Safety and Efficacy of CC-10004 for Prurigo Nodularis
Completed · Phase 2
Conditions studied: Prurigo Nodularis
In brief
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.
Key facts
- Study ID
- NCT00869089
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 5
- Starts
- 2008-09-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.