2023-508293-28-00已完成3 期
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 28
- 主要终点
- Responder rate: A responder is defined as a subject with a total improvement score(TIS) ≥ 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs).
研究概览
简要总结
The primary objective of this study is to assess the efficacy of IgPro20 SC doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS) assessments at Weeks 17, 21, and 25.
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
- 是
入选标准
- •male or female subjects ≥ 18 years of age with diagnosis of at least probable idiopathic inflammatory myopathies per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure, and disease severity defined by Physician global visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
排除标准
- •Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
结局指标
主要结局
Responder rate: A responder is defined as a subject with a total improvement score(TIS) ≥ 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs).
Responder rate: A responder is defined as a subject with a total improvement score(TIS) ≥ 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs).
次要结局
- Mean Total Improvement Score (TIS) - Up to Week 25
- Point estimates and 95% CI for mean difference (IgPro20 – placebo) in TIS - Up to Week 25
- Mean changes from Baseline in Manual Muscle Testing (MMT-8) - Up to Week 25
- Point estimates and 95% CI for mean change difference (IgPro20 – placebo) in MMT-8 - Up to Week 25
- Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score - Up to Week 25
- Point estimates and 95% CI for mean change difference (IgPro20 – placebo) - Up to Week 25
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% - Up to Week 25
- Percentage and 95% CI of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% - Up to Week 25
- Point estimates and 95% CI for the odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% - Up to Week 25
- Mean TIS - Week 5 up to Week 53
- Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points - Week 5 up to Week 53
- Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS - Week 5 up to Week 53
- Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2 - Up to Week 53
- Mean changes in individual CSMs (except muscle enzymes) and CDASI from Baseline - Between Week 5 and Week 25
- Mean changes in individual CSMs (except muscle enzymes) and CDASI from Week 25 - Week 29 to Week 53
- Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice - Baseline up to Week 53
- Percentage of subjects meeting DOW at least once, twice, or > twice - Baseline up to Week 53
- Time to meeting DOW for the first time - Baseline up to Week 53
- Number of subjects meeting DOW and receiving rescue corticosteroid treatment - Baseline up to Week 53
- Percentage of subjects meeting DOW and receiving rescue corticosteroid treatment - Baseline up to Week 53
- Number of subjects who start oral corticosteroid dose taper - Baseline up to Week 53
- Percentage of subjects who start oral corticosteroid dose taper - Baseline up to Week 53
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% - Baseline up to Week 25
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% - Baseline up to Week 53
- Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% - Baseline up to Week 25
- Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% - Baseline up to Week 53
- Percentage of subjects receiving rescue corticosteroid treatment - Baseline up to Week 25
- Percentage of subjects whose rescue corticosteroid treatment is tapered - Baseline up to Week 25
- Time to first intake of rescue corticosteroid treatment - Baseline up to Week 25
- Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L - Baseline up to Week 53
- Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L - Baseline up to Week 53
- Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L - Week 25 up to Week 53
- Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L - Week 25 up to Week 53
- Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) - Up to 8 years
- Percentage of subjects with related TEAEs - Up to 8 years
- Percentage of subjects with serious TEAEs - Up to 8 years
- Rate of TEAEs per days with infusion - Up to 8 years
- Rate of TEAEs per days with infusion, by severity - Up to 8 years
- Rate of related TEAEs per days with infusion - Up to 8 years
- Rate of serious TEAEs per days with infusion - Up to 8 years
研究者
Trial Registration Coordinator
Scientific
CSL Behring LLC
研究点 (28)
Loading locations...
相似试验
进行中（未招募）
2 期
Phase II Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or AboveNCT07285278Suzhou Abogen Biosciences Co., Ltd.300
招募中
1 期
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.NCT07306754AbbVie66
进行中（未招募）
2 期
Phase II Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 50 Years or AboveNCT07289542Suzhou Abogen Biosciences Co., Ltd.420
尚未招募
1 期
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male VolunteersNCT07299955Biocon Biologics UK PLC150
进行中（未招募）
3 期
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49NCT07284654Vaxcyte, Inc.4,049