Clinical trial: Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus (NCT01041625)

Eligibility criteria:
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

          -  Subjects must have stable cutaneous lichen planus appropriate for systemic therapy
             based on the following criteria:

               -  Rated PGA of ≥ 3 (moderate or severe) AND

               -  ≥ 20 distinct lesions of lichen planus OR

               -  Refractory to topical corticosteroid therapy (at least 4 weeks of high potency
                  corticosteroid without significant improvement) OR

               -  Severe itching/pain that significantly impairs activities of daily living (i.e.
                  working, school, sleep, etc.)

          -  Subjects using topical corticosteroids must be tapered and must undergo a washout
             period prior to initiation of the study. The washout period for topical
             corticosteroids is 2 weeks.

          -  Must meet the following laboratory criteria:

               -  Hemoglobin > 12 g/dL

               -  White blood cell (WBC) count ≥ 3000 /μL (≥ 3.0 X 109/L) and ≤ 14,000/μL (< 14 X
                  109/L)

               -  Platelets ≥ 100,000 /μL (≥ 100 X 109/L)

               -  Serum creatinine ≤ 1.5 mg/dL (or ≤ 133 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)

          -  Females of childbearing potential (FCBP) must have a negative urine pregnancy test at
             screening (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 while on study. A FCBP must
             agree to have pregnancy tests every 4 weeks while on study.

          -  Males (including those who have had a vasectomy) must agree to use barrier
             contraception (latex condoms) when engaging in sexual activity with FCBP while on
             study medication and for 84 days after taking the last dose of study medication

        Exclusion Criteria:

          -  Inability to provide voluntary consent

          -  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 breastfeeding

          -  Systemic fungal infection

          -  History of active mycobacterial infection with any species (including Mycobacterium
             tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium
             tuberculosis infection more than 3 years prior to screening visit are allowed if
             successful treatment was completed at least 3 years prior to randomization and is
             documented and available for verification.

          -  Latent Mycobacterium tuberculosis infection as indicated by a positive Purified
             Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and
             documented completion of treatment for latent TB are eligible. Subjects with a
             positive PPD skin test and not treated or no documentation of completion of treatment
             are ineligible.

          -  If QuantiFERON® test is performed instead of the PPD test, only those with a negative
             QuantiFERON® test are allowed in the study.

          -  History of incompletely treated Mycobacterium tuberculosis infection as indicated by

               -  Subject's medical records documenting incomplete treatment for Mycobacterium
                  tuberculosis

               -  Subject's self-reported history of incomplete treatment for Mycobacterium
                  tuberculosis

          -  History of recurrent bacterial infection (at least 3 major infections resulting in
             hospitalization and/or requiring intravenous antibiotic treatment within the past 2
             years)

          -  Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays
             performed within 3 months prior to start of study drug are acceptable.

          -  Use of topical cyclosporine, tacrolimus, or pimecrolimus within 2 weeks prior to start
             of study drug

          -  Use of systemic or intralesional corticosteroids, systemic retinoids, antimalarials,
             azathioprine, methotrexate, mycophenolate mofetil, dapsone, thalidomide,
             sulfasalazine, cyclosporine, metronidazole, griseofulvin, or phototherapy within 4
             weeks prior to start of study drug

          -  Use of etanercept within 8 weeks prior to start of study drug.

          -  Use of adalimumab or infliximab within 12 weeks prior to start of study drug

          -  Use of alefacept within 24 weeks prior to start of study drug.

          -  Use of any investigational medication within 4 weeks prior to start of study drug or 5
             pharmacokinetic/pharmacodynamic half-lives (whichever is longer)

          -  Any clinically significant abnormality on 12-lead ECG at screening

          -  History of congenital or acquired immunodeficiency (eg, Common Variable
             Immunodeficiency [CVID])

          -  Hepatitis B surface antigen positive or Hepatitis B core antibody positive at
             screening

          -  History of Human Immunodeficiency Virus (HIV) infection

          -  Antibodies to Hepatitis C at screening

          -  Positive ANA at screening visit

          -  Malignancy or history of malignancy (except for treated [ie, cured] basal- cell skin
             carcinomas > 3 years prior to screening)

          -  Presence of any other skin condition which may affect the evaluations of the study
             disease.

          -  Clinical picture suspicious for lichenoid drug eruption.

          -  Subjects whose lichen planus is predominantly hypertrophic, follicular, atrophic, or
             bullous variant.

          -  Lichen planus involving only mucosa or nails.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? 0