Phase 2Not yet recruitingAge-related condition
A Trial of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis
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
- Sponsor
- Agomab Spain S.L.U. (Industry)
- Enrolment
- 120 planned
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Interventions
- AGMB-447; Placebo
- Ages
- adults, older adults
- Registry
- NCT07862634
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in Forced Vital Capacity (FVC) (mL)
History
Study completion expected
Primary completion expected
Expected to start
Registered