[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659310":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":48,"studyPopulation":34,"armGroups":49,"interventions":60,"overallOfficials":68,"centralContacts":73,"locations":34,"responsibleParty":79,"collaborators":34,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":34,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":34,"enrollmentInfo":90,"targetDuration":34,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":34,"overallStatus":99,"whyStopped":34,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":34},{"fullName":5,"class":6},"Agomab Therapeutics NV","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Forced Vital Capacity (FVC) (mL)","To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo","At week 24 compared to baseline (Day 1)",[14,18,21,23,25,27,29,32],{"measure":15,"description":16,"timeFrame":17},"Concentration of AGMB-447 and MET-093 metabolite in plasma","To characterize the systemic PK of AGMB-447 in participants with IPF","From baseline to week 24",{"measure":19,"description":20,"timeFrame":17},"Incidence of Treatment Emergent Adverse Events (TEAEs)","To evaluate the safety and tolerability of AGMB-447 in participants with IPF, compared to placebo",{"measure":22,"description":20,"timeFrame":17},"Number of participants with abnormal clinical laboratory tests",{"measure":24,"description":20,"timeFrame":17},"Number of participants with abnormal ECG parameters",{"measure":26,"description":20,"timeFrame":17},"Number of participants with abnormal vital signs",{"measure":28,"description":20,"timeFrame":17},"Number of participants with abnormal physical examinations",{"measure":30,"description":20,"timeFrame":31},"Change in forced expiratory volume in 1 second (FEV1)","From pre-dose to week 24",{"measure":33,"description":20,"timeFrame":31},"Change in forced expiratory volume in 1 second (FEV1)\u002F forced vital capacity (FVC)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study","TREATMENT",{"masking":41,"maskingDescription":42,"whoMasked":43},"QUADRUPLE","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nApproximately 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.\n\nThe 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.\n\nAfter written informed consent is obtained, participants will enter a screening period of up to 28 days to assess eligibility.\n\nParticipants 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).\n\nAt 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.\n\nThroughout 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.",[50,55],{"label":51,"type":52,"description":34,"interventionNames":53},"AGMB-447","EXPERIMENTAL",[54],"Drug: AGMB-447",{"label":56,"type":52,"description":57,"interventionNames":58},"Placebo","Matching Placebo",[59],"Drug: Placebo",[61,65],{"type":62,"name":51,"description":63,"armGroupLabels":64,"otherNames":34},"DRUG","Administered via inhalation",[51],{"type":62,"name":56,"description":66,"armGroupLabels":67,"otherNames":34},"Matching placebo administered via inhalation",[56],[69],{"name":70,"affiliation":71,"role":72},"Kay Tetzlaff, MD","Agomab Therapeutics","STUDY_DIRECTOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":34,"email":78},"Agomab Clinical Operations","CONTACT","0032 3318 91 70","clinicalstudies@agomab.com",{"type":80,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100659310","phase-2-a-trial-of-agmb-447-in-participants-with-idiopathic-pulmonary-fibrosis-100659310",false,"NCT07862634","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","Inclusion Criteria:\n\n* Participants aged ≥40 years at the time of signing the ICF.\n* 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).\n* Confirmed pulmonary function criteria at screening, as follows:\n\n  1. FVC ≥45% predicted of normal, as determined by spirometry,\n  2. FEV1\u002FFVC \\>0.7 or LLN, as determined by spirometry,\n  3. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥25% predicted of normal\n* 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).\n* Women of non childbearing potential (WONCBP) or male participants willing to comply with this protocol's requirements regarding contraception.\n\nExclusion Criteria:\n\n* Diagnosis of fibrosing interstitial lung disease other than IPF.\n* Acute IPF exacerbation within 6 months prior to screening and\u002For during the screening period.\n* Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and\u002For during the screening period.\n* 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).\n* Systemic or opportunistic infections including:\n\n  1. Active infection with human immunodeficiency virus.\n  2. Known current tuberculosis infection.\n  3. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).\n  4. Chronic HCV (positive hepatitis C virus antibody \\[HCVAb\\] and hepatitis C virus \\[HCV\\] RNA).\n* 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.","ALL","40 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","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.\n\nThe specific goals of the trial are as follows:\n\nPrimary 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.\n\nSecondary 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.",[98],"Idiopathic Pulmonary Fibrosis (IPF)","NOT_YET_RECRUITING","2026-10-01",{"date":102,"type":103},"2026-10-07","ACTUAL",{"date":105,"type":92},"2026-11-30",{"date":107,"type":92},"2028-12-31",{"name":109,"class":6},"Agomab Spain S.L.U."]