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Anti-fibrotic agent
GSK3915393 for Pulmonary Fibrosis
Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
"This trial is testing a new medicine called GSK3915393 on people with Idiopathic Pulmonary Fibrosis (IPF) for the first time. The goal is to see if this medicine
Who is the study for?
This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF), diagnosed within the last 5 years, who have a certain level of lung function and are either on stable antifibrotic treatment or not taking it. They must be able to consent and meet specific weight and body mass index criteria.
What is being tested?
The study tests GSK3915393's safety and effectiveness against IPF compared to a placebo. Participants will randomly receive either the new medicine or an inactive substance to see if there's an improvement in their lung condition.
What are the potential side effects?
As this is the first test of GSK3915393 in humans with IPF, potential side effects are unknown but may include typical drug reactions like nausea, headaches, allergic responses, or other unforeseen effects related to lung function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants will receive placebo.
Group II: GSK3915393Experimental Treatment1 Intervention
Participants will receive GSK3915393
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,420 Total Patients Enrolled
9 Trials studying Idiopathic Pulmonary Fibrosis
717 Patients Enrolled for Idiopathic Pulmonary Fibrosis
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,314 Total Patients Enrolled
5 Trials studying Idiopathic Pulmonary Fibrosis
109 Patients Enrolled for Idiopathic Pulmonary Fibrosis