IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

University of California Irvine (UCI)

Status and phase: Completed; Early Phase 1

Conditions: Cutaneous Lupus Erythematosus

Treatments: Drug: IVIg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01841619

2013-9351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

IVIg as a monotherapy

Active Comparator group

Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

Treatment:

Drug: IVIg