Safety and Efficacy of CC-10004 for Prurigo Nodularis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prurigo Nodularis

Intervention / Treatment
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* Drug: CC-10004


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-10004<br>CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY) | Drug: CC-10004<br>* 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)<br>* Other names: apremilast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Prurigo Nodularis |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PN