CC-10004 for Prurigo Nodularis



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2008
Contact:Kelly Jeffords, CCRC
Email:kelly.jeffords@uhhospitals.org
Phone:216-983-0861

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An Open Label, Single Center Study to Assess the Safety and Efficacy of a 24 Week Treatment Course of CC-10004 in Adults With Recalcitrant Nodularis

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.


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.
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