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2021年2月3日

概览

暂无简介。

注册库

who.int

开始日期

2021年2月3日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Zealand University Hospital (Universitetshospital Sjælland)

•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

•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.