FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075029 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A follow-up study to test long-term treatment with BI 1015550 in people with pulmonary fibrosis who took part in a previous study with BI 1015550 
Scientific Title of Study   An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) 
Trial Acronym  FIBRONEERâ„¢-ON 
Secondary IDs if Any  
Secondary ID  Identifier 
1305-0031 version 2.0 dated 22 Sept 2023  Protocol Number 
2023-507353-15-00  EudraCT 
U1111-1295-8894  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Dahiya 
Designation  Team Lead - Speciality 
Affiliation  Boehringer Ingelheim India Pvt. Ltd 
Address  Vikhroli East, Kurla, Mumbai Suburban, Maharashtra, India

Mumbai
MAHARASHTRA
400079
India 
Phone  9920020494  
Fax    
Email  arun.dahiya@boehringer-ingelheim.com  
 
Details of Contact Person
Public Query
 
Name  Jinu Jose 
Designation  VP, RDS Sales and Clinical Operations, India 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli

Bangalore
KARNATAKA
560103
India 
Phone  9886203019  
Fax    
Email  jinu.jose@iqvia.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany 
 
Primary Sponsor  
Name  Boehringer Ingelheim 
Address  Middle East & North Africa (Scientific Office) FZ Limited, The Index Tower, Floor 13, Dubai International Financial Center, Dubai, United Arab Emirates 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDS INDIA PRIVATE LIMITED  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
New Zealand
Norway
Poland
Portugal
Republic of Korea
Saudi Arabia
Serbia
Singapore
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujeet Rajan  Bhatia Hospital  Ground Floor, G-I ward, Ground Floor, G-I ward, Tardeo Road
Mumbai
MAHARASHTRA 
022-66660020

skrajan@hotmail.com 
DrSrikanth Krishnamurthy  Hindusthan Hospital  Room 136 Nava India Road, 522/3, 523/3, Udayampalayam, Sowripalayam Pos Tamil Nadu, India
Coimbatore
TAMIL NADU 
9894257706

drsrikanthcbe@gmail.com 
Dr Zarir Udwadia  P.D. Hinduja Hospital & MRC  OPD building, wing No 1,Veer Sarvarkar Marg, Mahim
Mumbai
MAHARASHTRA 
9960584675

zfu@hindujahospital.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Bhatia Hospital Medical Research Society Ethics Committee_ Dr. Sujeet Rajan  Approved 
Institutional Human Ethics Committee_ Dr.Srikanth Krishnamurthy  Submittted/Under Review 
nstitutional Ethics Committee, P.D. Hinduja Hospital & MRC_ Dr. Zarir Udwadia  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Interventional agent: BI 1015550  Dose: b.i.d. Route: oral Duration: 98 weeks  
Comparator Agent  No comparator   No comparator 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) 1 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. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information. For France, fertile2 males must be ready and able to use acceptable methods of birth control. 
 
ExclusionCriteria 
Details  1. Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1
• any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
• any suicidal ideation of type 4 or 5 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
3. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
4. Patient will undergo lung transplantation, with an assigned date of surgery.
5. Patients with a BMI 10%) weight loss during the parent trial
6. At Visit 1, patients with ongoing AESI (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial
7. Patients who must or wish to take restricted medications (see Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial.
8. Patient not compliant in parent trial (1305-0014 or 1305-0023) with trial medication or trial visits, according to investigator’s judgement.
9. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant).
10. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
11. Previous enrolment in this trial.
12. Participation in another interventional study 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
primary objective of the trial is to descriptively assess the incidence of patients with any
adverse event. There will be no treatment comparison and the assessment will be while on treatment 
99 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
•Absolute change from baseline in FVC (mL) & in % predicted FVC over time  week 98 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="4" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a Phase III, multi-centre, multi-national, prospective, open-label extension clinical trial that will be conducted once the benefit-risk evaluation is shown to be positive in the pivotal Phase III program. Throughout this protocol, the precedent BI 1015550 Phase III trials (i.e. 1305-0014 and 1305-0023) are referred to as the parent trials. With approximately 2270 patients in total randomised into the parent trials, it is estimated that approximately 1700 patients with IPF/PPF will be eligible and participate in this extension trial (assuming discontinuation rate of ~25% over the whole of the parent trials and >90% of eligible patients agreeing to participate in this trial). Patients who prematurely discontinued trial medication permanently in the parent trials will not be eligible for this extension trial.

For each of the parent trials, all eligible patients can roll over into this extension trial at the end of the parent trial, without treatment interruption between the parent and extension trials, whenever possible. In the case where roll-over without interruption is not possible, eligible patients can start participation and treatment in the extension trial with a maximum interruption of 12 weeks between the respective parent trial and the open-label extension study.

All patients will receive open-label BI 1015550 at the dose (18 mg b.i.d. or 9 mg b.i.d.) that showed the most favourable benefit-risk in the pivotal Phase III clinical development. The treatment duration for each patient in this extension trial will not exceed 98 weeks. The trial will therefore end when the last patient has performed his/her end of study visit. Patients can discontinue trial participation early when BI 1015550 becomes commercially available to them 
Close