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 |
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.
- 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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