Prurigo Nodularis
Conditions
Keywords
PN
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.
Interventions
DRUGCC-10004
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Sponsors
Celgene Corporation
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Prurigo Nodularis | 24 weeks |
Countries
United States
Participant flow
Recruitment details
Enrollment was open from September 2008 through 2009. Study visits were conducted in outpatient Dermatology clinic.
Pre-assignment details
This was an open label single site study for adults with recalcitrant prurigo nodularis. Participants must have failed 4 weeks of treatment with topical corticosteroids or vitamin D derivatives.
Participants by arm
| Arm | Count |
|---|---|
| CC-10004 CC-10004 Treatment | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Screen Fail | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CC-10004 |
|---|---|
| Age, Customized Age < 18 | 0 participants |
| Age, Customized Age > or = 18 | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Improvement in Prurigo Nodularis
Time frame: 24 weeks
Population: Subjects who completed the study were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CC-10004 | Improvement in Prurigo Nodularis | Response to treatment | 0 participants |
| CC-10004 | Improvement in Prurigo Nodularis | Minimal or no response to treatment | 2 participants |