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Clinical Trials List

Protocol NumberACT18018
Active

2024-05-31 - 2027-05-30

Phase II

Recruiting5

ICD-10J47.9

Bronchiectasis, uncomplicated

ICD-9494.0

Bronchiectasis without acute exacerbation

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

  • Trial Applicant

  • Sponsor

    Sanofi-Aventis Recherche & Développement

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 鄭世隆 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ping-Hung Kuo Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen Chia-Hung Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

non-cystic fibrosis bronchiectasis

Objectives

Primary • Evaluate the efficacy of itepekimab compared with placebo on occurrence of PEs in NCFB

Test Drug

injection

Active Ingredient

Itepekimab

Dosage Form

230

Dosage

300mg/ 2ml

Endpoints

Annualized rate of moderate or severe PEsa over
the treatment period

Inclution Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01. Participant must be 18 to 85 years of age inclusive, at the time of signing the informed
consent.
Type of participant and disease characteristics
I 02. Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent
respiratory infections) that is confirmed by chest computerized tomography (CT) scan
(either historically within the past 5 years, or during screening), AND are mucopurulent
sputum producers with a history of chronic expectoration.
I 03. Participants with a post-BD FEV1 % predicted ≥30% during Screening period (obtained in
between Visit 1 but prior to Baseline/Randomization Visit 2).
I 04. At least 2 moderate or 1 severe PEs defined by need for antibiotic prescription by
a physician for the signs and symptoms of respiratory infections in the past 12 month
before the Screening Visit. In case maintenance antibiotic is used, at least one exacerbation
must have occurred while patient was on maintenance antibiotic therapy.
- Moderate PE = worsened respiratory symptoms leading to treatment with antibiotics,
or addition of antibiotics, or change in antibiotics.
- Severe PE = worsened respiratory symptoms resulting in hospitalization or observation
for >24 hours in emergency department/urgent care facility.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01. Have bronchiectasis due to CF, hypogammaglobulinemia, common variable
immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or
pulmonary fibrosis.
E 02. Participants who are currently smoking tobacco, or participants in whom smoking
cessation has occurred <6 months prior to Screening (Visit 1) Note: Urine cotinine levels
will be tested at Screening (Visit 1) and at various subsequent visits during the study
(nicotine replacement therapy and/or non-inhaled tobacco product use are not considered
current smoking of tobacco).
E 03. Known or suspected immunodeficiency disorder, including history of invasive/systemic
opportunistic infections outside of the lungs.
E 04. Pulmonary exacerbation (PE) (as described in Section 8.2.1) which has not resolved
clinically during screening period. Screening period may be extended by 4 weeks to
a maximum duration of 9 weeks in case of an intercurrent PE.
E 05. Have significant haemoptysis (requiring medical intervention and/or requiring blood
transfusion) within 6 weeks prior to Baseline (Visit 2).
E 06. Have any clinically significant abnormal laboratory values at Screening (Visit 1) or
diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney,
neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment,)
that, in the opinion of the Investigator, may put the subject at risk by participating in the
study, or interfere with the subject’s treatment, assessment, or influence the results of the
study, or have compliance issues with the study.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    300 participants

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