Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY2)

20. november 2020 oppdatert av: UCB Pharma

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

791

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Brasil
      • Belo Horizonte, Brasil
        • 954
      • Campinas, Brasil
        • 956
      • Goiânia, Brasil
        • 955
      • Juiz de Fora, Brasil
        • 950
      • Rio de Janeiro, Brasil
        • 952
  • Canada
      • Hamilton, Canada
        • 502
      • London, Canada
        • 500
      • Toronto, Canada
        • 504
      • Victoria, Canada
        • 517
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 506
    • Ontario
      • Mississauga, Ontario, Canada
        • 507
    • Quebec
      • Rimouski, Quebec, Canada
        • 508
  • Den russiske føderasjonen
      • Kemerovo, Den russiske føderasjonen
        • 778
      • Kemerovo, Den russiske føderasjonen
        • 780
      • Moscow, Den russiske føderasjonen
        • 779
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
        • 539
    • Arkansas
      • Little Rock, Arkansas, Forente stater
        • 557
    • California
      • Hemet, California, Forente stater
        • 515
      • Huntington Beach, California, Forente stater
        • 544
      • La Jolla, California, Forente stater
        • 550
      • Los Angeles, California, Forente stater
        • 548
      • San Diego, California, Forente stater
        • 589
      • San Leandro, California, Forente stater
        • 531
      • Torrance, California, Forente stater
        • 558
      • Westlake Village, California, Forente stater
        • 594
    • Colorado
      • Denver, Colorado, Forente stater
        • 532
    • Connecticut
      • Bridgeport, Connecticut, Forente stater
        • 511
    • Florida
      • Brandon, Florida, Forente stater
        • 514
      • Fort Lauderdale, Florida, Forente stater
        • 533
      • Plantation, Florida, Forente stater
        • 518
      • Port Orange, Florida, Forente stater
        • 585
      • Tampa, Florida, Forente stater
        • 538
    • Georgia
      • Atlanta, Georgia, Forente stater
        • 537
      • Decatur, Georgia, Forente stater
        • 587
    • Idaho
      • Idaho Falls, Idaho, Forente stater
        • 590
    • Kentucky
      • Bowling Green, Kentucky, Forente stater
        • 543
      • Lexington, Kentucky, Forente stater
        • 592
    • Louisiana
      • New Orleans, Louisiana, Forente stater
        • 576
    • Massachusetts
      • Boston, Massachusetts, Forente stater
        • 572
    • Michigan
      • Ann Arbor, Michigan, Forente stater
        • 554
      • Lansing, Michigan, Forente stater
        • 513
      • Lansing, Michigan, Forente stater
        • 599
    • Missouri
      • Florissant, Missouri, Forente stater
        • 575
      • Saint Louis, Missouri, Forente stater
        • 549
    • New Hampshire
      • Nashua, New Hampshire, Forente stater
        • 596
    • New Jersey
      • Clifton, New Jersey, Forente stater
        • 593
      • Freehold, New Jersey, Forente stater
        • 568
    • New York
      • Brooklyn, New York, Forente stater
        • 551
      • Lake Success, New York, Forente stater
        • 553
      • Manhasset, New York, Forente stater
        • 545
      • Roslyn, New York, Forente stater
        • 577
    • North Carolina
      • Charlotte, North Carolina, Forente stater
        • 559
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater
        • 547
    • Pennsylvania
      • Wyomissing, Pennsylvania, Forente stater
        • 561
    • South Carolina
      • Charleston, South Carolina, Forente stater
        • 535
      • Myrtle Beach, South Carolina, Forente stater
        • 598
    • Tennessee
      • Jackson, Tennessee, Forente stater
        • 571
    • Texas
      • Amarillo, Texas, Forente stater
        • 574
      • Austin, Texas, Forente stater
        • 570
      • Houston, Texas, Forente stater
        • 541
      • Houston, Texas, Forente stater
        • 563
      • San Antonio, Texas, Forente stater
        • 562
    • Virginia
      • Chesapeake, Virginia, Forente stater
        • 552
    • Washington
      • Seattle, Washington, Forente stater
        • 534
  • Frankrike
      • Caen, Frankrike
        • 613
      • Limoges Cedex, Frankrike
        • 618
      • Montpellier Cedex 5, Frankrike
        • 617
      • Paris, Frankrike
        • 614
      • Toulouse Cedex 9, Frankrike
        • 616
  • India
      • Ahmedabad, India
        • 852
      • Bangalore, India
        • 853
  • Italia
      • Milano, Italia
        • 648
      • Pisa, Italia
        • 647
      • Roma, Italia
        • 646
  • Mexico
      • Cuauhtémoc, Mexico
        • 978
      • Mexico, Mexico
        • 982
      • Mexico City, Mexico
        • 976
      • Torreon, Mexico
        • 981
  • Polen
      • Bydgoszcz, Polen
        • 743
      • Czestochowa, Polen
        • 744
      • Elblag, Polen
        • 752
      • Katowice, Polen
        • 745
      • Katowice, Polen
        • 746
      • Lublin, Polen
        • 748
      • Lublin, Polen
        • 750
      • Poznan, Polen
        • 742
      • Szczecin, Polen
        • 747
      • Ustron, Polen
        • 751
      • Warsaw, Polen
        • 749
  • Romania
      • Bucharest, Romania
        • 757
      • Bucharest, Romania
        • 758
      • Bucharest, Romania
        • 760
      • Constanta, Romania
        • 759
      • Galati, Romania
        • 756
      • Iasi, Romania
        • 761
  • Spania
      • Barcelona, Spania
        • 661
      • Getafe, Spania
        • 660
      • Las Palmas de Gran Canaria, Spania
        • 662
      • Madrid, Spania
        • 664
      • Santiago de Compostela, Spania
        • 663
      • Vigo, Spania
        • 659
  • Storbritannia
      • Birmingham, Storbritannia
        • 677
      • Christchurch, Storbritannia
        • 678
      • London, Storbritannia
        • 679
  • Sør-Afrika
      • Cape Town, Sør-Afrika
        • 901
      • Durban, Sør-Afrika
        • 902
      • Stellenbosch, Sør-Afrika
        • 903
  • Tyskland
      • Berlin, Tyskland
        • 628
      • Berlin, Tyskland
        • 633
      • Dessau, Tyskland
        • 636
      • Hamburg, Tyskland
        • 637
      • Herne, Tyskland
        • 632
      • Kiel, Tyskland
        • 629
      • Köln, Tyskland
        • 625
      • Leipzig, Tyskland
        • 626
      • Mainz, Tyskland
        • 634
      • Münster, Tyskland
        • 627
      • Wiesbaden, Tyskland
        • 639
      • Zerbst, Tyskland
        • 631
  • Ukraina
      • Donetsk, Ukraina
        • 791
      • Kiev, Ukraina
        • 790
      • Kiev, Ukraina
        • 794
      • Kiev, Ukraina
        • 797
      • Luhansk, Ukraina
        • 792
      • Odessa, Ukraina
        • 793
      • Vinnytsya, Ukraina
        • 796
  • Ungarn
      • Budapest, Ungarn
        • 712
      • Budapest, Ungarn
        • 716
      • Budapest, Ungarn
        • 718
      • Debrecen, Ungarn
        • 717
      • Szeged, Ungarn
        • 711
      • Szeged, Ungarn
        • 715
      • Zalaegerszeg, Ungarn
        • 713

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:

  • Positive antinuclear antibodies (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
  • Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
  • On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

  • Subjects who are breastfeeding, pregnant, or plan to become pregnant
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
  • Subjects with the evidence of an immunosuppressive state
  • Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
  • History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
  • Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
  • Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
  • Subjects with substance abuse or dependence or other relevant concurrent medical condition
  • Subjects with history of thromboembolic events within 1 year of screening Visit.
  • Subjects with significant hematologic abnormalities
  • Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
  • Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
  • Subject has previously participated in this study or has previously received epratuzumab treatment.

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: Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Legemiddel: Placebo
Placebo-infusjoner gitt ukentlig i 4 uker over fire 12-ukers behandlingssykluser
Eksperimentell: Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Legemiddel: Epratuzumab
600 mg infusjoner gitt ukentlig i totalt 4 uker (kumulativ dose 2400 mg) over fire 12-ukers behandlingssykluser
Legemiddel: Epratuzumab
1200 mg infusjoner gitt annenhver uke i totalt 4 uker (kumulativ dose 2400 mg) over fire 12-ukers behandlingssykluser
Eksperimentell: Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Legemiddel: Placebo
Placebo-infusjoner gitt ukentlig i 4 uker over fire 12-ukers behandlingssykluser
Legemiddel: Epratuzumab
600 mg infusjoner gitt ukentlig i totalt 4 uker (kumulativ dose 2400 mg) over fire 12-ukers behandlingssykluser
Legemiddel: Epratuzumab
1200 mg infusjoner gitt annenhver uke i totalt 4 uker (kumulativ dose 2400 mg) over fire 12-ukers behandlingssykluser

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Tidsramme: At Week 48
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 48

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Tidsramme: At Week 24
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Tidsramme: At Week 12
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Tidsramme: At Week 36
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
Tidsramme: At Week 24
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
Tidsramme: At Week 48
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
At Week 48

Samarbeidspartnere og etterforskere

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

Sponsor

UCB Pharma

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

1. desember 2010

Primær fullføring (Faktiske)

1. mai 2015

Studiet fullført (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først innsendt

14. desember 2010

Først innsendt som oppfylte QC-kriteriene

15. desember 2010

Først lagt ut (Anslag)

16. desember 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SL0010
  • 2010-018565-26 (EudraCT-nummer)

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. .

Kliniske studier på Systemisk lupus erythematosus

Kliniske studier på Placebo

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Tanzania

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere