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

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Registered