Eligibility Details:
Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to participate in this
study:
1. Must be 18 years or older at time of consent.
2. Patients must have clinically active OLP that is being considered for systemic
therapy; and an oral biopsy within the last 12 months of randomization showing a
lichenoid reaction correlating clinically with OLP.
3. Must have failed topical corticosteroids therapy. Topical corticosteroid failure is
defined as receiving a trial of at least 4 weeks of high potency topical
corticosteroids without achieving sufficient improvement by patients.
4. Must be in general good health (except for disease under study) as judged by the
Investigator, based on medical history, physical examination, clinical laboratories,
and urinalysis. (NOTE: The definition of good health means a subject does not have
uncontrolled significant co-morbid conditions). Laboratory work-up includes the
following: complete blood count (CBC), creatinine, albumin, aspartate aminotransferase
(AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin,
serum, Beta-HCG (if female), Hepatitis C antibodies and HgbA1C.
5. Male participants must use a recognized effective method of contraception with any
female partner (i.e. at a minimum, barrier plus an additional method of contraception)
while on investigational product and for at least 4 weeks after taking the last dose
of investigational product.
6. Female participants of childbearing potential (FCBP)†must have a negative pregnancy
test at Screening. While on investigational product and for at least 4 weeks after
taking the last dose of investigational product, FCBP who engage in activity in which
conception is possible must use one of the approved contraceptive§ options described
below:
1. Option 1: Any one of the following highly effective methods: hormonal
contraception (oral, injection, implant, transdermal patch, vaginal ring);
intrauterine device (IUD); tubal ligation; prior hysterectomy; prior bilateral
oophorectomy or salpingo-oophorectomy; or partner's vasectomy;
OR
2. Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of
natural [animal] membrane [for example, polyurethane]; plus one additional
barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide;
or (c) contraceptive sponge with spermicide.
- A female of childbearing potential is a sexually mature female who 1) has
not undergone a hysterectomy (the surgical removal of the uterus) or
bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not
been postmenopausal for at least 24 consecutive months (that is, has had
menses at any time during the preceding 24 consecutive months).
- The female subject's chosen form of contraception must be effective by the
time the female subject is randomized into the study (for example, hormonal
contraception should be initiated at least 28 days before randomization).
Exclusion Criteria:
All participants meeting any of the following exclusion criteria at baseline will be
excluded from participation in this study:
1. Inability to give written consent by the patient or alternative decision maker (will
be assessed at screening visit).
2. Unwillingness to use at least one effective method of contraception due to unknown
fetal risks
3. Use of systemic or topical therapy for OLP other than allowed concomitant care for
symptomatic relief in the past 4 weeks.
4. Hypersensitivity to Apremilast or use of Apremilast within 4 weeks prior to start of
study drug. The contraindications to Apremilast use include prior hypersensitivity
reactions, breast-feeding, and pregnancy (Uptodate.com® accessed August 1st, 2016). An
increased incidence of depression or depressed mood by 1.3% for Apremilast 30 mg BID
(twice a day) (OTEZLA® drug monograph accessed August 1st, 2016) was observed in phase
3 psoriasis studies. Celgene suggests that prescribers should carefully weigh the
risks and benefits in patients with a history of depression and/or suicidal thoughts
or behaviour. The research team will discuss these psychiatric adverse events in the
screening visit where patients/caregivers will be instructed to notify the treating
team for any mood changes.
5. History of palpitations/tachyarrhythmia, severe renal impairment (eGFR less than or
equal to 29), or lactose intolerance within the past 5 years. Apremilast pills contain
lactose; however, the use of concurrent lactase enzyme in lactose intolerant
participants will not be considered and lactose intolerant patients will still be
excluded even if they take lactase enzyme supplementation. This is explained by the
potential exacerbation of gastrointestinal symptoms with Apremilast as an Adverse
Event (AE).
6. CYP3A4 inducers have been shown to diminish Apremilast levels (Lexi-Comp Onlineâ„¢
Interaction Monograph accessed August 1st, 2015); hence, patients will be excluded if
they are on concomitant Carbamazepine, Enzalutamide, Fosphenytoin, Lumacaftor,
Mitotane, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, and Rifapentine.
7. As per Celgene, the presence of any of the following will exclude a subject from
enrollment:
1. Other than disease under study, any clinically significant (as determined by the
Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric,
hepatic, renal, hematologic, immunologic disease, or other major disease that is
currently uncontrolled.
2. Any condition, including the presence of laboratory abnormalities, which would
place the subject at unacceptable risk if he/she were to participate in the
study.
3. Prior history of suicide attempt at any time in the subject's life time prior to
screening or randomization, or major psychiatric illness requiring
hospitalization within the last 3 years.
4. Pregnant or breast feeding.
5. Active substance abuse or a history of substance abuse within 6 months prior to
Screening.
6. Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in
situ of cervix with no evidence of recurrence within the previous 5 years.
7. Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
8. Prior treatment with apremilast
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
