CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Apremilast 30mgdrug
Likely dose
Apremilast 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03690544
NCT03690544Phase 4Completed

A Pilot Study Evaluating the Efficacy of Apremilast in the Treatment of Subjects With Severe Recurrent Aphthous Stomatitis (RAS)

Mayo Clinic·interventional·Posted Oct 1, 2018·Updated Jul 14, 2022

In Brief

A Phase 4 clinical trial evaluating Apremilast 30mg for Recurrent Aphthous Stomatitis. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Determination of treatment efficacy and safety of Apremilast in patients with RAS

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartOct 12, 2018
Primary CompletionJul 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.8 years ago

Interventions

Apremilast 30mgdrug

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.