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
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Phase
Phase 2
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Recruitment status
Completed
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Participants
312
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Lead sponsor
Sanofi
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Start date
2024-02-20
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Number of sites
138
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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.
clinicaltrials.gov
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
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-02-02
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First posted
2024-02-28
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Registry last updated
2026-02-12
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Primary completion date
2025-09-16
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Start date
2024-02-20
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Actual participants
312
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Participants
312
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
138
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06280391
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ClinicalTrials.gov ID
NCT06280391
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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.

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-508663-70
  • U1111-1295-3237
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)