A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).

• Register: EUCTR
• Last refreshed on: 29 November 2021
• Main ID: EUCTR2019-004167-45-HU
• Date of registration: 24/06/2020
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim RCV GmbH & Co KG
• Public title: A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).
• Scientific title: A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d.
• Date of first enrolment: 17/08/2020
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004167-45
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Canada, Chile, China, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Slovakia, Spain, United Kingdom, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients aged =40 years when signing the informed consent.
- Diagnosis:
-- a. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as confirmed by the investigator based on chest HRCT scan taken within 12 months of Visit 1 and if available surgical lung biopsy. and
-- b. UIP or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF
- 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.
- Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1
- 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.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
- Relevant airways obstruction (pre-bronchodilator FEV1/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 (see table 5.2.3 :1) 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).
- Confirmed infection with SARS-CoV-2 within 4 weeks prior to visit 1 or
during screening period.
- Further criteria apply.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BI 1015550
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BI 1015550
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 1) The primary endpoint is the change from baseline in FVC

Main Objective: - To investigate the efficacy of BI 1015550 compared to placebo based on the change
from baseline in Forced Vital Capacity (FVC).
- To investigate safety and tolerability of BI 1015550 in the overall trial population.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: 1) 12 weeks

Secondary Outcome(s)

Secondary end point(s): 1) The percentage N (%) of patients with Treatment Emergent Adverse Events (TEAE).

Timepoint(s) of evaluation of this end point: 1) 13 weeks

Secondary ID(s)

1305-0013

2019-004167-45-FI

Source(s) of Monetary Support

Boehringer Ingelheim RCV GmbH & Co KG

Ethics review

Status: Approved
Approval date: 10/08/2020
Contact: