Phase 2
Completed N=12
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
Discoid Lupus Erythematosus
Source: ClinicalTrials.gov NCT00708916 ↗
Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Mar 2021
Primary outcomePrimary: Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms
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.
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 |
— | — |
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. Informational only — not medical advice.