Phase 2
N=12
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
Discoid Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00708916 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Mar 2021
Primary outcome: Primary: Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-10004 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms |
— | — |
| SECONDARY Dermatology Quality of Life Index (DQLI) |
— | — |
| SECONDARY Common Terminology Criteria for Adverse Events v3.0 (CTCAE) |
— | — |
| SECONDARY Dermal and Circulating Blood Plasmacytoid Dendritic Cell Levels |
— | — |
| SECONDARY Dermal and Circulating Blood T Regulatory Cell Levels |
— | — |
| SECONDARY Plasma Cytokine Levels |
— | — |
Summary
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cutaneous discoid lupus by clinical and histopathological exam
Exclusion Criteria
- Systemic lupus involving the internal organs
- Systemic vasculitis
- History of other clinically significant disease process
- History of HIV, hepatitis B or C
- Concurrent use of immune modulating therapy
- Evidence of incompletely treated tuberculosis
- Pregnant or lactating female
Data sourced from ClinicalTrials.gov (NCT00708916). 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.