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Trial record 1 of 1 for:    ACT15104
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546907
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE July 16, 2018
Actual Primary Completion Date October 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Rate of moderate-to-severe acute Exacerbations in chronic obstructive pulmonary disease (AECOPD) patients [ Time Frame: Over up to 52 weeks treatment period ]
Annualized rate of moderate-to-severe AECOPD over up to 52 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 16-24 ]
    Average change in pre-bronchodilator FEV1 from Week 16 to Week 24.
  • Time to first COPD Exacerbation [ Time Frame: Up to 52 weeks ]
    Time to first moderate or severe AECOPD.
  • Adverse Events [ Time Frame: Screening up to 72 weeks ]
    Monitor treatment emergent adverse events and serious adverse events.
  • Change in post-bronchodilator FEV1 [ Time Frame: Baseline to Week 24 ]
    Change from baseline to Week 24 in FEV1 (post-bronchodilator).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 16-24 ]
    Change in pre-bronchodilator FEV1 from Week 16 to Week 24.
  • Time to first COPD Exacerbation [ Time Frame: Up to 52 weeks ]
    Time to first moderate or severe AECOPD.
  • Adverse Events [ Time Frame: Screening up to 72 weeks ]
    Monitor treatment emergent adverse events and serious adverse events.
  • Change in post-bronchodilator FEV1 [ Time Frame: Baseline to Week 24 ]
    Change from baseline to Week 24 in FEV1 (post-bronchodilator).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Brief 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.

Detailed Description Study participation for each patient will be up to a total of 46 weeks to 76 weeks including up to 10 days to 4 weeks of screening, 24 to 52 week treatment period on investigational medical product (IMP), and 20 weeks of post IMP treatment period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
    Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
  • Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
    Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
  • Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
    Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
  • Drug: Any short-acting β agonist as prescribed by treating physician as standard of care
    Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: inhaled
Study Arms  ICMJE
  • Experimental: SAR440340
    Administration of SAR440340 monotherapy injection
    Interventions:
    • 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
  • Placebo Comparator: Placebo
    Administration of matching placebo for injection of SAR440340
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
343
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
340
Actual Study Completion Date  ICMJE February 19, 2020
Actual Primary Completion Date October 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Chile,   Germany,   Poland,   Russian Federation,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546907
Other Study ID Numbers  ICMJE ACT15104
2017-003290-34 ( EudraCT Number )
U1111-1194-2134 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP