatier, spesielt dermatomyositt (DM) og polymyositt (PM) deltakere i 24 uker.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85028
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Forente stater, 85251
        • HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic Scottsdale (6365)
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Barbara Davis Center
    • Florida
      • Orlando, Florida, Forente stater, 32819
        • HMD Research LLC
      • Pembroke Pines, Florida, Forente stater, 33026
        • Bolanos Clinical Research
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Augusta University-Rheumatology
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Johns Hopkins University - Department of Medicine, Division of Rheumatology
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota-Dermatology
    • Missouri
      • Kansas City, Missouri, Forente stater, 66103
        • University of Kansas Medical Center-Neuromuscular
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh
    • Texas
      • Austin, Texas, Forente stater, 78759
        • Austin Neuromuscular Center
      • Houston, Texas, Forente stater, 77030
        • Nerve and Muscle Center of Texas-Clinical research
  • Hellas
      • Athens, Hellas
        • Hippokration Hospital - 2nd Department of Medicine and Laboratory
      • Athens, Hellas
        • National and Kapodistrian University of Athens (Egnitio Hospital)
      • Larissa, Hellas
        • University General Hospital of Larissa
  • Italia
      • Catania, Italia
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
      • Catania, Italia
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
      • Florence, Italia
        • Azienda Usl Toscana Centro
      • Reggio Emilia, Italia
        • Arcispedale S. Maria Nuova
      • Rome, Italia
        • Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
  • Polen
      • Warsaw, Polen
        • Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
  • Spania
      • A Coruña, Spania
        • CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
      • Barcelona, Spania
        • Hospital Vall d'hebrón
      • Madrid, Spania
        • Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department
  • Storbritannia
      • Doncaster, Storbritannia
        • Doncaster Royal Infirmary (3466)
      • London, Storbritannia
        • Royal Free London NHS Foundation Trust
      • London, Storbritannia
        • University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
      • Salford, Storbritannia
        • Salford Royal Hospital, Barnes Clinical Research Facility
      • Wolverhampton, Storbritannia
        • Royal Wolverhampton Hospitals (6493)
  • Tsjekkia
      • Prague, Tsjekkia
        • Institute of Rheumatology - Rheumatology

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

Beskrivelse

Inklusjonskriterier:

  • Diagnose av sannsynlig eller sikker DM eller PM i henhold til 2017 ACR/EULAR klassifiseringskriterier, med positiv autoantistoffstatus. Deltakere med PM må oppfylle klassifiseringskriterier med muskelbiopsi. Deltakere i antisyntetasesyndrom (ASyS) som oppfyller klassifiseringskriteriene er tillatt
  • Aktiv sykdom på standardbehandling (SoC), må oppfylle ett av kriteriene innen 6 måneder før screening: Patologisk bevis på aktiv myositt i muskelbiopsi; Bevis på aktiv myositt ved elektromyografi (EMG); Magnetisk resonansavbildning (MRI) med tegn på aktiv myositt; eller ethvert muskelenzym større enn eller lik (>=) 4 × øvre normalgrense (ULN) på tidspunktet for screening; Aktivt PM/DM hudutslett i henhold til kutan dermatomyositt-område og alvorlighetsindeks-A (CDASI-A) >= 7 på tidspunktet for screening
  • Minimum alvorlighetsgrad av sykdom definert av: moderat til alvorlig myopati med manuell muskeltesting-8 (MMT-8) >= 80 og mindre enn eller lik (= 2 centimeter (cm); Physician Global Activity (PGA) avledet fra vurdering av myositt sykdomsaktivitet verktøy (MDAAT) >= 2 cm; Ekstramuskulær aktivitetsvurdering avledet fra MDAAT >= 2 cm; Minst ett muskelenzym > 1,5 ganger ULN; helsevurdering spørreskjema-funksjonshemmingsindeks (HAQ-DI) >= 0,25 ELLER moderat til alvorlig utslett og mild myopati med MMT-8 mellom 137 og = 14 OG minst 2 av følgende CSM-avvik: PtGA >= 2 cm; PGA avledet fra MDAAT >= 2 cm; Ekstramuskulær aktivitetsvurdering avledet fra MDAAT >= 2 cm; Minst én muskelenzym > 1,5 ganger ULN; HAQ-DI >= 0,25
  • Stabile doser av orale kortikosteroider (CS) og/eller maksimalt 1 ikke-kortikosteroid immunsuppressive/immunmodulerende medisiner (metotreksat, 6 merkaptopurin, sulfasalazin, mykofenolatmofetil eller natrium, azatioprin, leflunomid, ciklosporin, oral tacrolim eller oral tacrolim)
  • Deltakerne har en kroppsmasseindeks (BMI) innenfor området 18,5 til 35,0 kilogram per kvadratmeter (kg/m^2) (inkludert)
  • Andre protokolldefinerte inklusjonskriterier kan gjelde

Ekskluderingskriterier:

  • Primærdiagnose av inklusjonskroppsmyositt (IBM), malignitetsassosiert myositt (definert som diagnose av myositt innen 3 år etter kreft), immunmediert nekrotiserende myopati (IMNM) med en biopsi karakterisert som nekrotiserende biopsi eller IMNM med positiv anti-signalgjenkjenningspartikkel antistoff (SRP) eller anti-3-hydroksy-3-metylglutaryl-koenzym A-reduktase (HMGCR) auto-antistoffer. Deltakere med anti-transkripsjon intermediær faktor 1 (TIF1) gamma-antistoff eller nydiagnostisert (innen 1 år) anti MDAT5-antistoff bør ha hatt tilstrekkelig screening for kreft innen 12 måneder etter dag 1. Adekvat screening av kreft er definert som oppdatert alder og kjønn passende screening i henhold til nasjonale retningslinjer
  • Primærdiagnose av juvenil DM, eller voksne deltakere tidligere diagnostisert med juvenil DM
  • Enhver annen aktiv samtidig bindevevssykdom assosiert med inflammatorisk myopati etter etterforskerens mening. Kvalifisering for deltakere med diagnose av samtidig(e) bindevevssykdom(er) vil bli vurdert og godkjent av en ekspertkomité for idiopatiske inflammatoriske myopatier (IIM).
  • Alvorlig interstitiell lungesykdom definert som ekstra oksygen nødvendig i hvile, eller tvungen vital kapasitet (FVC) av
  • Enhver ukontrollert sykdom (for eksempel [f.eks.], alvorlig respiratorisk, kardiovaskulær, gastrointestinal, nevrologisk, psykiatrisk, hematologisk, metabolsk [inkludert tyreoiditt med økt/redusert thyreoideastimulerende hormon (TSH)], nyre-, lever-, endokrine/reproduktive organsykdom andre) enn DM/PM, som etter etterforskerens eller sponsorens/designerens mening utgjør en upassende risiko eller kontraindikasjon for deltakelse i studien eller som kan forstyrre studiens mål, oppførsel eller evaluering
  • Andre protokolldefinerte eksklusjonskriterier kan gjelde

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: DBPC-periode: Placebo
Legemiddel: Placebo
Deltakerne vil motta placebo tilpasset M5049 oralt, to ganger daglig i opptil 24 uker.
Eksperimentell: Double-blind Placebo Controlled (DBPC) Period: M5049 dose
Legemiddel: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Andre navn:
  • Enpatoran
Eksperimentell: Open Label Extension (OLE) Period: M5049 dose
Legemiddel: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Andre navn:
  • Enpatoran

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Double Blind Placebo Control Period (DBPC): American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Tidsramme: At Week 24 (end of DBPC period)
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>= 40) and major(>= 60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 24 (end of DBPC period)
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Tidsramme: Up to Week 26 (Safety follow up)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
Tidsramme: Up to Week 26 (Safety follow up)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Tidsramme: Up to Week 26 (Safety follow up)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)
DBPC Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
Tidsramme: Up to Week 26 (Safety follow up)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
Up to Week 26 (Safety follow up)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DBPC Period: Number of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
Tidsramme: At Week 16 and Week 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and Week 24
DBPC Period: Participant's Total Improvement Score (TIS)
Tidsramme: Week 4, 8, 12, 16, 20 and 24
The ACR/EULAR TIS was derived from evaluation of results from 6 Core Set Measures(CSMs) of myositis disease activity in participants with Dermatomyositis and Polymyositis.TIS was determined by summing scores for each CSM,based on improvement in absolute percent change which is calculated by subtracting the baseline value from the final value,dividing difference by the range, and then multiplying the result by100 and relative weight of each core set measure. The TIS scale ranges from 0 to 100 with thresholds for minimal [more than or equal to(>= 20)],moderate(>=40) and major(>=60)improvement in combined 6 CSM.The CSMs include,physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index(0-3) along with checks for most abnormal muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Physician Global Activity (PGA) Scores From Myositis Disease Activity Assessment Tool (MDAAT)
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
The Physician's Global Assessment of Disease Activity was an assessment of overall global disease activity by the physician that was taken from Myositis Disease Activity Assessment Tool (MDAAT). Physician rated participant's disease activity on a 0-10 centimeter (cm) visual analog scale (VAS). Extra-muscular activity ranged between 0 and 10, where, 0 cm = absent and 10 cm = maximum disease activity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Patient Global Activity (PtGA) Visual Analog Scale (VAS) Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Extra Muscular Global Assessment From Myositis Disease Activity Assessment Tool (MDAAT) Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
MDAAT was a combined tool capturing physician's assessment of disease activity of various organ systems- constitutional, cutaneous, pulmonary, gastrointestinal, joints and cardiovascular, muscular using: Myositis Intention to Treat Activity Index (MITAX), a scale from 0("Not present in the last 4 weeks") to 4("New - in the last 4 weeks [compared to the previous 4 weeks]") and Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), a 10 cm VAS assessing disease activity in the last 4 weeks of various organ systems from 0 cm("No evidence of disease activity") to 10 cm("Extremely active or severe disease activity"), disease activity being defined as potentially reversible pathology or physiology resulting from the myositis. Left end of line = no evidence of disease activity, midpoint of line = moderate disease activity, and right end of line = extreme or maximum disease activity. An assessment of extramuscular activity assessment was taken from MDAAT using a 10cm VAS scale.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Manual Muscle Testing-8 (MMT-8) Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
MMT-8 was an International Myositis Assessment and Clinical Studies (IMACS) Core Set Measure used in the calculation of the IMACS Definition of Improvement (DOI) and ACR/EULAR TIS. It is a set of 8 designated muscles tested unilaterally (generally on right side) -which include 1 axial, 5 proximal (2 upper extremity, 3 lower extremity), and 2 distal muscles (1 upper, 1 lower extremity). Total score for unilateral testing ranges from 0 to 80, and bilateral testing ranges from 0 to 150 with normal strength represented by a higher score at or near the top of the scale. The total score for bilateral testing (item "MMT8 score (0 - 150)" from the MANUAL MUSCLE TESTING-8 (mmt8) form) is used in the derivation of the Total Improvement Score.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI) Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
HAQ-DI was an IMACS Core Set Measure used in the calculation of the IMACS DOI and ACR/EULAR TIS. It is a generic rather than a disease-specific instrument comprised of 8 sections (dressing, arising, eating, walking, hygiene, reach, grip, and activities), with 2 to 3 questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8. Overall score ranges from 0-3.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Relative Change From Baseline in Most Abnormal Muscle-associated Enzyme
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
For each participant, the most abnormal muscle-associated enzyme was defined as the baseline muscle-associated enzyme with the highest ratio of the observed value to the upper limit of the normal range (ULN) among creatinine kinase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and aldolase. The relative abnormality could be expressed as a percentage of ULN, calculated as (enzyme value divided by ULN) multiplied by 100.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Number of Participants Who Achieved International Myositis Assessment and Clinical Studies (IMACS) Response
Tidsramme: At Week 16 and 24
A participant was defined as an International Myositis Assessment and Clinical Studies (IMACS) Responder if 3 of any 6 IMACS Core Set Measures (CSMs) have been improved by more than equal to (>= 20) percent (%), with no more than 2 IMACS CSMs worse by >= 25%. The CSMs include, physician global activity visual analogue scale(VAS) score(0-10), patient global activity VAS score(0-10), manual muscle testing-8 score(0-150), health assessment questionnaire-disability index (0-3) along with checks for muscle-associated enzymes and extra muscular activity assessment derived using myositis disease activity assessment tool(0-10).
At Week 16 and 24
DBPC Period: Change From Baseline in Cutaneous Dermatomyositis Area and Severity Index-A (CDASI-A) and Cutaneous Dermatomyositis Area and Severity Index-D (CDASI-D) Subscale Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM participants. CDASI has 3 activity measures (CDASI-A: erythema, scale, and erosion/ulceration) and 2 damage measures (CDASI-D: poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands, periungual changes and alopecia are evaluated separately both for activity and damage. Activity and Damage Subscale scores range from 0 to 100 and 0 to 32, respectively, where higher scores indicate greater disease severity.
Baseline, Week 4, 8, 12, 16, 20 and 24
DBPC Period: Change From Baseline in Investigator's Global Assessment (IGA) Skin Activity Score
Tidsramme: Baseline, Week 4, 8, 12, 16, 20 and 24
The IGA skin activity is a five-point score that defines the level of disease severity based on overall lesion characteristics where 0 is "clear" and "4" is severe.
Baseline, Week 4, 8, 12, 16, 20 and 24
Open-label Extension (OLE) Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Tidsramme: From start of OLE period (Week 1) up to safety follow up (Week 26)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Laboratory Parameters
Tidsramme: From start of OLE period (Week 1) up to safety follow up (Week 26)
Laboratory parameters included hematology, biochemistry, urinalysis and reflex testing for HBV DNA. Number of participants with clinically meaningful changes from baseline in laboratory parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Tidsramme: From start of OLE period (Week 1) up to safety follow up (Week 26)
Vital signs included body temperature, systolic and diastolic blood pressure, respiration rate, pulse rate, weight, height and body mass index. Number of participants with clinically meaningful changes from baseline in vital signs were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)
OLE Period: Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECG) Parameters
Tidsramme: From start of OLE period (Week 1) up to safety follow up (Week 26)
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Number of participants with clinically meaningful changes from baseline in ECG parameters were reported. Clinical meaningfulness was assessed by the investigator.
From start of OLE period (Week 1) up to safety follow up (Week 26)

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)

19. januar 2023

Primær fullføring (Faktiske)

25. juni 2025

Studiet fullført (Faktiske)

25. juni 2025

Datoer for studieregistrering

Først innsendt

6. desember 2022

Først innsendt som oppfylte QC-kriteriene

6. desember 2022

Først lagt ut (Faktiske)

14. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MS200569_0041
  • 2022-501351-82-00 (Annen identifikator: EUCT number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Vi er forpliktet til å forbedre folkehelsen gjennom ansvarlig deling av data fra kliniske forsøk. Etter godkjenning av et nytt produkt eller en ny indikasjon for et godkjent produkt i både USA og EU, vil studiesponsoren og/eller dens tilknyttede selskaper dele studieprotokoller, anonymiserte pasientdata og studienivådata, og redigerte kliniske studierapporter med kvalifiserte vitenskapelige og medisinske forskere, på forespørsel, etter behov for å utføre legitim forskning. Ytterligere informasjon om hvordan du ber om data finner du på vår nettside bit.ly/IPD21

IPD-delingstidsramme

Innen seks måneder etter godkjenning av et nytt produkt eller en ny indikasjon for et godkjent produkt i både USA og EU

Tilgangskriterier for IPD-deling

Kvalifiserte vitenskapelige og medisinske forskere kan be om dataene. Slike forespørsler skal sendes skriftlig til virksomhetens portal og vil bli internt gjennomgått med hensyn til kriterier for forskeres kvalifisering og legitimitet av forskningsforslaget.

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

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