An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- primary objective of the trial is to descriptively assess the incidence of patients with any
研究概览
简要总结
This is a Phase III, multi-centre, multi-national, prospective, open-label extension clinical trial that will be conducted once the benefit-risk evaluation is shown to be positive in the pivotal Phase III program. Throughout this protocol, the precedent BI 1015550 Phase III trials (i.e. 1305-0014 and 1305-0023) are referred to as the parent trials. With approximately 2270 patients in total randomised into the parent trials, it is estimated that approximately 1700 patients with IPF/PPF will be eligible and participate in this extension trial (assuming discontinuation rate of ~25% over the whole of the parent trials and >90% of eligible patients agreeing to participate in this trial). Patients who prematurely discontinued trial medication permanently in the parent trials will not be eligible for this extension trial.
For each of the parent trials, all eligible patients can roll over into this extension trial at the end of the parent trial, without treatment interruption between the parent and extension trials, whenever possible. In the case where roll-over without interruption is not possible, eligible patients can start participation and treatment in the extension trial with a maximum interruption of 12 weeks between the respective parent trial and the open-label extension study.
All patients will receive open-label BI 1015550 at the dose (18 mg b.i.d. or 9 mg b.i.d.) that showed the most favourable benefit-risk in the pivotal Phase III clinical development. The treatment duration for each patient in this extension trial will not exceed 98 weeks. The trial will therefore end when the last patient has performed his/her end of study visit. Patients can discontinue trial participation early when BI 1015550 becomes commercially available to them
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- •Women of childbearing potential (WOCBP) 1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- •WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea.
- •A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information.
- •For France, fertile2 males must be ready and able to use acceptable methods of birth control.
排除标准
- •Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
- •Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1 • any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) • any suicidal ideation of type 4 or 5 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- •An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit
- •Patient will undergo lung transplantation, with an assigned date of surgery.
- •Patients with a BMI 10%) weight loss during the parent trial
- •At Visit 1, patients with ongoing AESI (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial
- •Patients who must or wish to take restricted medications (see Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial.
- •Patient not compliant in parent trial (1305-0014 or 1305-0023) with trial medication or trial visits, according to investigator’s judgement.
- •Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant).
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Previous enrolment in this trial.
- •Participation in another interventional study.
结局指标
主要结局
primary objective of the trial is to descriptively assess the incidence of patients with any
时间窗: 99 weeks
adverse event. There will be no treatment comparison and the assessment will be while on treatment
时间窗: 99 weeks
次要结局
- •Absolute change from baseline in FVC (mL) & in % predicted FVC over time(week 98)