A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
概览
- 阶段
- 3 期
- 干预措施
- Efgartigimod PH20 SC
- 疾病 / 适应症
- 未指定
- 发起方
- argenx
- 入组人数
- 631
- 试验地点
- 802
- 主要终点
- Change from baseline in clinESSDAI score at week 48
- 状态
- 进行中（未招募）
- 最后更新
- 16天前
概览
简要总结
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
研究者
入排标准
入选标准
- •Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- •Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)
排除标准
- •Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy
- •Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- •Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
- •Use of cyclophosphamide ≤ 24 weeks prior to screening
- •Anti-CD20 or anti-CD19 antibody received \< 6 months before screening
研究组 & 干预措施
Double-blinded treatment period: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
干预措施: Efgartigimod PH20 SC
Double-blinded treatment period: Placebo PH20 SC
Participants receiving placebo PH20 SC during the double-blinded treatment period
干预措施: Placebo PH20 SC
Open-label treatment period
Participants receiving efgartigimod PH20 SC during the open-label treatment period
干预措施: Efgartigimod PH20 SC
结局指标
主要结局
Change from baseline in clinESSDAI score at week 48
时间窗: Up to 48 weeks
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
次要结局
- Change from baseline in ESSDAI score at week 48(Up to 48 weeks)
- Change from baseline in DiSSA total score at week 48(Up to 48 weeks)
- Proportion of participants with low disease activity (clinESSDAI < 5) at week 48(Up to 48 weeks)
- Proportion of responders on STAR (defined as ≥ 5 points) at week 48(Up to 48 weeks)
- Change from baseline in DiSSA joint pain item at week 48(Up to 48 weeks)
- Change from baseline in DiSSA sicca domain at week 48(Up to 48 weeks)
- Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48(Up to 48 weeks)
- Change from baseline in clinESSDAI score at week 24(Up to 24 weeks)