BridgeMD
Phase 2 study to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)
EU CTIS ID: 2023-509371-16-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of GSK3915393, compared to placebo, on reducing the decline in lung volume in IPF participants.
- Therapeutic exploratory (Phase II)
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
- IPF diagnosed within 5 years prior to screening based on the applicable ATS/ERS/JRS/ALAT Guideline at the time of diagnosis.
- FVC ≥45% of predicted normal.
- Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
- If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
- If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or patient choice.
You likely can't join if
- ILD associated with other known causes.
- Acute IPF exacerbation within 6 months prior to screening and/or during the screening period
- Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, COVID-19) requiring treatment within 4 weeks prior to and/or during the screening period.
- Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- History of previous lung transplant or recent major surgery within 12 weeks prior to screening or planned during the trial period.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Korea, Republic of
- United States
- United Kingdom
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 Canada; Argentina; Korea, Republic of; United States; United Kingdom. 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.