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Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab (SUSTAIN)

25. september 2019 oppdatert av: Biogen

A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)

The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

41

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • Research Site
  • Forente stater
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Research Site
    • Iowa
      • Des Moines, Iowa, Forente stater, 50314
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53501
        • Research Site
  • Italia
      • Napoli, Italia, 80131
        • Research Site
    • Isernia
      • Pozzilli, Isernia, Italia, 86077
        • Research Site
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Research Site
  • Tyskland
      • Hamburg, Tyskland, 20249
        • Research Site
    • Bayern
      • Muenchen, Bayern, Tyskland, 81675
        • Research Site
    • Brandenburg
      • Potsdam, Brandenburg, Tyskland, 14471
        • Research Site
    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
        • Research Site

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 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria

  • Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman 2011].
  • Must have been treated with natalizumab for at least the 12 months prior to screening and have not missed 2 or more consecutive scheduled doses.
  • Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to enrollment.
  • Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive, at screening.
  • Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.

Key Exclusion Criteria

  • Current participation in another investigational study.
  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014].
  • Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
  • History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening.
  • History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient or any of the excipients.
  • History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
  • Discontinued natalizumab due to suspicion of PML.
  • Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  • The participant is using another MS therapy concomitantly.
  • Known history of human immunodeficiency virus (HIV).
  • Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
  • The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.

NOTE: Other protocol defined Inclusion/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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Daclizumab
Legemiddel: Daclizumab
High yield formulation
Andre navn:
  • Zinbryta
  • BIIB019

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Relapse-free at Month 6
Tidsramme: Month 6
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
Month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Relapse-free at Month 12
Tidsramme: Month 12
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Month 12
Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
Tidsramme: Month 12
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Month 12
Annualized Relapse Rate (ARR) at Month 12
Tidsramme: Month 12
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.
Month 12
Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
Tidsramme: Months 6 and 12
New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
Months 6 and 12
Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
Tidsramme: Months 6 and 12
New and newly enlarged T2 Hypointense Lesions were measured by MRI.
Months 6 and 12
Permanent Discontinuation Rate of Daclizumab at Month 12
Tidsramme: Month 12
Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.
Month 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: First dose of study drug to within 30 days of last dose (up to 11 months)
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.
First dose of study drug to within 30 days of last dose (up to 11 months)
Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
Tidsramme: First dose of study drug to within 30 days of last dose (up to 11 months)
Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
First dose of study drug to within 30 days of last dose (up to 11 months)

Samarbeidspartnere og etterforskere

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

Sponsor

Biogen

Samarbeidspartnere

AbbVie

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)

18. april 2017

Primær fullføring (Faktiske)

12. september 2018

Studiet fullført (Faktiske)

12. september 2018

Datoer for studieregistrering

Først innsendt

24. august 2016

Først innsendt som oppfylte QC-kriteriene

26. august 2016

Først lagt ut (Anslag)

29. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. september 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 205MS305
  • 2016-002820-10 (EudraCT-nummer)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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