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)

• Status: Completed
• Trial end date: 2020-02-19
• Target enrollment: 0
• Participant gender: All

Summary

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 are recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.

• Severe exacerbations are 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Cholinergic Agents; Muscarinic Agonists

Criteria

Inclusion criteria :

• 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] <70% and post-bronchodilator FEV1 % predicted <80%, but ≥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 patient in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] have been excluded).

• Participants with a documented history (eg. medical record verification) of ≥2 moderate exacerbations or ≥1 severe exacerbation within the year prior to screening. A moderate exacerbation is 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 is available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation is 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.

Exclusion criteria:

• Concomitant severe diseases or diseases for which the use of Inhaled Corticosteroids (ICS) (e.g., active pulmonary tuberculosis, etc.) or Long Acting Beta Agonists (LABA) are 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 IV 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 (>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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.