Apremilast for RAS

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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

Early Phase 1

Study Type

Interventional


Primary Outcome

Improvement in duration of RAS lesions

Secondary Outcome

 Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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

February 1, 2022

Primary Completion Date

February 1, 2022

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

September 2021