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Compares treatment options for Recurrent Aphtous Stomatitis
Official title Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
ClinicalTrials.gov ID: NCT04227314
What this study is testing
What is Apremilast?
Apremilast is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent aphtous stomatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Male or female patients aged ≥18 years old with severe primary RAS resistant to colchicine prescribed at a dose of 1mg/day or more for at least 3...
- Severity of primary oral aphtous ulcer is defined by the presence of at least one of the following criteria:
- i) - At least one giant oral ulcer (≥ 1cm in diameter) confirmed by the investigator during the month preceding inclusion and/or, ii) - Multiple...
- \- In all cases, patients must have at least one oral ulcer on the date of inclusion
- 2\. Patient having read and understood the information letter and signed the Informed Consent Form 3. For women who are not postmenopausal and who do...
You likely can't join if
- Patient has any significant medical condition, significant laboratory abnormality, or psychiatric illness that would prevent the subject from...
- Patient has secondary RAS (e.g., celiac disease, Crohn's disease, ulcerative colitis, relapsing polychondritis, PFAPFA, AIDS…).
- Depression and suicidal ideation
- Co-medication with a cytochrome P450 3A4 (CYP3A4) enzyme inducer ( especially, rifampicin and most anti-epileptic drugs (e.g. carbamazepine...
- Severely underweight patient (BMI \< 18.5 kg/m2)
- Patient cannot be followed regularly.
See the full eligibility criteria
- 1\. Male or female patients aged ≥18 years old with severe primary RAS resistant to colchicine prescribed at a dose of 1mg/day or more for at least 3 months, or intolerant to colchicine
- Severity of primary oral aphtous ulcer is defined by the presence of at least one of the following criteria:
- i) - At least one giant oral ulcer (≥ 1cm in diameter) confirmed by the investigator during the month preceding inclusion and/or, ii) - Multiple simultaneous oral ulcers ( ≥4), including herpetiform ulcers confirmed by...
- \- In all cases, patients must have at least one oral ulcer on the date of inclusion
- 2\. Patient having read and understood the information letter and signed the Informed Consent Form 3. For women who are not postmenopausal and who do not plan on having children anymore: agreement to remain abstinent or...
- Patient has any significant medical condition, significant laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Patient has secondary RAS (e.g., celiac disease, Crohn's disease, ulcerative colitis, relapsing polychondritis, PFAPFA, AIDS…).
- Depression and suicidal ideation
- Co-medication with a cytochrome P450 3A4 (CYP3A4) enzyme inducer ( especially, rifampicin and most anti-epileptic drugs (e.g. carbamazepine, phenytoin)
- Severely underweight patient (BMI \< 18.5 kg/m2)
- Patient cannot be followed regularly.
- Patient has any other inflammatory oral disease, which confounds the ability to interpret data from the study (ie, lichen planus, auto immune bullous diseases with oral involvement),
- Patient has any medical condition that requires systemic treatment which may confound the ability to interpret data from the study (ie, lupus erythematosus, rheumatoid arthritis...)
- Patient is currently enrolled in any other therapeutic trial.
- Other than RAS, subject has any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major...
- Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 5 years, except for treated (ie, cured) basal cell or squamous cell carcinomas, in situ cervix carcinoma, or any...
- Patient with positive blood test for HIV.
- Any bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and...
- Patient has received a live vaccine within 3 months of baseline or plans to do so during study.
- Patient is a pregnant or breastfeeding (lactating) woman or intending to become pregnant during the study; Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have...
- Patient has used systemic therapy which may potentially be effective in RAS within four weeks prior to randomization (including, but not limited to corticosteroids, azathioprine, levamisole, thalidomide).
- Patient has used biologic therapy including anti TNF within 5 pharmacokinetic half-lives.
- Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
- Patient has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Galactose intolerance, lactase deficiency or glucose/galactose malabsorption
- Patient is deemed unreliable or for any reason not able to comply with the protocol
- Patient with alcohol dependency
- Male patient intending to conceive a child with his partner
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bobigny, France
- Bordeaux, France
- Brest, France
- Créteil, France
- Le Mans, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Reims, France
- Rouen, France
- Saint-Brieuc, France
- Saint-Etienne, France
- Toulouse, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bobigny, France; Bordeaux, France; Brest, France; Créteil, France; Le Mans, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.