CC-10004 For The Treatment Of Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Intervention: CC-10004
Intervention description: CC-10004 20 mg. twice a day for 12 weeks
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: vulvodynia; pelvic pain; vulvar pain

Summary:

      Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or
      pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of
      these factors may include altered immune response, infections, altered vaginal acid-base
      balance, allergic reactions and psychosexual disorders. Women are generally treated with
      medications such as anti-histamines, anti-depressants and anti-inflammatories, or with
      physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents
      (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral
      medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided
      imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often
      ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is
      utilized as a last resort.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must understand and voluntarily sign and date the appropriate Informed
             Consent document.

          2. Female who is ≥ 18 years of age and <70 years of age.

          3. Participant must be able to adhere to the study visit schedule and other protocol
             requirements.

          4. Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3
             or greater on a 0-10 Likert scale.

          5. Subject -reported vulvar pain for at least 3 months prior to enrollment.

          6. Participant who is currently taking narcotics for pelvic pain must be on a stable
             regimen for 3 months prior to enrollment in the study.

          7. Females of childbearing potential (FCBP) must have a negative urine pregnancy test at
             screening/baseline (Visit 1). In addition, sexually active FCBP must agree to use TWO
             of the following adequate forms of contraception while on study medication: oral,
             injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine
             device; barrier contraceptive with spermicide; or vasectomized partner. A FCBP must
             agree to have pregnancy tests every 28 days while on study medication.

          8. Subject 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)

               -  Neutrophils ≥ 1500 /mL (≥ 1.5 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)

        Exclusion Criteria:

          1. Pregnant or lactating females

          2. History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic,
             psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major
             diseases

          3. 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

          4. 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.

          5. Positive TB skin test (Mantoux test)

          6. History of incompletely treated latent Mycobacterium tuberculosis infection as
             indicated by a positive positive Purified Protein Derivative [PPD] skin test or in
             vitro test [T-SPOT®. TB, QuantiFERON Gold®] or chest x-ray.

          7. Clinically significant abnormality on the chest x-ray (CXR) at screening.

          8. Use of any investigational medication within 28 days prior to randomization or 5
             half-lives if known (whichever is longer)

          9. Any clinically significant abnormality on 12-lead ECG at screening

         10. Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory
             test result indicating active infection at screening.

         11. 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)

         12. History of a vestibulectomy