Clinical trial NCT01841619: IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Official title: Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cutaneous Lupus Erythematosus
Keywords: skin, lupus, intravenous immunoglobulin, ivig
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Grifols Therapeutics LLC
First posted: 2013-04-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)
timeFrame: Initial, 1st Visit - 9th Visit
measure: Skindex 29
timeFrame: Initial, 1st Visit - 9th Visit
Secondary outcomes:
measure: Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)
timeFrame: Initial, 1st Visit - 9th Visit
measure: Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)
timeFrame: Initial, 1st Visit - 9th Visit
measure: Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)
timeFrame: Initial, 1st Visit - 9th Visit
Other outcomes:
Locations:
city: Irvine
country: United States
facility: The Institute for Clinical and Translational Science (ICTS)
state: California
city: Irvine
country: United States
facility: Unversity of California, Irvine Healthcare, Dermatology, Gottschalk Medical Plaza
state: California
Study officials:
affiliation: University of California, Irvine
name: Sergei Grando, MD PhD D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: