NL-OMON48111尚未招募2 期
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome. - M19-956
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult male or female, between 18 and 75 years of age, inclusive, at time of
- •the Screening.
- •Primary Sjogren's syndrome (pSS) diagnosed according to the American College
- •of Rheumatology (ACR)/EULAR 2016 Criteria.
- •Lymphocyte focus score (local lymphocytic infiltrates) >=1 in sub labial
- •salivary gland specimen. Subjects with biopsy obtained 24 months prior to
- •Screening and meeting this criterion will be eligible but must have a sub
- •labial biopsy obtained at the Baseline Visit. Subjects without a prior sub
- •labial biopsy within 24 months of Screening will obtain a biopsy for a
- •lymphocyte focus score at Screening.
- •EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) >=5 at Screening and
- •EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) >= 6 at Screening and
排除标准
- •1) Female subject who is pregnant, breastfeeding, or considering becoming
- •pregnant during the study or for approximately 84 days.
- •2) Subjects must have discontinued all immunosuppressants (i.e., azathioprine ,
- •methotrexate (MTX), leflunomide (LEF), hydroxychloroquine (HCQ), chloroquine,
- •sulfasalazine, mycophenolate mofetil, rituximab, other biologics, or JAK
- •inhibitors), other than corticosteroids (equivalent to prednisone <= 10 mg/day),
- •prior to the Baseline, with the following washout:
- •HCQ must be discontinued >= 6 months prior to Baseline
- •LEF must be discontinued >= 6 months prior to Baseline
- •1 year for rituximab OR 6 months if B cells have returned to pretreatment
- •level or normal reference range (local laboratory) if pretreatment levels are
- •not available;
- •Discontinuation or modification of all other immunosuppressants must occur >=
- •4 weeks prior to Baseline or at least five times the mean terminal elimination
- •half-life of the drug before undergoing the Baseline, whichever is longer.
- •3) Subject must not receive IV anti-infectives within 35 days prior to Baseline
- •or oral/intramuscular (IM) anti-infectives within 14 days prior to the Baseline
研究者
相似试验
进行中（未招募）
1 期
A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's DiseaseModerate To Severe Crohn's Disease (CD)MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-003359-43-HRPfizer Inc., 235 East 42nd Street, New York, NY 10017255
进行中（未招募）
1 期
A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseModerate To Severe Crohn’s Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-003359-43-DEPfizer Inc.255
进行中（未招募）
1 期
This is a double-blind, randomized, vehicle controlled, two-way crossover repeated administration study performed in presbyopic subjects.Presbyopia is part of the natural ageing process of the eye. It is usually noticed at around the age of 40 years. The main symptom of this condition is a progressive blurring of vision when performing near tasks such as reading, sewing, working at a computer, using a tablet mobile phone etc. The individual may complain of headaches and become more reliant on better illumination when attempting to see fine detail close up.EUCTR2016-001091-30-SIORASIS Pharmaceuticals Ltd37
进行中（未招募）
1 期
A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseModerate To Severe Crohn’s Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-003359-43-PLPfizer Inc., 66 Hudson Boulevard East, New York, NY 10001255
进行中（未招募）
1 期
A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseModerate To Severe Crohn’s Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-003359-43-BEPfizer Inc., 235 East 42nd Street, New York, NY 10017255