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临床试验/EUCTR2020-002081-13-NL
EUCTR2020-002081-13-NL进行中（未招募）1 期

A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in subjects with systemic sclerosis (SSc)

Gesynta Pharma AB0 个研究点目标入组 80 人开始时间: 2020年8月17日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
80
研究概览入排标准研究者记录与标识符相似试验

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. Subjects must provide signed and dated written informed consent before the conduct of any study-specific procedures.
  • •2. Male and female subjects aged 18-75 years inclusive.
  • •3. SSc diagnosed according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria (van den Hoogen F et al. 2013).
  • •Subjects with signs of other autoimmune diseases (e.g. Sjögren’s syndrome, myositis, rheumatoid arthritis) could be included if SSc is the dominating phenotype.
  • •4. Raynaud attacks typically =7 times per week during the last 4 weeks prior to screening despite background medication (only allowed vasodilatory therapy is calcium channel blockers or PDE-5 inhibitors).
  • •5. Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for 4 weeks after the last dose of IMP in such manner that the risk of pregnancy is minimised.*
  • •6. Women must not be pregnant or breastfeeding.
  • •7. Male subjects to agree to use condom in combination with use of contraceptive methods with a failure rate of <1% to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first date of dosing until 3 months after last dosing of the IMP.
  • •8. Ability of subjects to participate fully in all aspects of this clinical trial.
  • •* A woman is considered of childbearing potential, i.e. fertile, following
  • •menarche and until becoming post-menopausal unless permanently
  • •sterile. Permanent sterilisation methods include hysterectomy, bilateral
  • •salpingectomy and bilateral oophorectomy. A postmenopausal state is
  • •defined as no menses for 12 months without an alternative medical
  • •cause. A high follicle stimulating hormone (FSH) level in the
  • •postmenopausal range may be used to confirm a post-menopausal state
  • •in women not using hormonal contraception or hormonal replacement
  • •therapy. However, in the absence of 12 months of amenorrhea, a single
  • •FSH measurement is insufficient.
  • •*Methods that can achieve a failure rate of <1% per year when used
  • •consistently and correctly are considered as highly effective birth control
  • •methods. Such methods include combined (oestrogen and progestogen
  • •containing) hormonal contraception associated with inhibition of
  • •ovulation (oral, Intravaginal, and/or transdermal); progestogen-only
  • •hormonal contraception associated with inhibition of ovulation (oral,
  • •injectable, and/or implantable2); intrauterine device (IUD)2;
  • •intrauterine hormone-releasing system (IUS); bilateral tubal occlusion2;
  • •vasectomised partner; sexual abstinence.
  • •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 65
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 15

排除标准

  • •1. SSc disease duration of greater than 120 months from first non-Raynaud manifestation
  • •2. Current smokers or stopped smoking or used nicotine in any form <3 months prior to Visit 1.
  • •3. Dose-change or initiation of vasodilating substances (calcium blockers or PDE-5 inhibitors) within 4 weeks prior to Visit 1. Subjects are not allowed to use a combination of calcium blockers and PDE-5 inhibitors from 4 weeks prior to Visit 1 and throughout the study.
  • •Note: The subjects could be re-screened if they fulfil this exclusion criterion.
  • •4. Use of iloprost or other intravenous (iv) or per os (po) prostacyclin receptor agonist within 4 weeks prior to Visit 1.
  • •5. Ongoing treatment with immunosuppressive therapies (other than mycophenolate) including, but not restricted to; cyclophosphamide, azathioprine, methotrexate, or cyclosporine, or use of those medications within 4 weeks prior to Visit 1.
  • •Note: Subjects could be included if they have been treated with a stable dose of mycophenolic acid during 4 weeks prior to study entry.
  • •6. Use of systemic corticosteroids within 4 weeks prior to Visit 1 and during the course of the study.
  • •7.Use of moderate or strong CYP3A4 inhibitors within 5 terminal half-lives or one week, whichever is longer, prior to Visit 2. Examples of a moderate or strong CYP3A4 inhibitors are diltiazem, verapamil and grapefruit juice
  • •8. Concurrent serious medical condition, with special attention to cardiovascular conditions, which in the opinion of the Investigator makes the subject not suitable for this study.
  • •9. Prolonged corrected QT interval by Fredericia (QTcF) defined as a mean QTcF >450 msec at Visit 1, or at Visit 2 (prior randomisation).
  • •10. Creatinine clearance <50 mL/min (determined by Cockcroft-Gault equation).
  • •11. Active digital ulcer (DU) within 4 weeks prior to Visit 1.
  • •12. Have known allergies to any components of the GS-248 formulation.
  • •13. Clinically meaningful laboratory abnormalities at Screening (Visit 1), as determined and documented by the Investigator.
  • •14. Positive test results for HBsAg, HCVAb or HIV-1 and/or -2 antibodies at Screening (Visit 1).
  • •15. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
  • •16. Subject is mentally or legally incapacitated at the time of screening or has a history of clinically significant psychiatric disorders that would impact the subject’s ability to participate in the study according to the Investigator.
  • •17. Malignancy within the past 5 years except for in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.
  • •18. Planned major surgery within the duration of the study.
  • •19. Blood donation (or corresponding blood loss) within 12 weeks prior to Visit 1.
  • •20. Participation in another interventional clinical study involving IMP within 4 weeks or given an experimental drug within 5 half-lives, whichever longest, prior to Visit 1.
  • •Exclusion Criterion for Cold Challenge
  • •At Visit 2: Finger temperature below 27°C after acclimatising at an ambient temperature of 23°C (±2°C) for a period of 20 minutes.
  • •Randomization Criteria:
  • •In addition to fulfilling all inclusion and exclusion criteria, subjects must fulfil the following criteria to be randomised:
  • •1. =7 RP attacks during the last week of the run-in period as captured in the eDiary, with no more than 2 days without RP attacks.
  • •2. Compliance with the eDiary during the 7 most recent days prior to
  • •baseline (Vi

研究者

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