IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborators: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

• Be at least 18 years of age at time of informed consent.

• Have had a diagnosis of CLE

• Currently has active CLE (any subtype) established by standard clinical and histo- and immunopathologic criteria

• Falls into one of the two following cohorts:

• Cohort 1 - Has received a standard systemic therapy without a therapeutic response for a minimum of one month

• Cohort 2 - Has not received any systemic treatment

Exclusion Criteria:

• Subject is not over 18 years of age.

• Subject cannot understand or follow directions.

• Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.

• Subject is pregnant, planning to get pregnant, or breast feeding.

• Subject has a known history of immunoglobulin A (IgA) deficiency.