2024-518013-25-00招募中2 期
A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 104
- 主要终点
- Absolute change from baseline in forced vital capacity (mL) at Week 24.
研究概览
简要总结
To evaluate the safety, tolerability, and efficacy of investigational products as monotherapy or in combinations in adult subjects with Idiopathic Pulmonary Fibrosis (IPF).
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
- •Patients aged ≥ 40 years.
- •History of IPF diagnosis within 7 years of screening visit.
- •Confirmed diagnosis of IPF: a. Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest high-resolution Computed Tomography (HRCT) scan taken within 12 months of screening visit and, if available, (historical) surgical lung biopsy or transbronchical lung cryobiopsy, AND b. Usual Interstitial Pneumonia (UIP) or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to randomization visit. Patients with an "Indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" histopathology pattern. Subjects with an "Alternative diagnosis" HRCT finding are eligible if clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" histopathology pattern.
- •Either stable treatment with antifibrotics for at least 8 weeks prior to screening visit or not treated with antifibrotics for at least 4 weeks prior to screening visit.
- •FVC ≥ 45% of predicted normal at screening visit.
- •Percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) in a single breath ≥ 25% at screening visit.
排除标准
- •Relevant airways obstruction defined as pre-bronchodilator forced expiratory volume 1 second (FEV1)/FVC < 0.7 at screening visit.
- •Acute IPF exacerbation diagnosis within 4 months prior to screening and/or during the screening period (investigator determined).
- •Lower respiratory tract infection (e.g., infectious pneumonia, active tuberculosis) requiring antimicrobials within 4 weeks before screening visit and/or during the screening period.
研究组 & 干预措施
Placebo for ABBV-142
Placebo
干预措施: Placebo for ABBV-142 (Drug)
结局指标
主要结局
Absolute change from baseline in forced vital capacity (mL) at Week 24.
Absolute change from baseline in forced vital capacity (mL) at Week 24.
次要结局
- Absolute change from baseline in FVC (mL) at Week 52.
- Relative change from baseline in FVC (mL) at Week 24.
- Relative change from baseline in FVC (mL) at Week 52.
- Absolute and relative change from Baseline in FVC % predicted at Week 24.
- Absolute and relative change from Baseline in FVC % predicted at Week 52.
- Time to first ≥ 10% absolute decline in FVC% predicted.
- Time to first ≥ 5% absolute decline in FVC% predicted.
研究者
ABBVIE CALLCENTER
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (104)
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