Actively Recruiting
Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
Led by University Hospital, Rouen · Updated on 2026-02-17
134
Participants Needed
21
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 6518 years with severe primary recurrent aphthous stomatitis resistant or intolerant to colchicine at 1mg/day or more for at least 3 months
- Severity defined by at least one of: giant oral ulcer 651cm, multiple simultaneous ulcers (4 or more) including herpetiform ulcers, continuous evolving ulcers, ulcers lasting at least 7 days each month for 3 months, or major pain affecting eating, speaking, or swallowing
- At least one oral ulcer present on the day of inclusion
- Patient has read and signed informed consent
- Women not postmenopausal and not planning children agree to use two adequate contraception methods or remain abstinent
- Ability to comply with study protocol as judged by investigator
- Affiliated with or beneficiary of social security or health insurance
You will not qualify if you...
- Any significant medical condition, laboratory abnormality, or psychiatric illness preventing study participation
- Secondary recurrent aphthous stomatitis due to other diseases (e.g., celiac disease, Crohn's disease)
- Depression or suicidal thoughts
- Use of cytochrome P450 3A4 enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin)
- Severely underweight (BMI < 18.5 kg/m2)
- Inability to attend regular follow-up
- Other inflammatory oral diseases affecting data interpretation (e.g., lichen planus)
- Medical conditions requiring systemic treatment that confound data (e.g., lupus, rheumatoid arthritis)
- Current enrollment in another therapeutic trial
- Uncontrolled major diseases affecting heart, lungs, liver, kidneys, or immune system
- Malignancy or history of malignancy in past 5 years except certain treated skin or cervical cancers
- Positive HIV blood test
- Recent bacterial, viral, or fungal infections requiring treatment within 4 weeks prior to screening
- Live vaccine received within 3 months prior or planned during study
- Pregnancy, breastfeeding, or intention to become pregnant
- Use of systemic therapies effective against RAS within 4 weeks prior to randomization
- Use of biologic therapies including anti-TNF within 5 half-lives
- Prior apremilast treatment or participation in apremilast studies
- Any condition or lab abnormalities posing unacceptable risk
- Galactose intolerance, lactase deficiency, or glucose/galactose malabsorption
- Deemed unreliable or unable to comply with protocol
- Alcohol dependency
- Male intending to father a child during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Chu Amiens
Amiens, France, 80054
Not Yet Recruiting
2
Ap-Hp Avicenne
Bobigny, France, 93000
Actively Recruiting
3
Chu Bordeaux
Bordeaux, France, 33076
Actively Recruiting
4
Chru Brest
Brest, France, 29200
Actively Recruiting
5
Ch Creteil
Créteil, France, 94010
Actively Recruiting
6
Ch Le Mans
Le Mans, France, 72037
Actively Recruiting
7
Chu Lille
Lille, France, 59000
Actively Recruiting
8
Hcl Hopital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
9
Ap-Hm La Timone
Marseille, France, 13385
Actively Recruiting
10
Chu Montpellier
Montpellier, France, 34295
Actively Recruiting
11
Chu Nantes
Nantes, France, 44000
Actively Recruiting
12
CHU NICE
Nice, France, 06000
Actively Recruiting
13
Ap-Hp Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
14
Ap-Hp Pitie-Salpetriere
Paris, France, 75013
Not Yet Recruiting
15
Hopital Cochin
Paris, France, 75014
Actively Recruiting
16
Chu Reims
Reims, France, 51092
Actively Recruiting
17
Chu Rouen
Rouen, France, 76031
Actively Recruiting
18
Ch Saint-Brieux
Saint-Brieuc, France, 22023
Not Yet Recruiting
19
Chu Saint-Etienne
Saint-Etienne, France, 42055
Not Yet Recruiting
20
Chu Toulouse
Toulouse, France, 31059
Actively Recruiting
21
Chru Tours
Tours, France, 37170
Actively Recruiting
Research Team
P
Pascal JOLY, Pr
CONTACT
J
Julien BLOT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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