Safety and Efficacy of CC-10004 for Prurigo Nodularis

NCT ID: NCT00869089

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-01-31

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.

Conditions

Prurigo Nodularis

Keywords

PN

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CC-10004

CC-10004 treament:

30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Group Type: EXPERIMENTAL

CC-10004

Intervention Type: DRUG

30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Interventions

CC-10004

30mg,oral medication, BID, for 24 weeks (60mg total DAILY)

Intervention Type: DRUG

Other Intervention Names

apremilast

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Neil Korman

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Korman, M.D.,PhD.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

12-07-24

Identifier Type: OTHER

Identifier Source: secondary_id

102652

Identifier Type: -

Identifier Source: org_study_id