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

This study has been terminated.
(Business reasons)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01127321
First received: April 14, 2010
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Lupus Erythematosus, Systemic
Other: Placebo
Biological: MEDI-570 0.03 MG
Biological: MEDI-570 0.1 MG
Biological: MEDI-570 0.3 MG
Biological: MEDI-570 1 MG
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Predose on Day 1; Day 85, 113, and 169 ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Other: Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Experimental: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Biological: MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
Experimental: MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Biological: MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Experimental: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Biological: MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Experimental: MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Biological: MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127321

Locations
United States, California
Research Site
Long Beach, California, United States
Research Site
San Leandro, California, United States
United States, Florida
Research Site
Ft. Lauderdale, Florida, United States
Research Site
Ocala, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Michigan
Research Site
Lansing, Michigan, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
Canada, Ontario
Research Site
London, Ontario, Canada
Mexico
Research Site
Chihuahua, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico, Mexico
Peru
Research Site
Lima, Peru
Research Site
Trujillo, Peru
South Africa
Research Site
Cape Town, South Africa
Research Site
Johannesburg, South Africa
Sponsors and Collaborators
MedImmune LLC
AstraZeneca
Investigators
Study Director: David Close, PhD MedImmune Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01127321     History of Changes
Other Study ID Numbers: MI-CP209
Study First Received: April 14, 2010
Results First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Systemic lupus erythematosus
SLE
MEDI-570

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 20, 2014