2024-514659-13-00招募中3 期
Randomized double blind controlled trial comparing the safety and efficacy of apremilast versus placebo in severe forms of recurrent aphthous stomatitis - PREMS - 2019/0411/HP
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 19
- 主要终点
- The primary endpoint will be sustained complete response (CR) (i.e., no oral ulcer at both the Week 12 and Week 14 and Week 16 evaluations), assessed by a blind evaluator (so that the evaluator will not be aware of any digestive complaints from the patient, that may be frequent with apremilast)
研究概览
简要总结
The primary objective of this study is to assess the superiority of apremilast in comparison with placebo to achieve sustained Complete Remission (CR) of oral ulcers, in patients with severe RAS resistant or intolerant to colchicine at Week 12 and Week 14 and Week 16.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.i) At least one large / giant oral ulcer (≥ 1cm in diameter) confirmed by the investigator during the 3 months month preceding inclusion and/or, ii) Multiple simultaneous oral ulcers (≥4), including herpetiform ulcers confirmed by the investigator during the 3 months preceding inclusion and/or, iii) Continuous evolution of oral ulcers, some lesions healing, as newly appearing oral ulcers develop within the 3 months before inclusion and/or, iv) Ulcers occurring at least 7 days each month during the previous 3 months (15) and/or v) Major pain related to oral ulcers interfering with eating, speaking, or swallowing
- •Patient having read and understood the information letter and signed the Informed Consent Form
- •For women: a. Women of childbearing potential : i. Effective contraception according to CTFG contraception recommendations (V1.1 21/09/2020) since at least 4 weeks before randomization and during treatment, And; ii. Negative blood pregnancy test; b. Women surgically sterile (absence of ovaries and/or uterus); c. Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide.
- •Patient able to comply with the study protocol, in the investigator’s judgment
- •Patient affiliated with, or beneficiary of a social security (health insurance) category
排除标准
- •History of clinically significant or uncontrolled disease (as determined by the investigator), which places the subject at unacceptable risk if he/she were to participate in the study.
- •Hypersensitivity of the active substance(s) or to any of the excipients of racecadotril
- •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 (defined by creatinine clearance <30 mL / min estimated by Cockroft-Gault equation), hematologic, immunologic disease, or other major disease that is currently uncontrolled in the opinion of the investigator
- •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 situation in which the oncologist in charge of the patient considers that oncologic risk allows the use of apremilast.
- •Patients with positive blood test for HIV.
- •Any severe 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 the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
- •Patient intending to become pregnant during the study; Women who are not postmenopausal (≥ 12 months of non−therapy-induced amenorrhea) or surgically sterile must have a negative result from a serum pregnancy test within 1 week prior to randomization and use an effective contraception.
- •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 of the administrated product.
- •Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
- •Patient has secondary RAS (e.g., celiac disease, Crohn’s disease, ulcerative colitis, relapsing polychondritis, PFAPFA, AIDS…).
- •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
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP (pregnant or breastfeeding (lactating) woman, deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- •Depression and suicidal ideation, in particular prior history of suicide attempt at any time in the subject’s lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- •Co-medication with a cytochrome P450 3A4 (CYP3A4) enzyme inducer (especially, rifampicin and most anti-epileptic drugs (e.g. carbamazepine, phenytoin)
- •Patient severely underweight patient (BMI < 16 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...)
- •Hypersensitivity of the active substance(s) or to any of the excipients of OTEZLA and placebo
结局指标
主要结局
The primary endpoint will be sustained complete response (CR) (i.e., no oral ulcer at both the Week 12 and Week 14 and Week 16 evaluations), assessed by a blind evaluator (so that the evaluator will not be aware of any digestive complaints from the patient, that may be frequent with apremilast)
The primary endpoint will be sustained complete response (CR) (i.e., no oral ulcer at both the Week 12 and Week 14 and Week 16 evaluations), assessed by a blind evaluator (so that the evaluator will not be aware of any digestive complaints from the patient, that may be frequent with apremilast)
次要结局
未报告次要终点
研究者
Nell MARTY
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (19)
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