| 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 |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
|
| Email |
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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 |
|
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Source of Monetary or Material Support
|
| Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany |
|
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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 |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDS INDIA PRIVATE LIMITED |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103 |
|
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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 |
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, |
|
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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 |
|
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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 |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Open Label |
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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 |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 |