EUCTR2021-000049-42-DK进行中（未招募）1 期
Orismilast for the treatment of mild to severe hidradenitis suppurativa; A phase 2, open-label, proof of concept trial comparing the response to an oral tablet formulation of orismilast in adult patients with mild, moderate, and severe hidradenitis suppurativa; A single-centre, prospective, single arm, investigator-initiated clinical trial with 16 weeks twice times daily oral treatment, with extension of total treatment duration to 52 weeks for responders - OSIRIS
Zealand University Hospital (Universitetshospital Sjælland)0 个研究点目标入组 24 人开始时间: 2021年2月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female adult patients, 18 years of age or older.
- •2.Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
- •3.Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
- •4.Has a total inflammatory lesions (AN) count of greater than or equal to 2.
- •5.Total draining fistula count of less than or equal to 30.
- •6.A stable analgesic dose for 2 weeks prior to baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Presence of active skin lesions other than HS that could interfere with the assessment of HS.
- •2.Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
- •3.Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
- •4.Any oral antibiotic within 28 days prior to baseline visit.
- •5.Receipt of a live vaccine within 14 days prior to screening.
- •6.Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
- •7.Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
- •8.Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating.
- •9.Active systemic infection and/or fever – or clinical signs of local infection (stinging, increased soreness, burning sensation, erythematous perilesional halo or other signs of infection) - during the last 2 weeks prior to first drug administration.
- •10.History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
- •11.Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L).
- •12.Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •13.Relevant chronic or acute infections (exception: common cold), as determined by the investigator, including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- •a. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA PCR is considered positive.
- •14.Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug administration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).
- •15.Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, and >2-fold ULN elevation in alkaline phosphatase.
- •16.Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than HS, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would compromise the safety of the patient or compromise the quality of the data, make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial.
- •17.Planned use of laser or other hair removal procedures over HS-affected areas during the trial period.
- •18.Planned HS surgery during the trial period.
研究者
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