Safety and Efficacy of CC-10004 for Prurigo Nodularis

Phase 2

Completed

• Conditions: Prurigo Nodularis
• Interventions: Drug: CC-10004

• Registration Number: NCT00869089
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-25
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2014-05-20
• Results First Submitted QC: 2014-05-20
• Results First Posted: 2014-06-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement in Prurigo Nodularis	24 weeks

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States