A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT04419506

Collaborator

(none)

147

Enrollment

Locations

Arms

14.6

Actual Duration (Months)

6.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study.

The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks.

After 1 month of treatment, they visit the study site every 4 weeks.

The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day.

The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: BI 1015550 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally

Actual Study Start Date :

Jul 28, 2020

Actual Primary Completion Date :

Oct 6, 2021

Actual Study Completion Date :

Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1015550	Drug: BI 1015550 film-coated tablet
Placebo Comparator: Placebo	Drug: Placebo film-coated tablet

Arm

Intervention/Treatment

Experimental: BI 1015550

Drug: BI 1015550

film-coated tablet

Placebo Comparator: Placebo

Drug: Placebo

film-coated tablet

Outcome Measures

Primary Outcome Measures

change from baseline in Forced Vital Capacity (FVC) [up to 12 weeks]

Secondary Outcome Measures

percentage of patients with Treatment Emergent Adverse Events (TEAE) [up to 13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged ≥40 years when signing the informed consent.
Diagnosis:
IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within 12 months of Visit 1 and if available surgical lung biopsy.

and

Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to Visit 2*

if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy

Stable for at least 8 weeks prior to Visit 1. Patients have to be either :

not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed), or
on stable* therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and planning to stay stable on this background therapy after randomisation.

[*stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib]

Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1.
In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
Major surgery (major according to the investigator's assessment) performed within 3 months prior to Visit 1 or planned during the course of the trial. (Being on a transplant list is allowed).
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, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2.
Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to Visit 1 and/or during the screening period.

Further exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610
2	Centro de Investigaciones Metabólicas (CINME)	C.a.b.a		Argentina	C1027AAP
3	The Alfred Hospital	Melbourne	Victoria	Australia	3004
4	LKH-Univ. Hospital Graz	Graz		Austria	8036
5	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario	Canada	N8X 1T3
6	Centro de Investigación del Maule	Talca		Chile	3465586
7	The Second Hospital of Jilin University	Changchun		China	130041
8	Thomayer Hospital	Praha 4 - Krc		Czechia	140 59
9	Aarhus University Hospital	Aarhus N		Denmark	8200
10	HYKS Keuhkosairauksien tutkimusyksikkö	Helsinki		Finland	00290
11	Fachkrankenhaus Coswig GmbH	Coswig		Germany	01640
12	University General Hospital of Heraklion	Crete		Greece	71110
13	Semmelweis University	Budapest		Hungary	1085
14	Policlinico Gemelli	Roma		Italy	00168
15	Tosei General Hospital	Aichi, Seto		Japan	489-8642
16	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon		Korea, Republic of	14647
17	Zuyderland Medisch Centrum	Heerlen		Netherlands	6419 PC
18	University Clinical Center, Gdansk	Gdansk		Poland	80-214
19	Moscow 1st State Med.Univ.n.a.I.M.Sechenov	Moscow		Russian Federation	119992
20	Hospital de Bellvitge	L'Hospitalet de Llobregat		Spain	08907
21	Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv	Kyiv		Ukraine	03680
22	Royal Brompton Hospital	London		United Kingdom	SW3 6NP

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04419506

Other Study ID Numbers:

1305-0013
2019-004167-45

First Posted:

Jun 5, 2020

Last Update Posted:

Nov 1, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Fibrosis

Study Results

No Results Posted as of Nov 1, 2021