Phase 2
N=17
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01559090 ↗Enrolled (actual)
17
Serious AEs
41.2%
Results posted
Mar 2019
Primary outcome: Primary: Overall Summary of Adverse Events — 6; 5; 6; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI-546 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Summary of Adverse Events |
6; 5; 6; 1; 1; 1 | — |
| SECONDARY Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax |
41.1; 75.1; 254.8 | — |
| SECONDARY Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast |
221.5; 666.5; 3151.9 | — |
| SECONDARY Anti-drug Antibody (ADA) |
1; 1; 1; 5; 4; 5 | — |
Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
Eligibility Criteria
Inclusion Criteria
- Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
- Weight greater than or equal to 40.0 kg.
- Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
- Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
- Active moderate to severe SLE disease based on SLE disease activity score.
Exclusion Criteria
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease or unstable renal disease.
- Clinically significant active infection including ongoing and chronic infections.
- Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
- Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Data sourced from ClinicalTrials.gov (NCT01559090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.