CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 16 enrolled
Drug / intervention
IVIgdrug
Likely dose
IVIg 500 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01841619
NCT01841619Early Ph 1Completed
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Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus

University of California, Irvine·interventional·Posted Apr 26, 2013·Updated Aug 10, 2015

In Brief

A Early Phase 1 clinical trial evaluating IVIg for Cutaneous Lupus Erythematosus. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Lupus Erythematosus
CountriesUnited States
CollaboratorsGrifols Therapeutics LLC

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.2 years ago

Interventions

IVIgdrug

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.