Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

NCT ID: NCT00708916

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-08-31

Brief 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.

Detailed Description

Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. However, side effects associated with these treatments are potentially problematic with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. This open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. To investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.

Conditions

Discoid Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apremilast

CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment

Group Type: EXPERIMENTAL

CC-10004

Intervention Type: DRUG

20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment

Interventions

CC-10004

20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment

Intervention Type: DRUG

Other Intervention Names

Apremilast

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew G Franks, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University Tisch Hospital

New York, New York, United States

Countries

United States

Study Documents

Document Type: Clinical Study Report

Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study. De Souza A, Strober BE, Merola JF, Oliver S, Franks AG Jr. J Drugs Dermatol. 2012 Oct;11(10):1224-6. PMID: 23134988

View Document

Other Identifiers

07-580

Identifier Type: -

Identifier Source: org_study_id