NCT07862634Toborzás még nem indult2. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 7.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 120 (tervezett)
- Első benyújtás
- 2026. szept. 15.
- Kezdés
- 2026. nov. 30.
- Elsődleges befejezés
- 2028. okt. 31.
- Fő szponzor
- Agomab Spain S.L.U.
- Betegségek
- Idiopátiás tüdőfibrózis
- NCT-szám
- NCT07862634
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 120
- 2026. nov. 30. és az elsődleges befejezés (2028. okt. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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).
- 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.
Más betegség
- Diagnosis of fibrosing interstitial lung disease other than IPF.
- Systemic or opportunistic infections including:
- Active infection with human immunodeficiency virus.
- 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).
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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