Safety and Efficacy of CC-10004 for Prurigo Nodularis (NCT00869089) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of CC-10004 for Prurigo Nodularis
United States5 participantsStarted 2008-09
Plain-language 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 if agreed.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) with…
What they're measuring
1
Improvement in Prurigo Nodularis
Timeframe: 24 weeks
Trial details
NCT IDNCT00869089
SponsorUniversity Hospitals Cleveland Medical Center