Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT07862634
A Trial of AGMB-447 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing AGMB-447 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Agomab Spain S.L.U..
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- AGMB-447
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Confirmed pulmonary function criteria at screening, as follows:
- FVC ≥45% predicted of normal, as determined by spirometry,
- FEV1/FVC >0.7 or LLN, as determined by spirometry,
- Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥25% predicted of normal
- On standard of care for the treatment of IPF at a stable dose for at least 8 weeks before the screening visit, and during the screening period; or not on antifibrotic treatment and stable for at least 4 weeks before the screening visit (naïve or intolerant).
- Women of non childbearing potential (WONCBP) or male participants willing to comply with this protocol's requirements regarding contraception.
Who cannot join
- 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).
- Systemic or opportunistic infections including:
- Active infection with human immunodeficiency virus.
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- Known current tuberculosis infection.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).
- Chronic HCV (positive hepatitis C virus antibody [HCVAb] and hepatitis C virus [HCV] RNA).
- Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
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.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, multicenter Phase 2a trial to assess efficacy, safety, tolerability and pharmacokinetics (PK) of AGMB-447 compared to placebo in participants diagnosed with IPF over 24 weeks of treatment. The trial population will include adult participants aged ≥40 years with a confirmed diagnosis of IPF.
Approximately 120 eligible participants will be randomized in a 2:1 ratio to AGMB-447 or placebo group. Both AGMB-447 and placebo will be administered via inhalation.
The total duration of the trial for each participant will be up to approximately 32 weeks, consisting of a 4-week screening period, a 24-week treatment period, and a 4-week follow-up period.
After written informed consent is obtained, participants will enter a screening period of up to 28 days to assess eligibility.
Participants on an approved antifibrotic treatment should be on a stable dose for at least 8 weeks before the screening visit and throughout the screening period; or participants who are not on antifibrotic treatment should be stable for at least 4 weeks before the screening visit (treatment-naïve or intolerant).
At the end of the Treatment period, participants will enter a 4-week Follow-up period. The last trial visit (End of Study) for all participants will be on site, at the end of the Follow-up period.
Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessments, electrocardiogram (ECG), and recording of AEs.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- AGMB-447, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGMB-447Drug
Administered via inhalation
PlaceboDrug
Matching placebo administered via inhalation
| Study group | Role | What they receive |
|---|---|---|
| AGMB-447 | Experimental | Not described Receives: Drug: AGMB-447 |
| Placebo | Experimental | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Vital Capacity (FVC) (mL)
To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo
Measured: At week 24 compared to baseline (Day 1)
Secondary outcomes (8)
Concentration of AGMB-447 and MET-093 metabolite in plasma
To characterize the systemic PK of AGMB-447 in participants with IPF
Measured: From baseline to week 24
Incidence of Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From baseline to week 24
Number of participants with abnormal clinical laboratory tests
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From baseline to week 24
Number of participants with abnormal ECG parameters
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From baseline to week 24
Number of participants with abnormal vital signs
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From baseline to week 24
Number of participants with abnormal physical examinations
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From baseline to week 24
Change in forced expiratory volume in 1 second (FEV1)
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From pre-dose to week 24
Change in forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)
To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo
Measured: From pre-dose to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Tetzlaff, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862634
- Sponsor's protocol ID
- AGMB447-01-CL-201
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No