Safety and Efficacy of CC-10004 for Prurigo Nodularis

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

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.

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: CC-10004

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CC-10004; CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	Drug: CC-10004; 30mg,oral medication, BID, for 24 weeks (60mg total DAILY); Other Names: apremilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Prurigo Nodularis	24 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Celgene Corporation
• Investigators: Principal Investigator: Neil Korman, M.D.,PhD., University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (ESTIMATE): March 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: PN
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Prurigo; Neurodermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: 102652; 12-07-24 (OTHER: Institutional Review Board (IRB) Number)