NCT01841619

IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients.

Detailed description

The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies. From the review of literature, it can be postulated that: 1. the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks; 2. clinical improvement should last several weeks after the last infusion; and 3. remission may be prolonged by maintenance IVIg therapy. Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.

Conditions

• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-04-26
• Last updated: 2015-08-10
• Results posted: 2015-08-10

Locations

2 sites across 1 country: United States