臨床研究等提出・公開システム

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) (FIBRONEER-ON)

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 (FIBRONEER-ON)

Igarashi Haruki

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Shizuko Kawahara

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Sept. 26, 2024

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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

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

Both

pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)

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.

pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)

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 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

+81-24-946-0808

April. 05, 2024

Yes

Researchers can refer to boehringer-ingelheim's web site to request access to raw data from our clinical studies.

Argentina/Australia/Austria/Belgium/Brazil/Canada/Chile/China/Croatia/Czech Republic/Denmark/Ezypt/Estonia/Finland/France/Georgia/Germany/Greece/Hungary/India/Ireland/Israel/Italy/Korea/Malaysia/Mexico/Netherlands/NewZealand/Norway/Poland