Trial record 1 of 1 for:
ACT15104
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 : October 12, 2020
|
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Drug: Itepekimab (SAR440340) 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 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 343 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | July 16, 2018 |
| Actual Primary Completion Date : | October 3, 2019 |
| Actual Study Completion Date : | February 19, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: SAR440340
Administration of SAR440340 monotherapy injection
|
Drug: Itepekimab (SAR440340)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous 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 |
|
Placebo Comparator: Placebo
Administration of matching placebo for injection of SAR440340
|
Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous 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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546907
Locations
Show 83 study locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT03546907 |
| Other Study ID Numbers: |
ACT15104 2017-003290-34 ( EudraCT Number ) U1111-1194-2134 ( Other Identifier: UTN ) |
| First Posted: | June 6, 2018 Key Record Dates |
| Last Update Posted: | October 12, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Cholinergic Agents |
Muscarinic Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinergic Agonists |