NCT01845740

Phase Ib Study of SC Milatuzumab in SLE

A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Milatuzumab or placebo will be given subcutaneously once weekly 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.

Conditions

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic
• Lupus Vasculitis, Central Nervous System
• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	milatuzumab	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.
DRUG	Placebo	Placebo will be administered subcutaneously once weekly for 4 weeks.

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2013-05-03
• Last updated: 2021-08-19

Locations

1 site across 1 country: United States