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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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   
Address:  Binger Strasse 173 55216 Ingelheim am Rhein Germany
Telephone: 498002430127
Email: clintriage.rdg@boehringer-ingelheim.com
Affiliation:  Boehringer Ingelheim Pharma GmbH & Co. KG
Name: QRPE PSC CT Information Disclosure   
Address:  Binger Strasse 173 55216 Ingelheim am Rhein Germany
Telephone: 498002430127
Email: clintriage.rdg@boehringer-ingelheim.com
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
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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
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)
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: 1) 12 weeks
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 Outcome(s)
Timepoint(s) of evaluation of this end point: 1) 13 weeks
Secondary end point(s): 1) The percentage N (%) of patients with Treatment Emergent Adverse Events (TEAE).
Secondary ID(s)
2019-004167-45-FI
1305-0013
Source(s) of Monetary Support
Boehringer Ingelheim RCV GmbH & Co KG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 10/08/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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