A study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Study identifier:D2800C00001
ClinicalTrials.gov identifier:NCT01031836
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
Medical condition
Systemic Lupus Erythematosus
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI-545, MEDI-545 600
Sex
All
Actual Enrollment
30
Study type
Interventional
Age
20 Years - 130 Years
Date
Study Start Date: 25 Nov 2009
Primary Completion Date: 07 Nov 2012
Study Completion Date: 11 Jul 2016
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
MedImmune
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-545 1.0 mg/kg Cohort 1 | Drug: MEDI-545 Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
| Experimental: MEDI-545 3.0 mg/kg Cohort 2 | Drug: MEDI-545 Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses |
| Experimental: MEDI-545 10.0 mg/kg Cohort 3 | Drug: MEDI-545 Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
| Experimental: MEDI-545 100 mg Cohort 4 | Drug: MEDI-545 Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses. |
| Experimental: MEDI-545 600 mg Cohort 5 | Drug: MEDI-545 600 Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses. |
| Experimental: MEDI-545 1,200 mg Cohort 6 | Drug: MEDI-545 Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses |
Contacts
Investigators
Principal Investigator
Tsutomu Takeuchi
Department of Internal Medicine School of Medicine Keio University
