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Safety and Efficacy of CC-10004 for Prurigo Nodularis

Primary Purpose

Prurigo Nodularis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-10004
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo Nodularis focused on measuring PN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CC-10004

Arm Description

CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Outcomes

Primary Outcome Measures

Improvement in Prurigo Nodularis

Secondary Outcome Measures

Full Information

First Posted
March 23, 2009
Last Updated
September 27, 2016
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00869089
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis
Keywords
PN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-10004
Arm Type
Experimental
Arm Description
CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Intervention Type
Drug
Intervention Name(s)
CC-10004
Other Intervention Name(s)
apremilast
Intervention Description
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Primary Outcome Measure Information:
Title
Improvement in Prurigo Nodularis
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Korman, M.D.,PhD.
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of CC-10004 for Prurigo Nodularis

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