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Safety and Efficacy of CC-10004 for Prurigo Nodularis

This study has been completed.
Celgene Corporation
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center Identifier:
First received: March 23, 2009
Last updated: September 27, 2016
Last verified: September 2016

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.

Condition Intervention Phase
Prurigo Nodularis
Drug: CC-10004
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Improvement in Prurigo Nodularis [ Time Frame: 24 weeks ]

Enrollment: 5
Study Start Date: September 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-10004

CC-10004 treament:

30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Drug: CC-10004
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Other Name: apremilast


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00869089

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Celgene Corporation
Principal Investigator: Neil Korman, M.D.,PhD. University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Neil Korman, Principle Investigator, University Hospitals Cleveland Medical Center Identifier: NCT00869089     History of Changes
Other Study ID Numbers: 102652
12-07-24 ( Other Identifier: Institutional Review Board (IRB) Number )
Study First Received: March 23, 2009
Results First Received: May 20, 2014
Last Updated: September 27, 2016

Keywords provided by University Hospitals Cleveland Medical Center:

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 26, 2017