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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

2020年8月7日 更新者：LEO Pharma

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

研究概览

地位

完全的

条件

干预/治疗

详细说明

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle.

If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

研究类型

介入性

注册 (实际的)

722

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • British Columbia
      • Surrey、British Columbia、加拿大、V3R 6A7
        • Dr. Chih-ho Hong Medical
      • Vancouver、British Columbia、加拿大、V6E 4M3
        • Pacific Dermaesthetics
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3M 3Z4
        • Wiseman Dermatology Research
    • New Brunswick
      • Bathurst、New Brunswick、加拿大、E2A 4Z9
        • Maritime Medical Research Centre
      • Fredericton、New Brunswick、加拿大、E3B 1G9
        • Brunwick Dermatology Center
    • Ontario
      • Ajax、Ontario、加拿大、L1S 7K8
        • CCA Medical Research
      • Hamilton、Ontario、加拿大、L8N 1V6
        • Dermatrials Research Incorporated
      • London、Ontario、加拿大、N6A 3B4
        • The Guenther Dermatology Research Centre
      • Markham、Ontario、加拿大、L3P 1X2
        • Lynderm Research
      • Peterborough、Ontario、加拿大、K9J 5K2
        • Skin Center for Dermatology
      • Waterloo、Ontario、加拿大、N2J 1C4
        • K. Papp Clinical Research
    • Quebec
      • Quebec City、Quebec、加拿大、J2B 5L4
        • Clinique du Dre Isabelle Delorme Inc
  • 德国
      • Dresden、德国、01307
        • Klinik und Poliklinik für Dermatologie
      • Erlangen、德国、91054
        • Universitätsklinikum Erlangen
      • Essen、德国、54122
        • Universitätsklinikum Essen (AöR), Klinik für Dermatologie
      • Gera、德国、07548
        • SRH Wald-Klinikum Gera
      • Hamburg、德国、20354
        • SCIderm GmbH
      • Lubeck、德国、23538
        • UKSH - Campus Lübeck
      • Mahlow、德国、15831
        • Michael Sebastian
      • Munchen、德国、80337
        • LMU Poliklinik Derma & Allergo
      • Schweinfurt、德国、97421
        • Gemein. Weber & Crainic
  • 法国
      • Brest、法国、29609
        • CHRU de Brest - Hôpital Morvan
      • Nice、法国、06202
        • C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
      • Rennes、法国、35033
        • CHU de Rennes - Hopital Pontchaillou
      • Valence、法国、26000
        • Centre Hospitalier de Valence
    • Saint-Etienne
      • Saint Etienne、Saint-Etienne、法国、42055
        • C.H.U. de Saint-Etienne Service de Dermatologie
  • 波兰
      • Kraków、波兰、31-123
        • Małopolskie Centrum Kliniczne
      • Lublin、波兰、20-079
        • Nzoz Med-Laser
      • Poznań、波兰、60-425
        • Solumed
      • Rzeszów、波兰、35-030
        • Kliniczny Szpital Wojewódzki, Klinika Dermatologii
  • 美国
    • California
      • Fremont、California、美国、94538
        • Center for Dermatology Clinical Research
      • Santa Monica、California、美国、90404
        • Clinical Science Institute
    • Colorado
      • Denver、Colorado、美国、80210
        • Colorado Medical Research Center
    • Florida
      • Miami、Florida、美国、33144
        • International Dermatology Research
    • Illinois
      • Arlington Heights、Illinois、美国、60005
        • Arlington Dermatology
    • Kentucky
      • Louisville、Kentucky、美国、40217
        • Derm Research
    • Maryland
      • Rockville、Maryland、美国、20850
        • DermAssociates
    • Michigan
      • Clarkston、Michigan、美国、48346
        • Clarkston Skin Research
      • Detroit、Michigan、美国、48202
        • Henry Ford Medical Center - New Center One
      • Kalamazoo、Michigan、美国、49009
        • Beyer Research
    • New Jersey
      • East Windsor、New Jersey、美国、08520
        • Psoriasis Treatment Center of Central NJ
    • New York
      • New York、New York、美国、10029
        • Mount Sinai School of Medicine
      • New York、New York、美国、10075
        • Sadick Research Group
      • Rochester、New York、美国、14623
        • Skin Search of Rochester
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • UPMC Department of Dermatology
    • Tennessee
      • Goodlettsville、Tennessee、美国、37072
        • Rivergate Dermatology Clinical Research Center
      • Knoxville、Tennessee、美国、37922
        • The Skin Wellness Center
      • Nashville、Tennessee、美国、37215
        • Tennessee Clinical Research Center
    • Texas
      • San Antonio、Texas、美国、78229
        • Clinical Trials of Texas
      • Webster、Texas、美国、77598
        • Center for Clinical Studies
    • Washington
      • Spokane、Washington、美国、99202
        • Premier Clinical Research
  • 英国
      • Salford、英国、M6 8HD
        • Dermatopharmacology Department
    • Cambridgeshire
      • Wansford、Cambridgeshire、英国、PE8 6PL
        • Wansford and Kings Cliffe Prac
    • Derbyshire
      • Chesterfield、Derbyshire、英国、S40 4AA
        • Ashgate Medical Practice
    • Leicstershire
      • Burbage、Leicstershire、英国、LE10 2SE
        • Burbage Surgery
    • Northamptonshire
      • Wellingborough、Northamptonshire、英国、NN8 4RW
        • Albany House Medical Centre
    • Warwickshire
      • Leamington Spa、Warwickshire、英国、CV32 4RA
        • Sherbourne Medical Centre
    • West Yorkshire
      • Leeds、West Yorkshire、英国、LS7 4SA
        • Chapel Allerton Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

INCLUSION CRITERIA:

  • A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with maximum of 100 g of trial medication per week
  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)
  • A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 ('mild') for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion/Location

For subjects participating in hypothalamic-pituitary-adrenal (HPA)-axis testing, furthermore:

  • An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least 'moderate' affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1.

EXCLUSION CRITERIA:

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:

    • etanercept - within 4 weeks prior to Visit 1
    • adalimumab, infliximab - within 8 weeks prior to Visit 1
    • ustekinumab - within 16 weeks prior to Visit 1
    • secukinumab - within 12 weeks prior to Visit 1
    • other products - within 4 weeks/5 half-lives prior to Visit 1 (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to Visit 1
  • Systemic treatment with apremilast within 4 weeks prior to Visit 1
  • Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
  • Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
  • Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial

For subjects participating in HPA-axis testing, furthermore:

  • Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
药品：LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
安慰剂比较：LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
药品：LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to First Relapse
大体时间：From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)

次要结果测量

结果测量
措施说明
大体时间
Proportion of Days in Remission During the Maintenance Phase
大体时间：From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Number of Relapses During the Maintenance Phase
大体时间：From Randomisation (Week 4) until End of Treatment (Week 56)
Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
From Randomisation (Week 4) until End of Treatment (Week 56)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

LEO Pharma

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月15日

初级完成 (实际的)

2019年6月26日

研究完成 (实际的)

2019年6月26日

研究注册日期

首次提交

2016年9月9日

首先提交符合 QC 标准的

2016年9月13日

首次发布 (估计)

2016年9月14日

研究记录更新

最后更新发布 (实际的)

2020年8月20日

上次提交的符合 QC 标准的更新

2020年8月7日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LP0053-1004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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