IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

NCT01841619 | Completed Early Phase 1 Results DMC

• 1 other identifier: 2013-9351
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Cutaneous Lupus Erythematosus

Keywords

skin, lupus, intravenous immunoglobulin, ivig

Outcome Measures

Primary Outcomes (2)

• Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)

  Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.

  Initial, 1st Visit - 9th Visit

• Skindex 29

  The subjects also evaluated their skin-specific quality of life with the Skindex-29 - the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.

  Initial, 1st Visit - 9th Visit

Secondary Outcomes (3)

• Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)

  Initial, 1st Visit - 9th Visit

• Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)

  Initial, 1st Visit - 9th Visit

• Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)

  Initial, 1st Visit - 9th Visit

Study Arms (1)

IVIg as a monotherapy

ACTIVE COMPARATOR

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

Drug: IVIg

Interventions

IVIg 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.

Also known as: Intravenous Immunoglobin

IVIg as a monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Grifols Therapeutics LLC: collaborator

Study Sites (2)

The Institute for Clinical and Translational Science (ICTS)

Irvine, California, 92697, United States

Location

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

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sergei A. Grando
• Organization: UC Irvine Dermatology Research Center

sgrando@uci.edu

949 824 7103

Study Officials

• Sergei Grando, MD PhD D.Sc.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2013
• First Posted: April 26, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 10, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-03

Locations

US (2)