A Study of the Safety and Tolerability of MEDI-570 (Experimental Drug) in Systemic Lupus Erythematosus
This study has been terminated.
(Sponsor decision)
Sponsor:
MedImmune LLC
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
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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
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 May 21, 2013