A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-001091-34-EE
• Lead Sponsor: Boehringer Ingelheim France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-08
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 963

Inclusion Criteria

Patients =40 years old at the time of signed consent
IPF diagnosis based on 2022 ATS/ERS/JRS/ALAT Guidelines
FVC =45% of predicted normal
DLCO =25% predicted of normal corrected for hemoglobin
On stable treatment with nintedanib or pirfenidone for at least
12 weeks or not on treatment with either nintedanib or
pirfenidone for at least 8 weeks
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 337
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 626

Exclusion Criteria

Prebronchodilator FEV1/FVC <0.7
Acute IPF exacerbation within 3 months and/or during the screening period
Treated with immunomodulatory medications (other than oral
corticosteroids) or prednisone >15 mg/day or equivalent for
respiratory or pulmonary reasons
Active, unstable or uncontrolled vasculitis within 8 weeks
Any suicidal behaviour in the past 2 years
Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified