An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Condition: Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Intervention: CC-10004
Intervention description: CC-10004 20 mg per day
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostatitis; Pelvic pain

Summary:

      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.
    

Eligibility criteria:

        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