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A Trial of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis
Sponsor: Agomab Spain S.L.U.
Summary
The main goal of this clinical trial is to find out if an experimental inhaled drug, AGMB-447, can help improve lung function in people living with a lung disease called idiopathic pulmonary fibrosis (IPF). To do this, the effects of the study drug will be compared to a placebo, which is a treatment that looks like the study drug but contains no active medicine. The specific goals of the trial are as follows: Primary Objective and Estimand: The main goal is to see if 24 weeks of treatment with AGMB-447 helps the lungs work better than a placebo. This is measured by checking the total amount of air a person can forcefully blow out after taking a deep breath. The study will measure this effect for all participants who start the trial, regardless of whether they are able to finish the full 24 weeks of treatment or if they need to change their other medications during the study. Secondary Objective: The trial also aims to measure how much of the study drug is in the blood at different times. This helps researchers understand how the drug is absorbed and processed by the body after it is inhaled. In addition, the trial aims to evaluate if the treatment is safe and well-tolerated.
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Assess the Efficacy, Safety, and Tolerability of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-11-30
Completion Date
2028-12-31
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
AGMB-447
Administered via inhalation
Placebo
Matching placebo administered via inhalation