Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Sponsor
University Hospital, Rouen
Study ID
NCT04227314
Phase
PHASE3
Status
Recruiting
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Conditions

  • Recurrent Aphtous Stomatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period
  • Placebo oral tablet — DRUG
    Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period,

Study Details

The objective of the study is to assess the superiority of apremilast in comparison with placebo to achieve Complete Remission (CR) of oral ulcers at Week 12, in patients with severe Recurrent aphtous stomatitis resistant or intolerant to colchicine.

Key Dates

First listed
Jan 13, 2020
Start date
Apr 10, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period
  • Placebo Comparator: Placebo
    Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period

Primary Outcome Measure

Presence of oral ulcer during clinical examination [ Time Frame: Week 12 ]

Central Contacts