2024-514539-67-00招募中2 期
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 108
- 试验地点
- 45
- 主要终点
- Change from baseline in modified Rodnan Skin Score (mRSS) at week 24
研究概览
简要总结
To evaluate the efficacy of efgartigimod for SC administration coformulated with rHuPH20 (efgartigimod PH20 SC) compared with placebo (placebo PH20 SC) on skin sclerosis in participants with SSc
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Investigator, Analyst, Monitor, Carer, Subject)
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 aged ≥18 years and the local legal age of consent for clinical studies
- •Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
- •Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
- •Has a Health Assessment Questionnaire–Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
- •Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
- •The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
- •Has uninvolved or mildly thickened skin area in at least 1 injection site
排除标准
- •Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
- •Positive serum test for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
- •Disease or any other medical condition that, in the investigator’s opinion, would confound the study results or put the participants at undue risk. Recent major surgery or intention to have major surgery during the study
- •History of or current alcohol, drug, or medication abuse
- •Pregnant or lactating state or intention to become pregnant during the study
- •Severe renal impairment
- •Significant Pulmonary Arterial Hypertension
- •Severe digital vasculopathy within the past 3 months
- •Skin thickening due to scleroderma mimics or localized scleroderma
- •Scleroderma renal crisis within the past 6 months of participating to the study
- •Another rheumatic autoimmune disease, except for secondary Sjögren’s syndrome or fibromyalgia
- •Another known autoimmune disease or any medical condition that would interfere with an accurate assessment of SSc or puts the participant at undue risk
- •History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 3 years or more before first IMP administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- •Serious or severe active infection that is not sufficiently resolved before baseline OR an active infection that could place the participant at undue risk or confound the study results in the investigator’s opinion
结局指标
主要结局
Change from baseline in modified Rodnan Skin Score (mRSS) at week 24
Change from baseline in modified Rodnan Skin Score (mRSS) at week 24
次要结局
- 1. Change from baseline in mRSS at week 48
- 2. Incidence and severity of treatment-emergent adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation of investigational medicinal product (IMP)
- 6. Change from baseline in Patient Global Assessment (PGA) at weeks 24 and 48
- 3. Clinically meaningful changes in laboratory parameters, electrocardiograms (ECGs), and vital signs
- 4. Proportion of participants who improve in ≥2 or ≥3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)
- 5. Change from baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at weeks 24 and 48
- 7. Change from baseline in Clinician’s Global Assessment (CGA) at weeks 24 and 48
- 8. Annualized rate of decline in forced vital capacity (FVC; in mL) in participants with interstitial lung disease (ILD)
- 9. Efgartigimod serum concentrations over time
- 10. Percent change from baseline in total IgG levels in serum over time
- 11. Incidence and prevalence of antidrug antibodies (ADA) against efgartigimod in serum over time
- 12. Incidence and prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) in plasma over time
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (45)
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