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 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: ACT18018U1111-1295-32372023-508663-70
• Study Type: interventional
• Target: 312
• Locations: 20 countries
• Sites: 138

Brief 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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period

  Annualized rate of moderate or severe PEs over the placebo-controlled treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

Secondary Outcomes (13)

• Time to first moderate or severe PE over the treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

• Percentage of participants who are PE free over the treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

• Annualized rate of severe PEs over the treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

• Percentage of participants who are severe PE free over the treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

• Time to first severe PE over the treatment period

  Baseline up to End of Treatment (EOT) (24-52 weeks)

Study Arms (3)

Itepekimab Q2W

EXPERIMENTAL

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Drug: Itepekimab (SAR440340)

Itepekimab Q4W

EXPERIMENTAL

SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks

Drug: Itepekimab (SAR440340); Drug: Placebo

Placebo

PLACEBO COMPARATOR

SC administration of matching placebo Q2W for up to 52 weeks

Drug: Placebo

Interventions

Itepekimab (SAR440340) DRUG

Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Also known as: REGN3500

Itepekimab Q2W; Itepekimab Q4W

Placebo DRUG

Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Itepekimab Q4W; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (138)

University of Alabama at Birmingham- Site Number : 8400040

Birmingham, Alabama, 35233, United States

Location

Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012

Phoenix, Arizona, 85006, United States

Location

Southern California Institute for Respiratory Diseases- Site Number : 8400002

Los Angeles, California, 90048, United States

Location

Institute Healthcare Assessment- Site Number : 8400037

San Diego, California, 92120, United States

Location

Allianz Research Institute- Site Number : 8400013

Westminster, California, 92683, United States

Location

Allianz Research Institute CO- Site Number : 8400038

Aurora, Colorado, 80014, United States

Location

University of Connecticut Health Center- Site Number : 8400020

Farmington, Connecticut, 06032, United States

Location

Yale New Haven Hospital- Site Number : 8400065

New Haven, Connecticut, 06510, United States

Location

Advanced Pulmonary Research Institute- Site Number : 8400007

Loxahatchee Groves, Florida, 33470, United States

Location

Clever Medical Research- Site Number : 8400001

Miami, Florida, 33126, United States

Location

My Community Research Center- Site Number : 8400023

Miami, Florida, 33155, United States

Location

High Quality Research- Site Number : 8400047

Miami, Florida, 33184, United States

Location

Destiny Research Center- Site Number : 8400049

Palmetto Bay, Florida, 33157, United States

Location

Avanza Medical Research Center- Site Number : 8400018

Pensacola, Florida, 32503, United States

Location

Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010

Plantation, Florida, 33324, United States

Location

Northwestern Memorial Hospital- Site Number : 8400043

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center- Site Number : 8400045

Kansas City, Kansas, 66160, United States

Location

University of Michigan Health System - Ann Arbor- Site Number : 8400055

Ann Arbor, Michigan, 48109, United States

Location

Pulmonary and Medicine Associates- Site Number : 8400057

Warren, Michigan, 48088, United States

Location

Washington University- Site Number : 8400046

St Louis, Missouri, 63110, United States

Location

NYU Langone Medical Center- Site Number : 8400032

New York, New York, 10016, United States

Location

American Health Research - Charlotte- Site Number : 8400017

Charlotte, North Carolina, 28277, United States

Location

Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009

Huntersville, North Carolina, 28078, United States

Location

Southeastern Research Center- Site Number : 8400008

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Research Associates of Central PA - Dubois- Site Number : 8400005

DuBois, Pennsylvania, 15801, United States

Location

Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital- Site Number : 8400015

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027

Charleston, South Carolina, 29425, United States

Location

Metroplex Pulmonary and Sleep Center- Site Number : 8400014

McKinney, Texas, 75069, United States

Location

Plano Primary Care Clinic- Site Number : 8400019

Plano, Texas, 75024, United States

Location

Pioneer Research Solutions, Inc.- Site Number : 8400048

Sugar Land, Texas, 77479, United States

Location

The University of Texas Health Center at Tyler- Site Number : 8400053

Tyler, Texas, 75708, United States

Location

Investigational Site Number : 0320002

La Plata, Buenos Aires, 1900, Argentina

Location

Investigational Site Number : 0320003

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320008

Buenos Aires, 1280, Argentina

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Buenos Aires, 1414, Argentina

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Buenos Aires, 1427, Argentina

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Córdoba, 5003, Argentina

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Mendoza, 5500, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

Oncoclínicas UMC- Site Number : 0760007

Uberlândia, Minas Gerais, 38411-186, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760004

Porto Alegre, Rio Grande do Sul, 91010-006, Brazil

Location

Incor - Instituto do Coracao- Site Number : 0760002

São Paulo, 05403-900, Brazil

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Investigational Site Number : 1240003

Guelph, Ontario, N1H 6J2, Canada

Location

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Sherbrooke, Quebec, J1H 5N4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

Location

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Talca, Maule Region, 3465584, Chile

Location

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Santiago, Reg Metropolitana de Santiago, 7500587, Chile

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Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

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Quillota, Región de Valparaíso, 2260877, Chile

Location

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Beijing, 100020, China

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Changchun, 130021, China

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Chengdu, 610041, China

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Guangzhou, 510120, China

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Shanghai, 200025, China

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Shanghai, 200433, China

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Shenyang, 110004, China

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Xuzhou, 221006, China

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Český Krumlov, 381 01, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Pilsen, 305 99, Czechia

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Prague, 190 00, Czechia

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Aalborg, 9000, Denmark

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Aarhus, 8200, Denmark

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Odense, 5000, Denmark

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Vejle, 7100, Denmark

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Brest, 29200, France

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Lyon, 69004, France

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Montpellier, 34090, France

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Nice, 06001, France

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Paris, 75679, France

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Saint-Herblain, 44800, France

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Ahrensburg, 22926, Germany

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Bendorf, 56170, Germany

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Berlin, 12159, Germany

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Cottbus, 03050, Germany

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Essen, 45239, Germany

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Frankfurt, 60596, Germany

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Lübeck, 23552, Germany

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Mainz, 55128, Germany

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Munich, 80337, Germany

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Ioannina, 455 00, Greece

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Thessaloniki, 570 10, Greece

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Ashkelon, 7830604, Israel

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Haifa, 3436212, Israel

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Jerusalem, 9103102, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5262100, Israel

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Rehovot, 7610001, Israel

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Tel Aviv, 6423906, Israel

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Tel Aviv, 6789140, Israel

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Milan, Lombardy, 20122, Italy

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Rozzano, Milano, 20089, Italy

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Palermo, 90127, Italy

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Pavia, 27100, Italy

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Reggio Emilia, 42123, Italy

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Kamogawa, Chiba, 296-0041, Japan

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Himeji, Hyōgo, 670-0849, Japan

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Kiyose, Tokyo, 204-8522, Japan

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Tokyo, 140-8522, Japan

Location

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Tokyo, 162-8655, Japan

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Alkmaar, 1815 JD, Netherlands

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Breda, 4818 CK, Netherlands

Location

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Rotterdam, 3015 CE, Netherlands

Location

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The Hague, 2545 CH, Netherlands

Location

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Lodz, Lódzkie, 90-153, Poland

Location

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Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

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Lodz, 90-302, Poland

Location

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Wejherowo, 84-200, Poland

Location

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Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

Investigational Site Number : 7240007

Barcelona, Barcelona [Barcelona], 08017, Spain

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Barcelona, Barcelona [Barcelona], 08035, Spain

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Barcelona, Barcelona [Barcelona], 08036, Spain

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L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

Location

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Girona, Girona [Gerona], 17005, Spain

Location

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Madrid, Madrid, Comunidad de, 28007, Spain

Location

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Kaohsiung City, 807, Taiwan

Location

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New Taipei City, 220, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Taipei, 110, Taiwan

Location

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Adana, 01330, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Akdeniz, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Ankara, 06620, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

İzmit, 41001, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Samsun, 55139, Turkey (Türkiye)

Location

Investigational Site Number : 8260009

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Investigational Site Number : 8260008

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Investigational Site Number : 8260003

North Shields, North Tyneside, NE29 8NH, United Kingdom

Location

Investigational Site Number : 8260004

Lancaster, LA1 4RP, United Kingdom

Location

Investigational Site Number : 8260001

Newcastle upon Tyne, NE7 7DN, United Kingdom

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Investigational Site Number : 8260005

Reading, RG1 5AN, United Kingdom

Location

Related Links

• ACT18018 Plain Language Results Summary

MeSH Terms

Conditions

Bronchiectasis

Interventions

itepekimab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: February 20, 2024
• Primary Completion: September 16, 2025
• Study Completion: February 2, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); BR (5); GR (2); AR (8); CN (8); CL (4); CZ (5); DK (4); PL (5); US (32); IL (9); TU (6); CA (3); ES (6); TW (5); JP (5); GB (6); NL (5); FR (6); DE (9)