Status:
COMPLETED
Safety and Efficacy of CC-10004 for Prurigo Nodularis
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00869089
Start Date
September 1 2008
End Date
January 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106