An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Status: | Completed |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 68 |
Updated: | 8/22/2018 |
Start Date: | March 28, 2013 |
End Date: | July 18, 2018 |
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with
moderate to severe active systemic lupus erythematosus
moderate to severe active systemic lupus erythematosus
This is an open-label extension study to evaluate long-term safety and tolerability of
intravenous (IV) MEDI-546 in adult subjects with moderately-to-severely active systemic lupus
erythematosus (SLE). Subjects must have completed the qualifying Phase 2 study and meet this
study criteria in order to be eligible.
intravenous (IV) MEDI-546 in adult subjects with moderately-to-severely active systemic lupus
erythematosus (SLE). Subjects must have completed the qualifying Phase 2 study and meet this
study criteria in order to be eligible.
Inclusion Criteria:
- Must be willing to use 2 methods of effective contraception
- Must have venous access
- Must be willing to forego participation in other clinical trials for SLE.
Exclusion Criteria:
- Any concurrent condition that in the opinion of the investigator would interfere with
the evaluation of the investigational product
- Major surgery within 8 weeks before signing ICF
- Elective major surgery planned during the study period
- Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day,
Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, Oral, SC, or intramuscular
methotrexate > 25 mg/week
- A live or attenuated vaccine within 4 weeks of signing the ICF
- Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
We found this trial at
23
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