Clinical trial NCT00869089: Safety and Efficacy of CC-10004 for Prurigo Nodularis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prurigo Nodularis
Keywords: PN
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-03-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 if agreed.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Prurigo Nodularis
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Neil Korman, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: