A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
11. august 2014 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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London, Ontario, Canada
- Research Site
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California
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Long Beach, California, Forenede Stater
- Research Site
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San Leandro, California, Forenede Stater
- Research Site
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Florida
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Ft. Lauderdale, Florida, Forenede Stater
- Research Site
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Ocala, Florida, Forenede Stater
- Research Site
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Georgia
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Atlanta, Georgia, Forenede Stater
- Research Site
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Michigan
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Lansing, Michigan, Forenede Stater
- Research Site
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New York
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New York, New York, Forenede Stater
- Research Site
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater
- Research Site
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Ohio
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Columbus, Ohio, Forenede Stater
- Research Site
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Chihuahua, Mexico
- Research Site
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Guadalajara, Mexico
- Research Site
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Mexico, Mexico
- Research Site
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Lima, Peru
- Research Site
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Trujillo, Peru
- Research Site
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Cape Town, Sydafrika
- Research Site
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Johannesburg, Sydafrika
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
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A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
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Eksperimentel: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
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A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
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Eksperimentel: MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
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A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
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Eksperimentel: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
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A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
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Eksperimentel: MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
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A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsramme: Day 1 to Day 169
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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.
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Day 1 to Day 169
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pharmacokinetic Parameters for MEDI-570
Tidsramme: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
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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.
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Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
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Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Tidsramme: Predose on Day 1; Day 85, 113, and 169
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Predose on Day 1; Day 85, 113, and 169
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: David Close, PhD, MedImmune Ltd
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2010
Primær færdiggørelse (Faktiske)
1. juli 2012
Studieafslutning (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først indsendt
14. april 2010
Først indsendt, der opfyldte QC-kriterier
19. maj 2010
Først opslået (Skøn)
20. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-CP209
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