Apremilast for RAS
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|ClinicalTrials.gov Identifier: NCT03690544|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Aphthous Stomatitis||Drug: Apremilast 30mg||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Apremilast 30mg orally twice daily for 16 weeks|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Evaluating the Efficacy of Apremilast in the Treatment of Subjects With Severe Recurrent Aphthous Stomatitis (RAS)|
|Actual Study Start Date :||October 12, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Experimental: Single Arm
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)
Drug: Apremilast 30mg
Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.
- Improvement in duration of RAS lesions [ Time Frame: up to 24 weeks ]Improvement in the duration of oral ulcers will be used to factor the improvement of RAS lesions.
- Percentage change in number of RAS lesions [ Time Frame: up to 24 weeks ]The percentage change in the number of oral ulcers will be used to factor the improvement of RAS lesions.
- Improvement in duration of the remission period between ulcer episodes [ Time Frame: up to 24 weeks ]Improvement in duration of the remission period between ulcer episodes will be used to factor the improvement of RAS lesions.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 weeks ]Type, frequency, severity and relationship of the adverse events to apremilast will be assessed and reported.
- Discontinuation of study participants [ Time Frame: 24 weeks ]Number of sbjects who prematurely discontinue treatment with apremilast due to any adverse event.
- Frequency of clinically significant changes in vital signs and/or laboratory findings [ Time Frame: 24 weeks ]The frequency of clinically significant changes in vital signs and/or laboratory findings will be measured through a complete physical examination using physiological parameters, as well as hematology and serum chemistry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690544
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Alison J Bruce||Mayo Clinic|