EUCTR2020-005661-14-DE进行中（未招募）1 期
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren's syndrome (NEPTUNUS-1) - NEPTUNUS-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 268
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
- 性别
- All
入选标准
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •1. Signed informed consent must be obtained prior to participation in the study
- •2. Women and men = 18 years of age
- •3. Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria(Shiboski et al 2017)
- •4. Time since diagnosis of Sjögren's of = 7.5 years at screening
- •5. Positive anti-Ro/SSA antibody at screening
- •? Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review
- •? Enrollment of anti-Ro/SSA-negative patients will be limited up to =10% of the study population
- •6. Screening ESSDAI score of = 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic.
- •7. Stimulated whole salivary flow (sSF) rate of = 0.05 mL/min at screening
- •8. Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study
- •9. Patients taking hydroxychloroquine (= 400 mg/day), methotrexate (= 25 mg/week) or azathioprine (= 150 mg/day) alone or in combination, are allowed to continue their medication,
- •and must have been on a stable dose for at least 30 days prior to randomization. Stable dose within the predefined dose limits should be maintained throughout the 52 weeks of the blinded treatment period of the study
- •10. Patients taking systemic corticosteroids have to be on a stable dose of = 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization. Stable dose should be maintained throughout the 52 weeks of the blinded treatment period of the study, however
- •limited increases of the corticosteroid dose for a limited time and tapering of background steroids are allowed during the course of the study as described in Section 6.2.1
- •11. Patients taking
- •? disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in
- •inclusion criterion #9 must or
- •? the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to
- •randomization unless a cholestyramine wash-out has been performed.
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
- •? Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains
- •? Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain
- •? Systemic sclerosis
- •? Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's syndrome organ domain assessments.
- •2. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer, or longer if required by local regulations
- •3. Prior treatment with ianalumab
- •4 Prior use of a B-cell depleting therapy other than ianalumab (e.g.,
- •rituximab, other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb)
- •within 36 weeks prior to randomization or as long as B-cell count is less than the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is lower)
- •5. Prior treatment with any of the following:
- •-within 24 weeks prior to randomization : iscalimab (anti CD-40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFa) biologic agents, immunoglobulins (i.v./s.c.) plasmapheresis;
- •-within 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed in inclusion criterion #9
- •6.Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose >10 mg/day
- •7.Any one of the following laboratory values at screening:
- •? Hemoglobin levels < 8.0 g/dL
- •? White blood cells (WBC) count < 2.0 x 103/µL
- •? Platelet count < 80 x 103/µL
- •? Absolute neutrophil count (ANC) < 0.8 x 103/µL (one re-test is allowed during the screening period)
- •8.Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms
- •9.History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20)
- •10.History of major organ, hematopoietic stem cell or bone marrow transplant
- •11.Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study
- •12.Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study
- •13.Receipt of live/attenuated vaccine within a 4-week period prior to randomization
- •14.History of primary or secondary immunodeficiency, including a positive human
研究者
相似试验
进行中（未招募）
1 期
A clinical study to investigate if ianalumab is effective and safe in the treatment of active Sjögren`s syndromeActive Sjögren's syndromeMedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2020-005661-14-ATovartis Pharma AG268
已完成
2 期
A randomized, double-blind, placebo controlled, 2- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis (NASH)Extra amount of fat in liver cells that is not caused by alcohol use10019654NL-OMON46032ovartis15
进行中（未招募）
1 期
A 2 part clinical study that will evaluate the safety and effectiveness of LJN452A to treat patients with fatty liver disease for a period of 12 weeks. The first part will be used for LJN452 dose selection for the second part of the study.on-alcoholic Steatohepatitis (NASH)MedDRA version: 19.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2015-005215-33-ESovartis Farmacéutica, S.A.350
进行中（未招募）
1 期
A clinical study to investigate if ianalumab is effective and safe in the treatment of active Sjögren`s syndromeActive Sjögren's syndromeMedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2020-005661-14-PLovartis Pharma AG268
进行中（未招募）
1 期
A 2 part clinical study that will evaluate the safety and effectiveness of LJN452A to treat patients with fatty liver disease for a period of 12 weeks. The first part will be used for LJN452 dose selection for the second part of the study.EUCTR2015-005215-33-ITovartis Pharma AG250