Safety and Efficacy of CC-10004 for Prurigo Nodularis

Prurigo Nodularis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869089
• Other study ID #: 102652
• Secondary ID: 12-07-24
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2009
• Last updated: June 20, 2014
• Start date: September 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Prurigo Nodularis		24 weeks	No