protocolSection identificationModule nctId: NCT06317285, orgStudyIdInfo id: 220929, secondaryIdInfos id: 2023-509371-16-00, type: OTHER, domain: EU CTR, briefTitle: A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-19, completionDateStruct date: 2026-03-19, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: GSK3915393, interventions name: Placebo, outcomesModule primaryOutcomes measure: Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26, secondaryOutcomes measure: Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18, secondaryOutcomes measure: Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26, secondaryOutcomes measure: Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Vital Signs, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Electrocardiogram (ECG), secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Haematology, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Hepatobiliary Parameters, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Clinical Chemistry, secondaryOutcomes measure: Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants, secondaryOutcomes measure: Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393, secondaryOutcomes measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False