protocolSection identificationModule nctId: NCT06280391, orgStudyIdInfo id: ACT18018, secondaryIdInfos id: U1111-1295-3237, type: REGISTRY, domain: ICTRP, secondaryIdInfos id: 2023-508663-70, type: REGISTRY, domain: CTIS, briefTitle: A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-03-24, completionDateStruct date: 2026-08-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).Study details include:* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.* The treatment duration will be up to 24-52 weeks.* The follow-up duration will be 20 weeks.* Site/phone visits are at a monthly interval., conditionsModule conditions: Bronchiectasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Itepekimab (SAR440340), interventions name: Placebo, outcomesModule primaryOutcomes measure: Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period, secondaryOutcomes measure: Time to first moderate or severe PE over the treatment period, secondaryOutcomes measure: Percentage of participants who are PE free over the treatment period, secondaryOutcomes measure: Annualized rate of severe PEs over the treatment period, secondaryOutcomes measure: Percentage of participants who are severe PE free over the treatment period, secondaryOutcomes measure: Time to first severe PE over the treatment period, secondaryOutcomes measure: Change From Baseline in FEV1 at Week 8 and Week 24, secondaryOutcomes measure: Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use, secondaryOutcomes measure: Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24, secondaryOutcomes measure: Change from baseline in SGRQ total score at Week 24, secondaryOutcomes measure: Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24, secondaryOutcomes measure: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period, secondaryOutcomes measure: Serum concentrations of itepekimab from baseline to end of study, secondaryOutcomes measure: Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Allianz Research Institute Site Number : 8400013, status: RECRUITING, city: Westminster, state: California, zip: 92683, country: United States, geoPoint lat: 33.75918, lon: -118.00673, locations facility: Southeastern Research Center Site Number : 8400008, status: RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Investigational Site Number : 8260008, status: RECRUITING, city: Norwich, state: Norfolk, zip: NR4 7UY, country: United Kingdom, geoPoint lat: 52.62783, lon: 1.29834, locations facility: Investigational Site Number : 8260003, status: RECRUITING, city: Tyne And Wear, state: North Tyneside, zip: NE29 8NH, country: United Kingdom, locations facility: Investigational Site Number : 8260001, status: RECRUITING, city: Newcastle upon Tyne, zip: NE7 7DN, country: United Kingdom, geoPoint lat: 54.97328, lon: -1.61396, locations facility: Investigational Site Number : 8260005, status: RECRUITING, city: Reading, zip: RG1 5AN, country: United Kingdom, geoPoint lat: 51.45625, lon: -0.97113, hasResults: False