A follow-up study to test long-term treatment with BI 1015550 in people with pulmonary fibrosis who took part in a previous study with BI 1015550

JRCT ID: jRCT2021240008

Registered date:07/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
• Date of first enrollment: 26/09/2024
• Target sample size: 200
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Ezypt,Japan,Estonia,Japan,Finland,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,NewZealand,Japan,Norway,Japan,Poland,Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Primary endpoint of this trial is whether a patient had any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at week 99.

Secondary Outcome

Secondary endpoints of this trial are:
Absolute change from baseline in FVC (mL) and in % predicted FVC over time
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
Time to first acute IPF/PPF exacerbation or death over the duration of the trial
Time to hospitalisation for respiratory cause or death over the duration of the trial
Time to absolute decline in FVC % predicted of more than10% from baseline or death over the duration of the trial
Time to relative decline in FVC % predicted of more than 10% from baseline or death over the duration of the trial

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with IPF who have completed 1305-0014 trial on blinded treatment and patients with PPF who have completed 1305-0023 trial on blinded treatment (i.e. who did not prematurely discontinue trial treatment permanently in parent trials) and do not have any contraindication to treatment with BI 1015550
• Exclude criteria: Patients with IPF who have completed 1305-0014 trial on blinded treatment and patients with PPF who have completed 1305-0023 trial on blinded treatment (i.e. who did not prematurely discontinue trial treatment permanently in parent trials) and do not have any contraindication to treatment with BI 1015550

Related Information

• Primary Sponsor: Igarashi Haruki
• Secondary ID(s): NCT06238622