Omalizumab for Lupus

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

January 8, 2014

Primary Completion Date

August 24, 2017

Study Completion Date

August 24, 2017

Conditions
Systemic Lupus ErthematosusSjogren's Syndrome
Interventions
DRUG

Omalizumab

For each subject, treatment with omalizumab will start with a loading dose of 600 mg followed by a maintenance dose of 300 mg every 4 weeks. The study drug will be administered as a subcutaneous injection. On Week 0 and Week 16 the medication or placebo will be administered to subjects via 4 subcutaneous injections; the remaining weeks 2 injections will be administered.Subjects will be given written directions on dealing with adverse reactions. They will also receive an Epi-Pen before discharge and instructions on how to use it.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

NCT01716312 - Omalizumab for Lupus | Biotech Hunter | Biotech Hunter