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)

Browse trials for

• Lung Diseases 3,303
• Lung Diseases, Obstructive 2,592
• Pulmonary Disease, Chronic Obstructive 4,131

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 343 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Study arms

• Placebo comparator
  Placebo

  Participants received placebo matched to SAR440340 administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W). Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, End of Treatment (EOT) visit occurred 2 weeks after last administration of IMP i.e., at Week 52).

  Drug: Placebo · Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care · Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care · Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care · Drug: Any short-acting β agonist as prescribed by treating physician as standard of care

• Experimental
  SAR440340

  Participants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52).

  Drug: SAR440340 · Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care · Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care · Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care · Drug: Any short-acting β agonist as prescribed by treating physician as standard of care

Interventions

• DrugSAR440340

  Pharmaceutical form: Solution for injection; Route of administration: SC

  Also known as: Itepekimab, REGN3500

• DrugPlacebo

  Pharmaceutical form: Solution for injection; Route of administration: SC

• DrugAny Inhaled Corticosteroids as prescribed by treating physician as standard of care

  Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled

• DrugAny Long Acting Beta Agonist as prescribed by treating physician as standard of care

  Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

• DrugAny Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care

  Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

• DrugAny short-acting β agonist as prescribed by treating physician as standard of care

  Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled

Primary outcomes

1. Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants

   Moderate exacerbations events 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 events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.

   Time frame: From Baseline up to Week 52

Secondary outcomes

1. Average Change in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 16 Through Week 24

   FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. A mixed-effect model with repeated measures (MMRM) was first used to model the change from baseline at each post randomization timepoint up to Week 24, then the predicted values of Week 16 to Week 24 were averaged to provide an overall assessment of change from baseline in FEV1.

   Time frame: From Baseline to Week 16 through Week 24

2. Change From Baseline in Post-bronchodilator Forced Expiratory Volume (FEV1) in 1 Second at Week 24

   FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol \[100 micrograms {mcg}\] or ipratropium bromide \[20 mcg\]).

   Time frame: Baseline, Week 24

3. Time to First Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

   The time to first moderate or severe exacerbation was defined as onset date of first moderate or severe AECOPD minus randomization date + 1. The median time to first severe exacerbation was derived from Kaplan-Meier estimates. Moderate exacerbations events 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 events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death.

   Time frame: From Baseline up to 52 weeks

Baseline characteristics

3 further baseline measures are reported on the registry.

Publications

• Rabe KF, Celli BR, Wechsler ME, Abdulai RM, Luo X, Boomsma MM, Staudinger H, Horowitz JE, Baras A, Ferreira MA, Ruddy MK, Nivens MC, Amin N, Weinreich DM, Yancopoulos GD, Goulaouic H. Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. Lancet Respir Med. 2021 Nov;9(11):1288-1298. doi: 10.1016/S2213-2600(21)00167-3. Epub 2021 Jul 21. PubMed 34302758 ↗

Study documents

• Study protocol · Jun 11, 2018
• Statistical analysis plan · Aug 20, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org