At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
milatuzumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)
In Brief
A Phase 1 clinical trial evaluating milatuzumab and Placebo for Lupus Erythematosus, Cutaneous and 4 related conditions. Completed, enrolled 22 participants across 1 site.
Detailed Summary
Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic, Lupus Vasculitis, Central Nervous System, Lupus Nephritis
CountriesUnited States
CollaboratorsUnited States Department of Defense
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
Primary CompletionJun 2009
First PostedMay 2013
TodayJul 2026
First PostedMay 3, 2013
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.2 years ago
Interventions
milatuzumabdrug
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.
Placebodrug
Placebo will be administered subcutaneously once weekly for 4 weeks.