NCT00657189
Completed
Phase 2
A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus
Overview
- Phase
- Phase 2
- Intervention
- MEDI-545
- Conditions
- Lupus Erythematosus, Systemic
- Sponsor
- MedImmune LLC
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects ≥ 18 years at the time of the first dose of study drug;
- •Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
- •Meet at least 4 of the 11 revised ACR classification criteria for SLE
- •Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
- •Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
- •Treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or dapsone;
- •Women, unless surgically sterile or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from screening through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) from Study Day 0 through the end of the study;
- •Ability to complete the study period, including the follow-up period through Study Day 168; and
- •Willing to forego other forms of experimental treatment during the study.
Exclusion Criteria
- •Have received MEDI-545 within 120 days prior to screening;
- •History of allergy or reaction to any component of the study drug formulation;
- •Have received the following medications within 28 days before randomization:
- •Systemic cyclophosphamide at any dose
- •Cyclosporine at any dose
- •Thalidomide at any dose
- •Hydroxychloroquine \> 600 mg/day
- •Mycophenolate mofetil \> 3 g/day
- •Methotrexate \> 25 mg/week
- •Azathioprine \> 3 mg/kg/day
Arms & Interventions
1
MEDI-545
Intervention: MEDI-545
2
MEDI-545
Intervention: MEDI-545
3
MEDI-545
Intervention: MEDI-545
4
MEDI-545
Intervention: MEDI-545
5
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
Time Frame: Immediately following the first administration of study drug through Study Day 168.
Secondary Outcomes
- A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545.(At Study Day 98)
Study Sites (1)
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