A Trial of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis
ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorAgomab Spain S.L.U.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged ≥40 years at the time of signing the ICF.
Diagnosis of IPF within 7 years prior to the screening visit, confirmed by centrally reviewed high-resolution computed tomography (HRCT) of the chest (performed during screening period).
FVC ≥45% predicted of normal, as determined by spirometry,
FEV1/FVC >0.7 or LLN, as determined by spirometry,
Disqualifiers
Diagnosis of fibrosing interstitial lung disease other than IPF.
Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
History of lung volume reduction surgery or lung transplant or major surgery performed within 3 months prior to baseline or planned during the trial (being on a transplant list is allowed).
Trial design
Design model
Parallel
Treatments tested in this trial
AGMB-447
DrugAdministered via inhalation
Placebo
DrugMatching placebo administered via inhalation
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: AGMB-447Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Forced Vital Capacity (FVC) (mL)
To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo
Time frame
At week 24 compared to baseline (Day 1)Secondary outcomes
1
Concentration of AGMB-447 and MET-093 metabolite in plasma
To characterize the systemic PK of AGMB-447 in participants with IPF
Time frame
From baseline to week 242
Incidence of Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Time frame
From baseline to week 243
Number of participants with abnormal clinical laboratory tests
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Time frame
From baseline to week 244
Number of participants with abnormal ECG parameters
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Time frame
From baseline to week 24Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: