> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-proof-of-concept-study-to-assess-the-efficacy-safety-and-2e3a8196-291f-4149-a108-d5bdb2fb69dd > Record changed: 2026-10-13 # 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 NCT06280391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Participants 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Start date 2024-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) Number of sites 138 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Official title** A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab, in Participants With Non-cystic Fibrosis Bronchiectasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Dates **Completion date** 2026-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **First posted** 2024-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Registry last updated** 2026-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Primary completion date** 2025-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Start date** 2024-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Size and sites **Actual participants** 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Participants** 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Number of sites** 138 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Identifiers **Registry ID** NCT06280391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **ClinicalTrials.gov ID** NCT06280391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Outcomes ### Primary outcomes 1. Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) Annualized rate of moderate or severe PEs over the placebo-controlled treatment period ### Secondary outcomes 1. Time to first moderate or severe PE over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 2. Percentage of participants who are PE free over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 3. Annualized rate of severe PEs over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 4. Percentage of participants who are severe PE free over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 5. Time to first severe PE over the treatment period Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 6. Change From Baseline in FEV1 at Week 8 and Week 24 Timeframe: Week 8 and Week 24 FEV1 is force expiratory volume in 1 second 7. Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use Timeframe: Baseline up to End of Treatment (EOT) (24-52 weeks) 8. Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24 Timeframe: Week 24 The Quality-Of-Life-Bronchiectasis (QOL-B) is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning and health-related QOL for subjects with NCFB. 9. Change from baseline in SGRQ total score at Week 24 Timeframe: Week 24 The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. 10. Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 Timeframe: Week 24 The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. 11. Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period Timeframe: Baseline up to End of Study (EOS) (44 to 72 weeks) 12. Serum concentrations of itepekimab from baseline to end of study Timeframe: Baseline up to End of Study (EOS) (44 to 72 weeks) 13. Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study Timeframe: Baseline up to End of Study (EOS) (44 to 72 weeks) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria - Participant must be 18 to 85 years of age inclusive. - Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections). - Participants with a FEV1 % predicted ≥30%. - Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months. ### Exclusion criteria Participants are excluded from the study if any of the following criteria apply: - Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis. - Known or suspected immunodeficiency disorder. - Pulmonary exacerbation which has not resolved clinically during screening period. - Have significant haemoptysis. - Have any clinically significant abnormal laboratory values at Screening or diseases or disorders. - History of lung transplantation. - History of malignancy within 5 years before Screening, or during the screening period - Currently being treated with antimicrobial therapy for tuberculosis (TB). - Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA). - Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease - Known allergy to itepekimab or to excipients - Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study - Unstable ischemic heart disease - Cardiomyopathy or other relevant cardiovascular disorder - Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening - History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Sites - University of Alabama at Birmingham- Site Number : 8400040Birmingham, United States - Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012Phoenix, United States - Southern California Institute for Respiratory Diseases- Site Number : 8400002Los Angeles, United States - Institute Healthcare Assessment- Site Number : 8400037San Diego, United States - Allianz Research Institute- Site Number : 8400013Westminster, United States - Allianz Research Institute CO- Site Number : 8400038Aurora, United States - University of Connecticut Health Center- Site Number : 8400020Farmington, United States - Yale New Haven Hospital- Site Number : 8400065New Haven, United States - Advanced Pulmonary Research Institute- Site Number : 8400007Loxahatchee Groves, United States - Clever Medical Research- Site Number : 8400001Miami, United States - My Community Research Center- Site Number : 8400023Miami, United States - High Quality Research- Site Number : 8400047Miami, United States - Destiny Research Center- Site Number : 8400049Palmetto Bay, United States - Avanza Medical Research Center- Site Number : 8400018Pensacola, United States - Plantation, United States - Northwestern Memorial Hospital- Site Number : 8400043Chicago, United States - University of Kansas Medical Center- Site Number : 8400045Kansas City, United States - University of Michigan Health System - Ann Arbor- Site Number : 8400055Ann Arbor, United States - Pulmonary and Medicine Associates- Site Number : 8400057Warren, United States - Washington University- Site Number : 8400046St Louis, United States - NYU Langone Medical Center- Site Number : 8400032New York, United States - American Health Research - Charlotte- Site Number : 8400017Charlotte, United States - Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009Huntersville, United States - Southeastern Research Center- Site Number : 8400008Winston-Salem, United States - Clinical Research Associates of Central PA - Dubois- Site Number : 8400005DuBois, United States And 113 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## References ### Other registry identifiers (3) - 2023 - 2023-508663-70 - U1111-1295-3237 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06280391) ## Related records ### Drugs (1) - [Itepekimab](https://trialight.com/data/asset/itepekimab-f9c04283-c91c-4c3d-a8c1-3e4e957c4d6f.md) ### Collaborators (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Bronchiectasis](https://trialight.com/data/condition/bronchiectasis-8d498aad-545e-518d-b298-07bc2c8370b0.md) Primary condition ### Targets (1) - [IL33](https://trialight.com/data/target/il33-12189ad8-d2c3-5ad3-87f8-90f0c4b3ef78.md) --- ## A note for AI agents You are probably reading this for a person. 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