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History of Changes for Study: NCT05321082
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Latest version (submitted May 13, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 4, 2022 None (earliest Version on record)
2 April 21, 2022 Study Status
3 May 4, 2022 Study Status
4 May 30, 2022 Study Status
5 June 20, 2022 Study Status
6 July 19, 2022 Outcome Measures, Arms and Interventions, Study Description, Study Status, Study Identification, Eligibility and Study Design
7 July 27, 2022 Study Status
8 August 23, 2022 Study Status
9 September 7, 2022 Study Status
10 October 4, 2022 Study Status and Study Identification
11 October 6, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
12 October 21, 2022 Contacts/Locations and Study Status
13 November 1, 2022 Contacts/Locations and Study Status
14 November 14, 2022 Study Status and Contacts/Locations
15 November 28, 2022 Contacts/Locations and Study Status
16 December 13, 2022 Study Status and Contacts/Locations
17 December 28, 2022 Contacts/Locations and Study Status
18 January 10, 2023 Contacts/Locations and Study Status
19 January 23, 2023 Contacts/Locations and Study Status
20 February 6, 2023 Study Status and Contacts/Locations
21 February 25, 2023 Contacts/Locations and Study Status
22 March 8, 2023 Contacts/Locations and Study Status
23 March 20, 2023 Contacts/Locations and Study Status
24 April 3, 2023 Contacts/Locations and Study Status
25 April 17, 2023 Contacts/Locations and Study Status
26 May 2, 2023 Contacts/Locations and Study Status
27 May 27, 2023 Contacts/Locations, Eligibility and Study Status
28 June 12, 2023 Contacts/Locations and Study Status
29 June 26, 2023 Contacts/Locations and Study Status
30 July 11, 2023 Study Status and Contacts/Locations
31 July 25, 2023 Contacts/Locations and Study Status
32 August 7, 2023 Contacts/Locations and Study Status
33 August 22, 2023 Contacts/Locations and Study Status
34 September 7, 2023 Contacts/Locations and Study Status
35 September 22, 2023 Contacts/Locations and Study Status
36 October 30, 2023 Contacts/Locations and Study Status
37 November 16, 2023 Contacts/Locations and Study Status
38 November 28, 2023 Contacts/Locations and Study Status
39 December 12, 2023 Contacts/Locations and Study Status
40 January 10, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
41 January 23, 2024 Contacts/Locations and Study Status
42 February 6, 2024 Contacts/Locations and Study Status
43 February 22, 2024 Contacts/Locations and Study Status
44 March 6, 2024 Study Status and Contacts/Locations
45 March 25, 2024 Study Status
46 April 10, 2024 Contacts/Locations and Study Status
47 April 15, 2024 Contacts/Locations and Study Status
48 April 19, 2024 Arms and Interventions and Study Status
49 April 29, 2024 Study Status
50 May 13, 2024 Study Status and Contacts/Locations
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Study NCT05321082
Submitted Date:  April 4, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1305-0023
Brief Title: A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Official Title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Not yet recruiting
Study Start: August 17, 2022
Primary Completion: March 15, 2025 [Anticipated]
Study Completion: March 28, 2025 [Anticipated]
First Submitted: April 4, 2022
First Submitted that
Met QC Criteria:
April 4, 2022
First Posted: April 11, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 4, 2022
Last Update Posted: April 11, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

This study is open to adults with Progressive Fibrosing Interstitial Lung Disease (PF-ILD). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib or pirfenidone, they can continue treatment throughout the study.

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD.

Participants are put into 2 groups randomly, which means by chance. One group takes BI 1015550 tablets twice a day. The other group takes placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups.

The doctors also regularly check participants' health and take note of any unwanted effects.

Detailed Description: This record is disclosed early. Changes are expected in the final protocol after meetings with authorities. The record will be updated accordingly.
Open or close this module Conditions
Conditions: Lung Diseases, Interstitial
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 694 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BI 1015550 - Treatment Drug: BI 1015550
BI 1015550
Placebo Comparator: Placebo Drug: Placebo
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52
[ Time Frame: at baseline, at week 52 ]

Secondary Outcome Measures:
1. Key secondary endpoint: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score at Week 52
[ Time Frame: at baseline, at week 52 ]

The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items).

The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score.

Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.

2. Key secondary endpoint: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score at Week 52
[ Time Frame: at baseline, at week 52 ]

The L-PF is a 44-item questionnaire divided into two modules: Symptoms (23 items) and Impacts (21 items).

The Symptoms module assesses shortness of breath, cough and fatigue in the past 24 hours.

Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.

3. Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the whole trial
[ Time Frame: up to 32 months ]

4. Time to hospitalization for respiratory cause or death over the whole trial
[ Time Frame: up to 32 months ]

5. Time to 10% absolute FVC drop from baseline or death over the whole trial
[ Time Frame: up to 32 months ]

6. Time to death over the whole trial
[ Time Frame: up to 32 months ]

7. Time to first acute ILD exacerbation over the whole trial
[ Time Frame: up to 32 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the study (and prior to any study procedure including shipment of high-resolution computed tomography (HRCT) to reviewer).
  2. Patients (male/female), aged ≥ 18 years when signing the informed consent, with a physician diagnosed progressive fibrosing Interstitial Lung Disease (PF-ILD) other than Idiopathic Pulmonary Fibrosis (IPF) (presence of reticular abnormality with traction bronchiectasis with or without honeycombing on HRCT, performed within 12 months of Visit 1) AND who fulfil at least one of the following criteria for PF-ILD within 24 months of Visit 1 despite management according to current clinical practice to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):
    1. Clinically significant decline in Forced Vital Capacity (FVC) % predicted (pred) based on a relative decline of ≥10%
    2. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined with worsening of respiratory symptoms
    3. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined with increasing extent of fibrotic changes on chest imaging
    4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
  3. Patients need to be either

    -- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed.

    [*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks] OR

    -- not on a therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 or during the screening period. (e.g. either antifibrotic (AF)-treatment naïve or previously discontinued) and start or re-start of an antifibrotic is not planned.

  4. Patients treated with permitted immunosuppressive agents for the underlying disease (e.g. Mycophenolat-Mofetil (MMF), methotrexat (MTX), azathioprine (AZA) …) need to be on a stable treatment for at least 12 weeks prior to visit 1 and during screening period:

    For oral corticosteroids, the dose should not have been > 20 mg prednisolone/day (or equivalent) within 4 weeks prior to visit 1 For patients with underlying Connective Tissue Disease (CTD), the CTD should be stable, defined as no initiation of new therapy or withdrawal of therapy for CTD within 12 weeks prior to Visit 1 and during the screening period.

  5. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1
  6. Diffusing capacity for carbon monoxide (DLCO) corrected for Haemoglobin (Hb) [visit 1] ≥ 25% and <90% predicted of normal at Visit 1
  7. Female and male patients: Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information

Key exclusion criteria

  1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume (FEV)1/FVC < 0.7) at Visit 1.
  2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  3. Acute IPF or Interstitial Lung Disease (ILD) exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
  4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
  5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis and a confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the 4 weeks prior to Visit 1 or during the screening period.

    A patient can be re-screened if the patient was treated and/or cured from the acute infection.,

  6. 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.
  7. 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.
  8. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) > 2.5 x upper limit of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.

Further exclusion criteria apply.

Open or close this module Contacts/Locations
Central Contact Person: Boehringer Ingelheim
Telephone: 1-800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria:
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
URL: https://www.mystudywindow.com/msw/datasharing
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services