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

NCT00708916 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 07-580
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Discoid Lupus Erythematosus

Keywords

Cutaneous lupus; Intervention; Discoid lupus; Phosphodiesterase 5 inhibitor

Outcome Measures

Primary Outcomes (1)

• Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms

  To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x: The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Each score is reported separately. Outcome measures are reported for each time point for each subject due to the low numbers of enrollment.

  16 Weeks

Secondary Outcomes (5)

• Dermatology Quality of Life Index (DQLI)

  16 Weeks

• Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

  Weeks 1, 2, 4, 6, 8, 10, 12, 16

• Dermal and Circulating Blood Plasmacytoid Dendritic Cell Levels

  Weeks 0, 4 (dermal and circulating); week 12 (circulating only)

• Dermal and Circulating Blood T Regulatory Cell Levels

  Weeks 0, 4 (dermal and blood); Week 12 (blood only)

• Plasma Cytokine Levels

  Weeks 0, 4, 12

Study Arms (1)

Apremilast

EXPERIMENTAL

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

Drug: CC-10004

Interventions

CC-10004 DRUG

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

Also known as: Apremilast

Apremilast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cutaneous discoid lupus by clinical and histopathological exam

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Celgene Corporation: collaborator

Study Sites (1)

New York University Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

apremilast

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Andrew Franks, MD, Principal Investigator
• Organization: New York University School of Medicine

andrew.franks@nyumc.org

212-263-5244

Study Officials

• Andrew G Franks, Jr., MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)