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A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

11. august 2014 oppdatert av: MedImmune LLC

A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.

Studietype

Intervensjonell

Registrering (Faktiske)

44

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Research Site
  • Forente stater
    • California
      • Long Beach, California, Forente stater
        • Research Site
      • San Leandro, California, Forente stater
        • Research Site
    • Florida
      • Ft. Lauderdale, Florida, Forente stater
        • Research Site
      • Ocala, Florida, Forente stater
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Research Site
    • Michigan
      • Lansing, Michigan, Forente stater
        • Research Site
    • New York
      • New York, New York, Forente stater
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater
        • Research Site
    • Ohio
      • Columbus, Ohio, Forente stater
        • Research Site
  • Mexico
      • Chihuahua, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
      • Trujillo, Peru
        • Research Site
  • Sør-Afrika
      • Cape Town, Sør-Afrika
        • Research Site
      • Johannesburg, Sør-Afrika
        • 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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
  • Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
  • Ability to complete the study period, including follow-up period through Day 169
  • Willingness to forego other forms of experimental treatment during the study.

Exclusion Criteria:

  • History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
  • Evidence of active or latent tuberculosis (TB)
  • History of primary immunodeficiency
  • Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
  • History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
  • Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
  • Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
  • Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Annen: Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Eksperimentell: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Biologisk: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Eksperimentell: MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Biologisk: MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Eksperimentell: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Biologisk: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Eksperimentell: MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Biologisk: MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsramme: Day 1 to Day 169
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Day 1 to Day 169

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetic Parameters for MEDI-570
Tidsramme: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Tidsramme: Predose on Day 1; Day 85, 113, and 169
Predose on Day 1; Day 85, 113, and 169

Samarbeidspartnere og etterforskere

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

Sponsor

MedImmune LLC

Samarbeidspartnere

AstraZeneca

Etterforskere

  • Studieleder: David Close, PhD, MedImmune Ltd

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. mai 2010

Primær fullføring (Faktiske)

1. juli 2012

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

14. april 2010

Først innsendt som oppfylte QC-kriteriene

19. mai 2010

Først lagt ut (Anslag)

20. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2014

Sist bekreftet

1. august 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MI-CP209

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