Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 \[IL-33\] monoclonal antibody \[mAb\]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. * Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. * Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.

Key facts

Study ID

NCT03546907

Run by

Sanofi

People needed

343

Starts

2018-07-16

Expected to finish

2020-02-21

Last updated by the study team

2022-11-22

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
• Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1% predicted <80%, but greater than equal to [>=] 30%).
• Participants with COPD assessment test (CAT) score >=10 at Screening.
• Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a participant in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] had been excluded).
• Participants with a documented history (e.g., medical record verification) of >=2 moderate exacerbations or >=1 severe exacerbation within the year prior to screening. A moderate exacerbation was defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a "moderate exacerbation" unless documentation was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was defined as an AECOPD that required a hospitalization.
• Participants with standard of care background therapy, for 3 months and at a stable dose for at least 1 month, including either:
• Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.
• or
• Triple therapy: LABA + LAMA + ICS.
• Current or former smokers with a smoking history of >=10 packs/year.

You may not qualify if…

• Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia).
• Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within previous 1 month or more than 4 courses of intravenous glucocorticosteroids within the previous 6 months.
• Participants with bronchial thermoplasty procedure (up to 3 years prior to Visit 1).
• A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines.
• Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc.) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
• Diagnosis of α-1 anti-trypsin deficiency.
• Advanced COPD with need for chronic (greater than [>] 15 hours/day) oxygen support.
• Participant with a moderate or severe acute exacerbation of COPD event within previous 4 weeks.
• A participant who has experienced an upper or lower respiratory tract infection within previous 4 weeks.
• Prior history of or planned pneumonectomy or lung volume reduction surgery.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400003 — Riverside, California, United States
• Investigational Site Number 8400006 — Rolling Hills Estates, California, United States
• Investigational Site Number 8400015 — Westminster, California, United States
• Investigational Site Number 8400013 — Jacksonville, Florida, United States
• Investigational Site Number 8400012 — Columbia, Maryland, United States
• Investigational Site Number 8400016 — North Dartmouth, Massachusetts, United States
• Investigational Site Number 8400020 — South Dartmouth, Massachusetts, United States
• Investigational Site Number 8400011 — Minneapolis, Minnesota, United States
• Investigational Site Number 8400005 — Jamaica, New York, United States
• Investigational Site Number 8400019 — Chapel Hill, North Carolina, United States
• Investigational Site Number 8400004 — Raleigh, North Carolina, United States
• Investigational Site Number 8400001 — Medford, Oregon, United States
• Investigational Site Number 8400009 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 8400007 — Plano, Texas, United States
• Investigational Site Number 8400008 — Greenfield, Wisconsin, United States
• Investigational Site Number 0320001 — Buenos Aires, Argentina
• Investigational Site Number 0320005 — Caba, Argentina
• Investigational Site Number 0320002 — Caba, Argentina
• Investigational Site Number 0320004 — Caba, Argentina
• Investigational Site Number 0320006 — Quilmes, Argentina
• Investigational Site Number 0320003 — Rosario, Argentina
• Investigational Site Number 0360005 — Bedford Park, Australia
• Investigational Site Number 0360002 — Chermside, Australia
• Investigational Site Number 0360004 — Clayton, Australia
• Investigational Site Number 8400002 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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