Safety and Efficacy of CC-10004 for Prurigo Nodularis

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Prurigo Nodularis

Treatments: Drug: CC-10004

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00869089

12-07-24 (Other Identifier)

102652

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

CC-10004

Experimental group

Description:

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

Treatment:

Drug: CC-10004