IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Cutaneous Lupus Erythematosus
Interventions
DRUG

IVIg

All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in \<25% subjects, the subjects will be re-treated by the standard protocol.

Trial Locations (2)

92697

The Institute for Clinical and Translational Science (ICTS), Irvine

Unversity of California, Irvine Healthcare, Dermatology, Gottschalk Medical Plaza, Irvine

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grifols Therapeutics LLC

INDUSTRY

lead

University of California, Irvine

OTHER