A Phase 2 trial of AGMB-447 in participants with idiopathic pulmonary fibrosis
Key facts
- Where
- Angers, Bobigny, Bron, Caen, Grenoble Cedex 9, Le Kremlin Bicetre Cedex, Lille, Marseille, Paris Cedex 18, Pessac, Rennes, Saint-Herblain, Suresnes, Toulouse és Tours Cedex 9, FranciaországSee the 15 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Regional D'AngersAngers, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisBobigny, FranciaországToborzás még nem indult
- Hospices Civils de LyonBron, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de Caen NormandieCaen, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországToborzás még nem indult
- Bicetre HospitalLe Kremlin Bicetre Cedex, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de LilleLille, FranciaországToborzás még nem indult
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de RennesRennes, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranciaországToborzás még nem indult
- Hospital FochSuresnes, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországToborzás még nem indult
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Agomab Spain S.L.U.
- Trial code
- EU 2026-526404-71-00
- Record updated
- 2026. november 4.
- Original description
To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo.Read full original descriptionShow less
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
To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo.
Inclusion: Participant 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 HRCT of the chest; Confirmed pulmonary function criteria at screening, as follows: a. FVC ≥45% predicted of normal, as determined by spirometry, b. FEV1/FVC >0.7 or lower limit or normal, as determined by spirometry, c. 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 or male participants willing to comply with this protocol's requirements regarding contraception.
Exclusion: 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; Diagnosis of fibrosing interstitial lung disease (ILD) other than IPF; Systemic or opportunistic infections including: a. Active infection with human immunodeficiency virus. b. Known current tuberculosis infection. c. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). d. Chronic HCV (positive hepatitis C virus antibody [HCVAb] and hepatitis C virus [HCV] RNA).