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American Health Research | Clinical Research of Charlotte

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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

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Sanofi

Status and phase

Enrolling
Phase 2

Conditions

Bronchiectasis

Treatments

Drug: Placebo
Drug: Itepekimab (SAR440340)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06280391
ACT18018
U1111-1295-3237 (Registry Identifier)
2023-508663-70 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

300 participants in 3 patient groups, including a placebo group

Itepekimab Q2W
Experimental group
Description:
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Treatment:
Drug: Itepekimab (SAR440340)
Itepekimab Q4W
Experimental group
Description:
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
Treatment:
Drug: Itepekimab (SAR440340)
Drug: Placebo
Placebo
Placebo Comparator group
Description:
SC administration of matching placebo Q2W for up to 52 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

125

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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