Safety and Efficacy of CC-10004 for Prurigo Nodularis

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will include:

• Study period up to 7 months.

• Office visits monthly lasting approximately 1 hour.

• Blood Draws.

• Oral medication that is taken 2 times daily.

• Photographs and biopsies if agreed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Celgene Corporation
• Treatments: Apremilast; Thalidomide

Criteria

Inclusion Criteria:

• Must understand and voluntarily sign an informed consent form

• Must be male or female and aged ≥ 18 years at time of consent

• Must be able to adhere to the study visit schedule and other protocol requirements

• Must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin D derivatives.

• Must meet the following laboratory criteria:

• Hemoglobin WNL

• Hematocrit WNL

• White blood cell (WBC) count WNL

• Neutrophils ≥ 1500 /dL

• Platelets ≥ 100,000 /dL

• Serum creatinine ≤ 1.5 mg/dL

• Total bilirubin 2.0 mg/dL

• Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) 1.5x upper limit of normal (ULN)

• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.

• Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.

Exclusion Criteria:

• History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator

• Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration.

• Any topical treatments (including corticosteroids, vitamin D derivatives) within 14 days of study drug initiation.

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

• Pregnant or lactating female.