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

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

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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