Safety and Efficacy of CC-10004 for Prurigo Nodularis

Last updated: September 27, 2016
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Completed

Phase

2

Condition

Eczema (Atopic Dermatitis - Pediatric)

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Treatment

N/A

Clinical Study ID

NCT00869089
102652
12-07-24
  • Ages > 18
  • All Genders

Study 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

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 findingsand have failed four weeks of treatment with topical therapies, includingcorticosteroids 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]) andalanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) 1.5xupper limit of normal (ULN)

  • Females of childbearing potential (FCBP) must have a negative urine pregnancy test atscreening (Visit Must have a negative purified protein derivative (PPD) within 28 daysof the baseline visit.

  • Must have a negative purified protein derivative (PPD) within 28 days of the baselinevisit.

Exclusion

Exclusion Criteria:

  • History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,renal, hematologic, immunologic, or other major diseases deemed clinically significantby 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 14days of study drug initiation.

  • Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.

  • Pregnant or lactating female.

Study Design

Total Participants: 5
Study Start date:
September 01, 2008
Estimated Completion Date:
January 31, 2011

Connect with a study center

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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