Brief Title
Apremilast for RAS
Official Title
A Pilot Study Evaluating the Efficacy of Apremilast in the Treatment of Subjects With Severe Recurrent Aphthous Stomatitis (RAS)
Brief Summary
Determination of treatment efficacy and safety of Apremilast in patients with RAS
Detailed Description
The study will be a pilot study using apremilast 30mg orally twice daily, for treatment of
RAS in males and females between 18 and 70 years old.
Subjects will be recruited from the clinical practice of the Department of Dermatology or
Division of Rheumatology at Mayo Clinic Florida. Fifteen males and females with RAS will be
enrolled.
The study will consist of 3 phases: a screening phase, a 16 week treatment phase and an 8
week posttreatment observational follow-up phase.
The screening phase will consist of: obtaining informed consent, demographic information,
medical history, inclusion and exclusion criteria, prior and concomitant medication use,
adverse events; collecting vital signs and weight; performing complete physical examination
and limited physical examination; obtaining hematology, serum chemistry, urinalysis,
pregnancy test and providing contraception education.
During the 16-week treatment phase, all subjects receive apremilast.
All subjects who complete the active treatment phase are to enter the 8-week posttreatment
observational follow-up phase.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Duration of RAS Lesions
Secondary Outcome
Adverse Events
Condition
Recurrent Aphthous Stomatitis
Intervention
Apremilast 30mg
Study Arms / Comparison Groups
Single Arm
Description: Apremilast 30mg orally twice daily for 16 weeks, sixteen weeks on active study. Post treatment follow-up period of 8 weeks, in the Treatment of Subjects with Severe Recurrent Aphthous Stomatitis (RAS)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
October 12, 2018
Completion Date
July 14, 2021
Primary Completion Date
July 14, 2021
Eligibility Criteria
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).
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Alison J Bruce, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03690544
Organization ID
18-002914
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Collaborators
Celgene
Study Sponsor
Alison J Bruce, Principal Investigator, Mayo Clinic
Verification Date
June 2022