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Safety and Efficacy of CC-10004 for Prurigo Nodularis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869089
First Posted: March 25, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center
  Purpose

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: None (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 Neil Korman, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869089


Locations
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Celgene Corporation
Investigators
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
ClinicalTrials.gov Identifier: NCT00869089     History of Changes
Other Study ID Numbers: 102652
12-07-24 ( Other Identifier: Institutional Review Board (IRB) Number )
First Submitted: March 23, 2009
First Posted: March 25, 2009
Results First Submitted: May 20, 2014
Results First Posted: June 20, 2014
Last Update Posted: November 2, 2016
Last Verified: September 2016

Keywords provided by Neil Korman, University Hospitals Cleveland Medical Center:
PN

Additional relevant MeSH terms:
Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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