A Study of the Safety and Tolerability of MEDI-570 (Experimental Drug) in Systemic Lupus Erythematosus

This study has been terminated.
(Sponsor decision)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01127321
First received: April 14, 2010
Last updated: November 13, 2012
Last verified: November 2012
  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
SLE
Drug: MEDI-570
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 Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The safety and tolerability of MEDI-570 will be assessed. [ Time Frame: Study Day 169 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoints of the study are to assess the pharmacokinetics (PK) and immunogenicity (IM) of single fixed SC doses of MEDI-570 in adult subjects with moderately to severely active SLE. [ Time Frame: Study Day 169 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-570
Find maximum tolerated dose of MEDI-570 given subcutaneously. Escalating doses of MEDI-570 starting at 0.03 mg.
Drug: MEDI-570
Increase dose cohorts from 0.03 mg to maximum 10 mg.

Detailed Description:

To evaluate the safety and tolerability of escalating, single, subcutaneous (SC) doses of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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 SLE
  • Score ≥ 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 (IV 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, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, California
Research Site
LaJolla, California, United States, 92037
Research Site
Long Beach, California, United States, 90806
Research Site
San Leandro, California, United States, 94578
United States, Florida
Research Site
Fort Lauderdale, Florida, United States, 33334
Research Site
Ocala, Florida, United States, 34474
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30303
United States, Kansas
Research Site
Kansas City, Kansas, United States
United States, Michigan
Research Site
Lansing, Michigan, United States, 48910
United States, New York
Research Site
Brooklyn, New York, United States, 11203
Research Site
New York, New York, United States, 10021
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
Research Site
Columbus, Ohio, United States
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 4V2
Mexico
Research Site
Mexico, Distrito Federal, Mexico, 11850
Research Site
Mexico, Distrito Federal, Mexico, 6726
Research Site
Mexico, Distrito Federal, Mexico, 14050
Research Site
Mexico, Distrito Federal, Mexico, 10700
Research Site
Guadalajara, Jalisco, Mexico, 44620
Research Site
Morelia, Michoacan, Mexico, 58249
Research Site
Chihuahua, Mexico, 31000
South Africa
Research Site
Johannesburg, Gauteng, South Africa, 2192
Research Site
Cape Town, Western Cape, South Africa, 7925
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
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014