NCT01127321

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2010

Typical duration for phase_1

Geographic Reach
5 countries

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

April 14, 2010

Results QC Date

August 11, 2014

Last Update Submit

August 11, 2014

Conditions

Lupus Erythematosus, Systemic

Keywords

Systemic lupus erythematosusSLEMEDI-570

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1 to Day 169

Secondary Outcomes (2)

  • Pharmacokinetic Parameters for MEDI-570

    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

    Predose on Day 1; Day 85, 113, and 169

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

MEDI-570 0.03 MG

EXPERIMENTAL

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

Biological: MEDI-570 0.03 MG

MEDI-570 0.1 MG

EXPERIMENTAL

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

Biological: MEDI-570 0.1 MG

MEDI-570 0.3 MG

EXPERIMENTAL

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

Biological: MEDI-570 0.3 MG

MEDI-570 1 MG

EXPERIMENTAL

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

Biological: MEDI-570 1 MG

Interventions

PlaceboOTHER

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

Placebo
MEDI-570 0.03 MGBIOLOGICAL

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

MEDI-570 0.03 MG
MEDI-570 0.1 MGBIOLOGICAL

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

MEDI-570 0.1 MG
MEDI-570 0.3 MGBIOLOGICAL

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

MEDI-570 0.3 MG
MEDI-570 1 MGBIOLOGICAL

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

MEDI-570 1 MG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

Long Beach, California, United States

Location

Research Site

San Leandro, California, United States

Location

Research Site

Fort Lauderdale, Florida, United States

Location

Research Site

Ocala, Florida, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Lansing, Michigan, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Columbus, Ohio, United States

Location

Research Site

London, Ontario, Canada

Location

Research Site

Chihuahua City, Mexico

Location

Research Site

Guadalajara, Mexico

Location

Research Site

México, Mexico

Location

Research Site

Lima, Peru

Location

Research Site

Trujillo, Peru

Location

Research Site

Cape Town, South Africa

Location

Research Site

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

MEDI-570

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

The study was terminated early by the sponsor due to business reasons.

Results Point of Contact

Title
David Close, Director, Clinical Development
Organization
MedImmune, LLC.
closeda@medimmune.com
301-398-0000

Study Officials

  • David Close, PhD

    MedImmune Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

May 20, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 26, 2014

Results First Posted

August 26, 2014

Record last verified: 2014-08

Locations

ZA(2)US(9)PE(2)CA(1)ME(3)