2026-526218-10-00招募中2 期
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Participants with Sjogren’s Disease-Associated Sensorimotor or Sensory Polyneuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 34
- 试验地点
- 41
- 主要终点
- Change from baseline in mTCNS total score at the end of Part A
研究概览
简要总结
To evaluate the efficacy of efgartigimod PH20 SC once weekly compared to placebo on SjD-associated SPN or SMPN
研究设计
- 分配方式
- Na
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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 SjD criteria: Fulfilled American College of Rheumatology and the European Alliance of Associations for Rheumatology classification 2016 SjD criteria before screening; Moderate-to-severe disease defined as a ESSDAI ≥ 5 or clinESSDAI ≥ 6 with PNS domain score of ≥ 5 (ie, a score of at least low activity) at screening; Anti-Ro/SS-A positive at a central laboratory at screening
- •Meets the following SjD-associated polyneuropathy criteria: - a neurological examination including NCS consistent with the qualifying diagnosis - neuropathy duration ≤ 5 years - active neuropathic disease within the last 12 months - total mTCNS ≥ 6 - mTCNS sensory sub score < level 3
排除标准
- •Besides the indication under study, known medical conditions that would interfere with an accurate assessment of clinical symptoms of SjD-associated SMPN or SPN or gangliopathy, confound the study results, or puts the participant at undue risk.
- •Associated (also known as secondary) SjD, 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.
- •Evidence of an alternative cause of neuropathy (including vasculitic neuropathy and diabetes mellitus) or insufficient evidence that the neuropathy is attributable to SjD.
- •Any severe SjD manifestation or other health condition not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator’s opinion.
- •Comorbidities (eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic (oral, IV, or IM) glucocorticoids within the previous 12 months.
- •History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years; before first IMP administration.
研究组 & 干预措施
Vyvgart 1 000 mg solution for injection in pre-filled syringe
Test
干预措施: Vyvgart 1 000 mg solution for injection in pre-filled syringe (Drug)
Placebo matching IMP.
Placebo
干预措施: Placebo matching IMP. (Drug)
结局指标
主要结局
Change from baseline in mTCNS total score at the end of Part A
Change from baseline in mTCNS total score at the end of Part A
次要结局
- Change from baseline in mTCNS total score over time
- Change from baseline in Norfolk QoL-DN total score at the end of part A and over time
- Change from baseline in clinESSDAI score at the end of part A and over time
- Change from baseline in ESSDAI score at the end of part A and over time
- Proportion of participants with low disease activity (clinESSDAI < 5) at the end of part A and over time
- Incidence, severity, and relatedness of AEs
- Clinically significant changes in vital signs, physical examination, ECG, and clinical laboratory safety evaluations.
- Change from baseline in NPQ at the end of part A and over time
- Change from baseline in difficulty thinking NRS at the end of part A and over time
- Change from baseline in PGIS, PGIC, CGIS, and CGI scores at the end of part A and over time
- Change from baseline in FACIT-Fatigue scores at the end of part A and over time
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (41)
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