NCT07862634

A Trial of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis

StatusNot Yet Recruiting

PhasePhase 2

SponsorAgomab Spain S.L.U.

Primary completionOct 31, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 1, 2026 Study First Submitted

Endpoints

Primary

Change in Forced Vital Capacity (FVC) (mL)

Timeframe: At week 24 compared to baseline (Day 1)

Secondary (8)

Concentration of AGMB-447 and MET-093 metabolite in plasma

Incidence of Treatment Emergent Adverse Events (TEAEs)

Number of participants with abnormal clinical laboratory tests

Number of participants with abnormal ECG parameters

Number of participants with abnormal vital signs

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Number of participants with abnormal physical examinations

Change in forced expiratory volume in 1 second (FEV1)

Change in forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)

Arms and interventions

AGMB-447Experimental

PlaceboExperimental

Matching Placebo

Drugs: AGMB-447, Placebo

About this trial

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.

Trial details

Enrollment: 120 participants (estimated)
Started: Nov 30, 2026
Study completion: Dec 31, 2028 (estimated)
Eligibility: 40 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee
Conditions: Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
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
First posted: Oct 7, 2026
Registry updated: Oct 7, 2026
Last verified: Oct 2026

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