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

Primary Purpose

Lupus Erythematosus, Systemic

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Placebo
MEDI-570 0.03 MG
MEDI-570 0.1 MG
MEDI-570 0.3 MG
MEDI-570 1 MG
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Systemic lupus erythematosus, SLE, MEDI-570

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

MEDI-570 0.03 MG

MEDI-570 0.1 MG

MEDI-570 0.3 MG

MEDI-570 1 MG

Arm Description

A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.

A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.

A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.

A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.

A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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.

Secondary Outcome Measures

Pharmacokinetic Parameters for MEDI-570
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.
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit

Full Information

First Posted
April 14, 2010
Last Updated
August 11, 2014
Sponsor
MedImmune LLC
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01127321
Brief Title
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
Official Title
A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Systemic lupus erythematosus, SLE, MEDI-570

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Arm Title
MEDI-570 0.03 MG
Arm Type
Experimental
Arm Description
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Arm Title
MEDI-570 0.1 MG
Arm Type
Experimental
Arm Description
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Arm Title
MEDI-570 0.3 MG
Arm Type
Experimental
Arm Description
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Arm Title
MEDI-570 1 MG
Arm Type
Experimental
Arm Description
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
MEDI-570 0.03 MG
Intervention Description
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
MEDI-570 0.1 MG
Intervention Description
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
MEDI-570 0.3 MG
Intervention Description
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
MEDI-570 1 MG
Intervention Description
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
Day 1 to Day 169
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters for MEDI-570
Description
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.
Time Frame
Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Title
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Time Frame
Predose on Day 1; Day 85, 113, and 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Close, PhD
Organizational Affiliation
MedImmune Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
San Leandro
State/Province
California
Country
United States
Facility Name
Research Site
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Chihuahua
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Trujillo
Country
Peru
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa

12. IPD Sharing Statement

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

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