Phase Ib Study of SC Milatuzumab in SLE
Milatuzumab will be given subcutaneously at different dose levels once or twice weekly (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Lupus Vasculitis, Central Nervous System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)|
- safety [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]Safety of the subcutaneously administered milatuzumab will be assessed using laboratory and clinical data comparing baseline lab results and clinical condition to the lab results and clinical condition/adverse events during treatment and follow-up timepoints up to 2 years.
- Efficacy [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Efficacy will be assessed using the BILAG scoring model for lupus disease activity and symptoms by comparing baseline BILAG measurements against the BILAG measurements obtained during treatment and during follow-up for up to 2 years.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Milatuzumab SC
Milatuzumab is the study drug that will be administered subcutaneously at 3 different dose levels once or twice weekly for 4 weeks.
Milatuzumab has been used in clinical trials for multiple myeloma, non-Hodgkin's lymphoma and leukemia in the intravenous dosing form. In this study, milatuzumab is being given subcutaneously in patients with lupus.
Other Name: Milatuzumab is a Cd74 targeted humanized monoclonal antibody.
Milatuzumab will be given subcutaneously at different dose levels once or twice weekly (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE). The treatment portion of the study lasts 4 weeks. Then patients are followed for disease activity for at least 12 weeks. If patients respond to the study drug, they may be eligible for one course of retreatment, again followed by 12 weeks of follow-up. Patients who showed a response will continue to be followed at timepoints up to one year after treatment to assess how long the response lasts.
|Contact: Heather Horne||973-605-8200 ext firstname.lastname@example.org|
|Contact: Fran Bozza||973-605-8200 ext email@example.com|
|United States, California|
|Cedars Sinai Medical Center-Wallace Rheumatic Study Center||Not yet recruiting|
|West Hollywood, California, United States, 90048|
|Principal Investigator:||William Wegener, PhD, MD||Immunomedics, Inc.|