Early Phase 1
N=16
IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01841619 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS) — 100; 94; 84; 94 Percent of Baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- IVIg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS) |
100; 94; 84; 94; 86; 85 | — |
| PRIMARY Skindex 29 |
100; 97; 94; 92; 90; 81 | — |
| SECONDARY Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI) |
100; 100; 100; 136; 104; 105 | — |
| SECONDARY Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS) |
100; 100; 98; 100; 97; 92 | — |
| SECONDARY Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS) |
100; 100; 100; 100; 100; 100 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01841619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.