A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 81
- 主要终点
- [Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
研究概览
简要总结
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age
- •Body mass index between 18.0 and 38.0 kg/m²
- •Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
- •Has diffuse cutaneous SSc, defined as mRSS >0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
- •Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years
- •mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive
- •FVC >50% predicted
- •Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)
排除标准
- •Has any of the following complications:
- •Left ventricular failure
- •Pulmonary arterial hypertension
- •Renal crisis within previous 6 months
- •Gastrointestinal dysmotility within previous 3 months
- •Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
- •Current rheumatic disease other than SSc that could interfere with assessment of SSc
- •Lung disease requiring continuous oxygen therapy
- •Evidence or suspicion of active or latent tuberculosis
- •Active Crohn's Disease or ulcerative colitis
研究组 & 干预措施
Placebo
Subcutaneous injection
干预措施: Tibulizumab (Biological)
Tibulizumab
Subcutaneous injection
干预措施: Tibulizumab (Biological)
Placebo
Subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
时间窗: Week 24
The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
[Period 2] Safety and tolerability of tibulizumab
时间窗: Week 52
Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results
次要结局
- [Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)(Week 24)
- [Period 1] Change from baseline in forced vital capacity (FVC) in participants with SSc-ILD(Week 24)
- [Period 1] Change from baseline in quantitative interstitial lung disease (QILD) obtained with high-resolution quantitative tomography (HRCT) in the whole lung in participants with SSc-interstitial lung disease (ILD)(Week 24)
- [Period 1] Safety and tolerability of tibulizumab(Week 24)
- [Period 2] Change from baseline in mRSS(Week 52)
- [Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD(Week 52)