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Phosphodiesterase 4 (PDE-4) Inhibitor

Apremilast for Discoid Lupus

Phase 1 & 2
Waitlist Available
Led By Andrew G Franks, Jr., MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of cutaneous discoid lupus by clinical and histopathological exam
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 4, 6, 8, 10, 12, 16
Awards & highlights

Study 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.

Eligible Conditions
  • Discoid Lupus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 4, 6, 8, 10, 12, 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 4, 6, 8, 10, 12, 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms
Secondary outcome measures
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Plasmacytoid Dendritic Cells
Dermal and Circulating Blood T Regulatory Cell Levels
+2 more

Side effects data

From 2011 Phase 2 trial • 21 Patients • NCT00701311
18%
Nausea
12%
Diarrhea
12%
Headache
12%
Dizziness
6%
Lower extremity ulcer
6%
Mouth Ulcer
6%
Facial Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApremilastExperimental Treatment1 Intervention
CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
FDA approved

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,372 Previous Clinical Trials
841,102 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,228 Total Patients Enrolled
Andrew G Franks, Jr., MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
2008. "Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00708916.
~0 spots leftby May 2025
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