A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 26
- 主要终点
- Change from baseline in SSSD oral dryness score
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
详细描述
This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、医护人员、研究者)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
- Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
- Seropositive for anti-Ro/SSA antibodies at screening
- SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
- Screening ESSDAI biologic and/or hematologic domain > 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
- Stimulated whole salivary flow (sSF) rate > 0.3 mL/min at screening
- Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
- Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.
排除标准
- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
- Systemic sclerosis (SSc)
- Any other associated 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 disease organ domain assessments.
- Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
- Prior treatment with B-cell-depleting therapy (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 (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
- Prior treatment with ianalumab
- Prior treatment with any of the following within the given period prior to Screening:
- Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
- Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
- History of hypersensitivity to any of the study drugs or their 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).
研究组 & 干预措施
Placebo
Placebo once monthly solution for injection for subcutaneous use.
干预措施: Placebo (Drug)
VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
干预措施: VAY736 (Drug)
结局指标
主要结局
Change from baseline in SSSD oral dryness score
时间窗: Baseline to Week 52
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
次要结局
- Change from baseline in SSSD summary score(Baseline to Week 52)
- Change from baseline in ESSPRI score(Baseline to Week 52)
- Change from baseline in stimulated whole salivary flow (sSF)(Baseline to Week 52)
- Change from baseline in Patient's Global Assessment (PaGA) NRS score(Baseline to Week 52)
- Proportion of participants achieving SSSD response(Week 52)
- Proportion of participants achieving ESSPRI response(Week 52)
- Change from baseline in SSSD eye dryness score(Baseline to Week 52)
- Change from baseline in FACIT-Fatigue score(Baseline to Week 52)
- Change from baseline in Sjögren's-Related Quality of Life (SRQoL) score(Baseline to Week 52)
研究者
研究点 (26)
标识符
- NCT 编号
- NCT07621809
- 其他研究编号
- CVAY736A22301, 2025-522271-29-00, 2025
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (6年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com