| Eligibility |
Inclusion Criteria
1. Male and female subjects between 18 and 70 years of age
2. Oral ulcers that occurred at least monthly in the 6 month period prior to enrollment
3. Had at least 2 oral ulcers in the 4 weeks prior to enrollment at baseline
4. At least 3 oral ulcers during an ulcer flare
5. Patients must be candidates for systemic therapy for the treatment of oral ulcers,
those that are considered unsuitable for topical therapy alone based on severity of
disease, or whose oral ulcers cannot be adequately controlled with topical therapy.
6. Female premenopausal subjects must use one of the approved contraceptive options while
taking apremilast and for at least 28 days after administration of the last dose of
apremilast
7. Patients are able and willing to provide written informed consent after the nature of
the study is fully explained.
8. No evidence of systemic disease
Exclusion Criteria
1. Prior use of apremilast.
2. Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
3. Having received concomitant immune modulating therapy 12 weeks prior to enrollment,
systemic steroids 6 weeks prior to enrollment or topical steroids within 4 weeks prior
to enrollment.
4. Pregnant women or breast-feeding mothers.
5. Systemic or opportunistic fungal infection.
6. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
or other infections (tuberculosis and atypical mycobacterial disease, hepatitis B and
C and herpes zoster, histoplasmosis, coccidiomycosis) or any major episode of
infection requiring hospitalization or treatment with IV or oral antibiotics within 4
weeks of the screening phase.
7. History of positive test for, or any clinical suspicion of, human immunodeficiency
virus (HIV), or congenital or acquired immunodeficiency.
8. History of depression.
9. Malignancy or history of malignancy, except for:
a - treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; b -
treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of
cervix with no evidence of recurrence within the previous 5 years.
10. 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.
11. 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.
12. 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.
13. Active substance abuse or a history of substance abuse within 6 months prior to
screening.
14. Presence of any of the following vitamin deficiencies - B1, B2, B6, B12, vitamin C,
zinc, folate, iron.
15. Celiac disease.
16. Inflammatory Bowel Disease.
17. Genital aphthous ulcers.
18. Behçet's disease.
19. History of positive patch test for allergic contact stomatitis.
20. Positive anti-endomysial or anti-gliadin antibodies.
21. A diagnosis of uveitis (current or previous).
22. Erythema nodosum-like lesions (current or previous).
23. An established diagnosis of a systemic disease (SLE, Reiter's, Sweet's and MAGIC
syndrome).
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