IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

NCT ID: NCT01841619

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVIg as a monotherapy

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

Group Type: ACTIVE_COMPARATOR

IVIg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Intravenous Immunoglobin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Sergei Grando

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergei Grando, MD PhD D.Sc.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

The Institute for Clinical and Translational Science (ICTS)

Irvine, California, United States

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

Irvine, California, United States

Countries

United States

Other Identifiers

2013-9351

Identifier Type: -

Identifier Source: org_study_id