Safety and Efficacy of CC-10004 for Prurigo Nodularis

NCT00869089 | Completed Phase 2 Results

• 2 other identifiers: 10265212-07-24
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Improvement in Prurigo Nodularis

  24 weeks

Study Arms (1)

CC-10004

EXPERIMENTAL

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

Drug: CC-10004

Interventions

CC-10004 DRUG

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

Also known as: apremilast

CC-10004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

apremilast

Results Point of Contact

• Title: Neil J. Korman, MD Principal Investigator
• Organization: University Hospitals Case Medical Center

neil.korman@UHHospitals.org

216-844-7164

Study Officials

• Neil Korman, M.D.,PhD.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 2, 2016
• Results First Posted: June 20, 2014

Record last verified: 2016-09

Locations

US (1)