EUCTR2022-001134-11-GR进行中（未招募）1 期
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) - PDE4 Phase III trial in PF-ILD (Fibroneer- ILD)
Boehringer Ingelheim B.V0 个研究点目标入组 1,041 人开始时间: 2022年11月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,041
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients =18 years old at the time of signed informed consent.
- •2. Signed and dated written informed consent in accordance with ICH-GCP and local
- •legislation prior to admission to the trial.
- •3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed;
- •Section 3.3.1)
- •4. Patients may be either:
- •-- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. *stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks.
- •-- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either AF-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
- •5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1.
- •6. DLCO corrected for Hemoglobin (Hb) [Visit 1] =25% predicted of
- •normal at Visit 1.
- •7. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
- •8. Patients treated with permitted immunosuppressive agents (other
- •than corticosteroids) for an underlying systemic disease (e.g. MTX, AZA) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 441
排除标准
- •1. Prebronchodilator FEV1/FVC <0.7 at Visit 1
- •2. In the opinion of the Investigator, other clinically significant
- •pulmonary abnormalities.
- •3. Acute ILD exacerbation within 3 months prior to Visit 1 and/or during
- •the screening period (investigator-determined).
- •4. Relevant chronic or acute infections including human
- •immunodeficiency virus (HIV) and viral hepatitis.
- •5. Patients having developed ILD due to SARS-CoV-2 infection/COVID-19
- •within 12 months of screening (based on investigators judgement).
- •6. Major surgery (major according to the investigator's assessment)
- •performed within
- •6 weeks prior to Visit 2 or planned during the trial period, e.g. hip
- •replacement. Registration on lung transplantation list would not be
- •considered as planned major surgery.
- •7. Any documented active or suspected malignancy or history of
- •malignancy within 5 years prior to Visit 1, except appropriately treated
- •basal cell carcinoma of the skin, in situ squamous cell carcinoma of the
- •skin or in situ carcinoma of uterine cervix.
- •8. AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1.
- •9. eGFR =30 mL/min/1.73 m2 at Visit 1. (Chronic Kidney Disease
- •Epidemiology Collaboration [CKD-EPI] formula or Japanese version of
- •CKD-EPI for Japanese patients)
- •10. Patients with underlying liver disease (Child Pugh A, B, or C hepatic
- •impairment).
- •11. Cardiovascular diseases, any of the following:
- •a. Severe hypertension (uncontrolled under treatment =160/100 mmHg
- •at multiple occasions) within 3 months of Visit 1
- •b. Myocardial infarction, stroke or transient ischemic attack within 6
- •months of Visit 1
- •c. Unstable cardiac angina within 6 months of Visit 1
- •12. Use of any of the following medications: prednisone >15mg/day or
- •equivalent within 4 weeks of Visit 1; cyclophosphamide, tocilizumab,
- •mycophenolate, pirfenidone within 8 weeks of Visit 1; rituximab within 6
- •months of Visit 1.
- •Further criteria apply.
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