2022-500332-11-00招募中2 期
A Phase II, randomised, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG68 个研究点 分布在 12 个国家目标入组 68 人开始时间: 2022年11月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 68
- 主要终点
- Rate of decline (mL) in forced vital capacity (FVC) over 48 weeks
研究概览
简要总结
The primary objective is to assess superiority of BI 685509 over placebo based on the mean difference in annual rate of decline in FVC over 48 weeks. The treatment effect of primary interest will be based on all randomised patients including the effects of any changes of treatment, i.e., a treatment policy strategy will be used.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. UK ≥16 years).
- •Patients must fulfil the 2013 ACR/EULAR classification criteria for SSc.
- •Patients must be diagnosed with limited or diffuse cutaneous SSc as defined by LeRoy et al. Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive.
- •Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) must be within 7 years of Visit
- •Limited cutaneous SSc onset must be within 2 years of Visit 1
- •Evidence of active disease, defined as having at least one of the following: - New onset of SSc within the last 2 years of Visit 1 OR - New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the 17 body areas defined by mRSS assessment, documented in clinical files) OR - New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR - Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1 OR - ≥1 tendon friction rub.
- •Elevated biomarkers on Visit 1 (screening) defined as at least one of the following: - CRP ≥6 mg/L (≥0.6 mg/dL), OR - Erythrocyte sedimentation rate (ESR) ≥28 mm/h, OR - KL-6 ≥1000 U/mL. --> If none of the three criteria are met or should not be available, the patient can be entered if the mDAI is ≥ 2.
- •Evidence of significant vasculopathy, defined as: - Active DU(s) on Visit 1 OR - Documented history of DU(s), OR - Previous treatment of RP with prostacyclin analogues or ≥ 1 other medications, including calcium channel blockers, nitrates, NO donors in any form, including topical; phosphodiesterase 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); nonspecific PDE5 inhibitors (theophylline, dipyridamole) OR - RP with elevated CRP ≥6 mg/L --> If none of the four criteria above are met, the patient can be entered if the diagnosis of ILD has been confirmed
- •Further inclusion criteria apply.
排除标准
- •Any known form of pulmonary hypertension.
- •Pulmonary disease with FVC <50% of predicted at screening.
- •Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
- •Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
- •Any history of scleroderma renal crisis within the last 6 months.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI formula) or on dialysis at screening.
- •Cirrhosis of any Child-Pugh class (A, B or C)
- •Cholestasis at present, or ALP > 4 x ULN, or ALP > 2 x ULN and GGT > 3 x ULN at screening.
- •Further criteria apply.
结局指标
主要结局
Rate of decline (mL) in forced vital capacity (FVC) over 48 weeks
Rate of decline (mL) in forced vital capacity (FVC) over 48 weeks
次要结局
- Key secondary endpoint: Absolute change from baseline in mRSS at Week 48 in study participants with dcSSc
- Key secondary endpoint: Proportion of responders in study participants with dcSSc based on the revised CRISS at Week 48 (Achievement of ≥ 20% improvement from baseline to Week 48 in at least 3 of the 5 core set measures, except ≥ 5% in FVC percent predicted
- Key secondary endpoint: Absolute change from baseline in HAQ-DI score at Week 48
- ACR-CRISS score at Week 48 in study participants with dcSSc
- Absolute change from baseline in FVC (mL) at Week 48
- Absolute change from baseline in FVC (% predicted) at Week 48
- Absolute change from baseline in the PGA VAS score at Week 48
- Absolute change from baseline in the CGA VAS score at Week 48
- Composite measure of RP activity at Week 48
- Absolute change from baseline in DU net burden at Week 48
- Time to treatment failure, defined as the time to one of the following events (whichever occurs first) occurring over the 48-week and extended treatment period: - death, - absolute decline in percent-predicted FVC ≥10% relative to baseline, - ≥25% increase in mRSS and an increase in mRSS of >5 points, - initiation or dose change of immunomodulating/immunosuppressive therapy for clinically significant deterioration of SSc
- Time to mRSS progression (≥25% increase in mRSS and an increase in mRSS of >5 points) in study participants with dcSSc
- Proportion of study participants with dcSSc with mRSS progression (25% increase in mRSS and an increase in mRSS of >5 points)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (68)
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