A Pilot, Open-Label, Phase 2, Single-Center, Repeat Dose, Proof-of-Concept Safety, Pharmacodynamics and Efficacy Study of Orally Administered Dapansutrile Capsules in Subjects with Schnitzler’s Syndrome

Olatec Therapeutics LLC0 个研究点目标入组 10 人开始时间: 2018年1月16日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•1)Male and female subjects 18 years old or older
•2)Prior diagnosis of Schnitzler’s syndrome
•3)Presence of Schnitzler’s syndrome that is well controlled by and responsive to a stable dose of anakinra for at least 3 months prior to the Screening/Baseline visit
•4)Grade 0 SchS symptoms at the Screening/Baseline visit
•5)Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Investigator
•6)Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study and other prohibited medications as outlined in the protocol.
•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 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1)Pregnant, nursing or intent to become pregnant during the study
•2)Not responsive or well controlled by anakinra therapy for at least 6 weeks prior to the Screening/Baseline visit
•3)Use or planned use of any prohibited concomitant medications/therapies such as immunotherapies or corticosteroids during the study (until relapse and resumption of anakinra injections)
•4)Active infection within 3 days prior to the Screening/Baseline visit
•5)History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
•6)Any other concomitant medical or psychiatric conditions, including alcohol or substance abuse, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing protocol requirements
•7)Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Screening/Baseline visit
•8)Enrollment in any study previously sponsored by Olatec Therapeutics LLC, specifically Study OLT1177-01, Study OLT1177-02, Study OLT1177-03 or Study OLT1177-04 or Study OLT1177-05

发起方