2025-520805-10-00招募中3 期
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Reduction of ≥1 point compared with baseline in aINCAT score at week 24
研究概览
简要总结
To demonstrate the efficacy of empasiprubart IV compared with placebo in improving functional ability
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Part B
- 盲法
- Double (Monitor, Carer, Subject, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- •Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- •Has residual disability and active disease
- •Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors).
排除标准
- •Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- •Sensory CIDP (including sensory-predominant CIDP)
- •Polyneuropathy of other causes
- •Clinical diagnosis of systemic lupus erythematosus (SLE)
- •Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
结局指标
主要结局
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
次要结局
- Change from baseline in I-RODS centile points score - up to 24 weeks (part A)
- Change from baseline in MRC-SS at week 24
- Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
- Time to reduction of ≥1 point from baseline in aINCAT score - up to 24 weeks
- Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24
- Change from baseline in grip strength (3-day moving average) of both hands over time and change from baseline in grip strength (daily average) for both hands
- Change from baseline in MRC-SS over time. Up to 96 weeks (Part B)
- Change from baseline in aINCAT score over time
- Change from baseline in EQ-5D-5L over time
- Change from baseline in RT-FSS over time
- Change from baseline in BPI-SF over time
- PGI-S values over time
- PGI-C values over time
- Incidence and prevalence of ADA against empasiprubart in serum
- Incidence and prevalence of NAb against empasiprubart in serum
- Incidence and severity of AEs
- Incidence of SAEs
- Clinically meaningful changes in laboratory parameters, ECG results, and vital signs
- Absolute values and percentage change from baseline in free C2 and total C2 over time
- Serum concentrations of empasiprubart over time
- Reduction of ≥1 point in aINCAT over time
- Increase of ≥1 point from baseline in aINCAT over time
- Change from baseline in TUG at week 24
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (6)
Loading locations...
相似试验
招募中
3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects with Moderate-to-Severe Plaque PsoriasisPlaque psoriasis2024-519919-34-00Can-Fite Biopharma Ltd.248
招募中
3 期
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)Cold UrticariaNCT07266402Celldex Therapeutics240
撤回
1 期
Phase I, double-blind, randomized, placebo-controlled study investigating the safety, tolerability and concentrations of the study product KAND145 in healthy volunteersOvarian cancer2023-503909-11-00Kancera AB80
招募中
2 期
A clinical study of tulisokibart in people with rheumatoid arthritis (MK-7240-014)Rheumatoid Arthritis2025-521745-25-00Merck Sharp & Dohme LLC58
招募中
2 期
A trial to find the effect of Ginkgo biloba extract EGb 761® and how safe it is in participants with cognitive impairment associated with post COVID-19 syndrome2024-517199-39-00Dr. Willmar Schwabe GmbH & Co. KG400