Safety and Efficacy of CC-10004 for Prurigo Nodularis

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Neil Korman, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00869089
First received: March 23, 2009
Last updated: June 20, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
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 Hospital Case Medical Center:

Primary Outcome Measures:
  • Improvement in Prurigo Nodularis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869089

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

No publications provided

Responsible Party: Neil Korman, Principle Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00869089     History of Changes
Other Study ID Numbers: 102652, 12-07-24
Study First Received: March 23, 2009
Results First Received: May 20, 2014
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital Case Medical Center:
PN

Additional relevant MeSH terms:
Prurigo
Neurodermatitis
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014