BridgeMD
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
EU CTIS ID: 2023-507353-15-00
What this study is testing
The main objective is to assess the long-term tolerability, safety, and efficacy of oral nerandomilast treatment in patients with IPF and other types of PPF who have completed planned treatment (and did not prematurely discontinue trial medication permanently in the pivotal Phase III parent trials, 1305-0014 [FIBRONEER™-IPF] and 1305-0023 [FIBRONEER™-ILD]), and phase IIa 1305-0035. The 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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential (WOCBP) 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, fertile males must be ready and able to use acceptable methods of birth control
You likely can't join if
- Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
- 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)
- Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore >14 at Visit 1.
- 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.
- Patient will undergo lung transplantation, with an assigned date of surgery.
- Patients with a BMI <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
See the full eligibility criteria
- Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential (WOCBP) 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, fertile males must be ready and able to use acceptable methods of birth control
- Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
- 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)
- Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore >14 at Visit 1.
- 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.
- Patient will undergo lung transplantation, with an assigned date of surgery.
- Patients with a BMI <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
- At Visit 1, patients with ongoing AESI except for latent tuberculosis (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial
- Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Turkey
- Korea, Republic of
- Japan
- Canada
- Switzerland
- South Africa
- Chile
- New Zealand
- Australia
- Singapore
- China
- Malaysia
- Taiwan
- Saudi Arabia
- United Kingdom
- Argentina
- Mexico
- United States
- Israel
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Turkey; Korea, Republic of; Japan; Canada; Switzerland and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.