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Phase Ib Study of SC Milatuzumab in SLE

NCT01845740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-08-19

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • William Wegener, PhD, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845740 on ClinicalTrials.gov