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Studie av M5049 i DM och PM-deltagare (NEPTUNIA)

17 augusti 2026 uppdaterad av: EMD Serono Research & Development Institute, Inc.

En fas IIa, randomiserad, parallell, dubbelblind, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten av Enpatoran vid deltagare i dermatomyosit och polymyosit som får standardvård (NEPTUNIA)

Syftet med denna studie är att utvärdera effektiviteten och säkerheten av oralt administrerad M5049 vid idiopatiska inflammatoriska myopatier, specifikt dermatomyosit (DM) och polymyosit (PM) deltagare under 24 veckor.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Diagnos av trolig eller säker DM eller PM enligt 2017 ACR/EULAR klassificeringskriterier, med positiv autoantikroppsstatus. Deltagare med PM måste uppfylla klassificeringskriterier med muskelbiopsi. Antisyntetassyndrom (ASyS) deltagare som uppfyller klassificeringskriterier är tillåtna
  • Aktiv sjukdom på standardvård (SoC), måste uppfylla ett av kriterierna inom 6 månader före screening: Patologiska bevis på aktiv myosit i muskelbiopsi; Bevis på aktiv myosit genom elektromyografi (EMG); Magnetisk resonanstomografi (MRT) med tecken på aktiv myosit; eller något muskelenzym som är större än eller lika med (>=) 4 × övre normalgräns (ULN) vid tidpunkten för screening; Aktiva PM/DM hudutslag enligt kutan dermatomyosit område och svårighetsgrad index-A (CDASI-A) >= 7 vid tidpunkten för screening
  • Minsta svårighetsgrad av sjukdomen definierad av: måttlig till svår myopati med manuell muskeltestning-8 (MMT-8) >= 80 och mindre än eller lika med (= 2 centimeter (cm); Physician Global Activity (PGA) härledd från myosit sjukdomsaktivitetsbedömning verktyg (MDAAT) >= 2 cm; Extramuskulär aktivitetsbedömning härledd från MDAAT >= 2 cm; Minst ett muskelenzym > 1,5 gånger ULN; hälsobedömning frågeformulär-invaliditetsindex (HAQ-DI) >= 0,25 ELLER måttliga till svåra utslag och mild myopati med MMT-8 mellan 137 och = 14 OCH minst 2 av följande CSM-avvikelser: PtGA >= 2 cm; PGA härlett från MDAAT >= 2 cm; Extramuskulär aktivitetsbedömning härledd från MDAAT >= 2 cm; Minst en muskelenzym > 1,5 gånger ULN; HAQ-DI >= 0,25
  • Stabila doser av orala kortikosteroider (CS) och/eller maximalt 1 icke-kortikosteroid immunsuppressiva/immunmodulerande läkemedel (metotrexat, 6 merkaptopurin, sulfasalazin, mykofenolatmofetil eller natrium, azatioprin, leflunomid, ciklosporin, oralt tacrolim eller oralt tacrolim)
  • Deltagarna har ett kroppsmassaindex (BMI) inom intervallet 18,5 till 35,0 kilogram per kvadratmeter (kg/m^2) (inklusive)
  • Andra protokolldefinierade inklusionskriterier kan gälla

Exklusions kriterier:

  • Primär diagnos av inklusionskroppsmyosit (IBM), malignitetsassocierad myosit (definierad som diagnos av myosit inom 3 år efter cancer), immunmedierad nekrotiserande myopati (IMNM) med en biopsi karakteriserad som nekrotiserande biopsi eller IMNM med positiv anti-signaligenkänningspartikel antikropp (SRP) eller anti-3-hydroxi-3-metylglutaryl-koenzym A-reduktas (HMGCR) autoantikroppar. Deltagare med anti-transkriptions intermediär faktor 1 (TIF1) gammaantikropp eller nydiagnostiserad (inom 1 år) anti MDAT5 antikropp bör ha genomgått adekvat screening för cancer inom 12 månader från dag 1. Adekvat screening av cancer definieras som uppdaterad ålders- och könsanpassad screening enligt nationella riktlinjer
  • Primär diagnos av juvenil DM, eller vuxna deltagare som tidigare diagnostiserats med juvenil DM
  • Alla andra aktiva samtidiga bindvävssjukdomar associerade med inflammatorisk myopati enligt utredarens åsikt. Behörighet för deltagare med diagnos av samtidig(a) bindvävssjukdom(ar) kommer att granskas och godkännas av en expertkommitté för idiopatiska inflammatoriska myopatier (IIM).
  • Allvarlig interstitiell lungsjukdom definierad som extra syre som krävs i vila, eller forcerad vitalkapacitet (FVC) av
  • Alla okontrollerade sjukdomar (till exempel [t.ex.], allvarliga andningsvägar, kardiovaskulära, gastrointestinala, neurologiska, psykiatriska, hematologiska, metabola [inklusive tyreoidit med ökat/minskat sköldkörtelstimulerande hormon (TSH)], njur-, lever-, endokrina/reproduktiva organsjukdomar andra) än DM/PM, som enligt utredarens eller sponsorns/designerades åsikt utgör en olämplig risk eller kontraindikation för deltagande i studien eller som kan störa studiens mål, uppförande eller utvärdering
  • Andra protokolldefinierade uteslutningskriterier kan gälla

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: DBPC-period: Placebo
Läkemedel: Placebo
Deltagarna kommer att få placebo som matchas till M5049 oralt, två gånger dagligen upp till 24 veckor.
Experimentell: Double-blind Placebo Controlled (DBPC) Period: M5049 dose
Läkemedel: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Andra namn:
  • Enpatoran
Experimentell: Open Label Extension (OLE) Period: M5049 dose
Läkemedel: M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Andra namn:
  • Enpatoran

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Double Blind Placebo Control Period (DBPC): American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

EMD Serono Research & Development Institute, Inc.

Samarbetspartners

Merck KGaA, Darmstadt, Germany

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 januari 2023

Primärt slutförande (Faktisk)

25 juni 2025

Avslutad studie (Faktisk)

25 juni 2025

Studieregistreringsdatum

Först inskickad

6 december 2022

Först inskickad som uppfyllde QC-kriterierna

6 december 2022

Första postat (Faktisk)

14 december 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MS200569_0041
  • 2022-501351-82-00 (Annan identifierare: EUCT number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Vi har åtagit oss att förbättra folkhälsan genom ansvarsfull delning av data från kliniska prövningar. Efter godkännande av en ny produkt eller en ny indikation för en godkänd produkt i både USA och Europeiska unionen, kommer studiesponsorn och/eller dess anslutna företag att dela studieprotokoll, anonymiserade patientdata och studienivådata och redigerade kliniska studierapporter med kvalificerade vetenskapliga och medicinska forskare, på begäran, som behövs för att bedriva legitim forskning. Mer information om hur du begär data finns på vår hemsida bit.ly/IPD21

Tidsram för IPD-delning

Inom sex månader efter godkännandet av en ny produkt eller en ny indikation för en godkänd produkt i både USA och EU

Kriterier för IPD Sharing Access

Kvalificerade vetenskapliga och medicinska forskare kan begära uppgifterna. Sådana förfrågningar ska lämnas skriftligen till företagets portal och kommer att granskas internt avseende kriterier för forskares kvalifikationer och legitimitet av forskningsförslaget.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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