An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study Overview
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Brief Summary
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Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with CP/CPPS.

Detailed Description
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Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. Unlike bacterial prostatitis, where a clear infecting organism can be determined, CP/CPPS is not always treated with antibiotics. Due to the significant inflammatory nature of CP/CPPS, most prior therapies have focused on targeting the inflammation. CC-10004 in several studies has shown to be an inhibitor of inflammatory mediators, and may decrease the pain experienced from CP/CPPS.

Official Title
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An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Conditions
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Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Drug: CC-10004


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be male aged ≥ 18 years at time of consent Must understand and voluntarily sign an informed consent form Male subjects with at least 3 months of symptoms of CP/CPPS (pain in the pelvic area, penis, scrotum, or perineum) who are refractory to other therapies (e.g. NSAIDS) Must be able to adhere to the study visit schedule and other protocol requirements Diagnosis of Chronic Prostatitis with a Chronic Prostatitis Symptom Index of at least 15/24 Must meet the following laboratory criteria: Hemoglobin > 9 g/dL Hematocrit ≥ 27% White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and < 20,000/mL (< 20 X 109/L) Platelets ≥ 100,000 /mL (≥ 100 X 109/L) Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L) 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) Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with female capable of becoming pregnant while on study medication and for 28 days after taking the last dose of study medication Exclusion Criteria: Subjects who are female. Subjects with a documented positive urine culture within the past three months Subjects with duration of symptoms less than three months Subjects with genital infections within the past three months Subjects with clinical epididymitis within the past three months Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate Subjects having received prior radiation to the abdominal or pelvic area Subjects with known bladder or ureteral calculi Subjects unable to complete a voiding diary Subjects with neutropenia (ANC < 750/ mm3) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated. Positive Tuberculin skin test (Mantoux test) Clinically significant abnormality on the chest x-ray (CXR) at screening Any clinically significant abnormality on 12-lead ECG at screening Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer) History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas) Subjects currently taking chemotherapeutic agents Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening. Subjects with known history of significant disease as determined by the PI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Study Drug CC-10004<br>Study drug CC-10004 20mg taken orally twice a day. | Drug: CC-10004<br>* CC-10004 20 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response Assessment | The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatitis, Pelvic pain