Prurigo Nodularis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospital Case Medical Center | Celgene Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Prurigo Nodularis | 24 weeks | No |
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