Safety and tolerability of intravenous dose of MEDI-546 in Japanese subjects with Systemic Lupus Erythematosus.
Study identifier:D3461C00002
ClinicalTrials.gov identifier:NCT01559090
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE).
Medical condition
Systemic Lupus Erythematosus
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI-546
Sex
All
Actual Enrollment
17
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 20 Apr 2012
Primary Completion Date: 19 Aug 2014
Study Completion Date: 21 Feb 2017
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
MedImmune LLC
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 MEDI-546 100 mg IV | Drug: MEDI-546 Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| Experimental: 2 MEDI-546 300 mg IV | Drug: MEDI-546 Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| Experimental: 3 MEDI-546 1000 mg IV | Drug: MEDI-546 Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV. |
Contacts
Investigators
Principal Investigator
Roberta Weiss
MedImmune LLC
