Safety and Efficacy of CC-10004 for Prurigo Nodularis | NCT00869089

Studies
Safety and Efficacy of CC-10004 for Prurigo Nodularis

NCT00869089

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

5Actual

Phase

Phase 2

Conditions

Prurigo Nodularis

Interventions

CC-10004

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12-07-24	Other Identifier	Institutional Review Board (IRB) Number

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 23, 2009

First Posted Date

Mar 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

May 20, 2014

Results First Submitted that Met QC Criteria

May 20, 2014

Results First Posted Date

Jun 20, 2014Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Name	Class
Celgene Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
CC-10004	Experimental	CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	Drug: CC-10004

Name	Type	Description	Arm Group Labels	Other Names
CC-10004	Drug	30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	CC-10004

Measure	Description	Time Frame
Improvement in Prurigo Nodularis		24 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Neil Korman, M.D.,PhD.	University Hospitals Cleveland Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Cleveland Medical Center		Cleveland	Ohio	44106	United States

ID	Title	Description
FG000	CC-10004	CC-10004 treatment: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Baseline Characteristics Module

Baseline Analysis Population Description

Number of subjects enrolled in the study.

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	CC-10004	CC-10004 Treatment

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Improvement in Prurigo Nodularis

Subjects who completed the study were analyzed.

Posted

Number

participants

24 weeks

ID	Title	Description
OG000	CC-10004	CC-10004 treatment

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CC-10004	CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Serious Adverse Events

Not provided

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders		Systematic Assessment