NCT04701983|CompletedPhase 3DMCFDA Drug

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

AERIFY-1

Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Sanofi ClinicalTrials.gov

Compare

4 other identifiers

EFC16750U1111-1250-27872024-512013-412020-001818-38

Study Type

interventional

Target

1,127

Locations

21 countries

Sites

248

Timeline

RegisteredJan 2021

StartedDec 2020

CompletionAug 2025

Brief Summary

Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives:

Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,127

participants targeted

Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Dec 2020

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach

21 countries

248 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

Study Start

First participant enrolled

December 16, 2020

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

December 30, 2020

Last Update Submit

April 9, 2026

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)

Secondary Outcomes (15)

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Baseline to Week 24
Change from baseline in post-BD FEV1
Baseline to Week 24 and Week 52
Change from baseline in pre-BD FEV1
Baseline to Week 52
Time to first moderate or severe AECOPD
Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of severe AECOPD
Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
+10 more secondary outcomes

Study Arms (3)

Itepekimab Q2W

EXPERIMENTAL

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Drug: Itepekimab SAR440340

Itepekimab Q4W

EXPERIMENTAL

SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP

Drug: Itepekimab SAR440340Drug: Placebo

Placebo

PLACEBO COMPARATOR

SC administration of matching placebo Q2W for up to 52 weeks

Drug: Placebo

Interventions

Itepekimab SAR440340DRUG

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Also known as: REGN3500

Itepekimab Q2WItepekimab Q4W

PlaceboDRUG

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Itepekimab Q4WPlacebo

Eligibility Criteria

Age40 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participant must be 40 to 85 years of age inclusive.
Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition).
Smoking history of ≥10 pack-years, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
Participants with moderate-to-severe COPD
Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough \[eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis\] has been excluded).
Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:
Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for \>24 hours in emergency department/urgent care facility.
Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
Body mass index (BMI) ≥18.0 kg/m\^2, or BMI ≥16.0 kg/m\^2 for participants enrolled in East-Asian countries.
Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:
not a women of child-bearing potential (WOCBP) OR
a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.

You may not qualify if:

Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred.
Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol \[THC\]) within 6 months prior to Screening (Visit 1A).
Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study.
Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
Hypercapnia requiring bilevel positive airway pressure (BiPAP).
Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
Uncontrolled hypertension (ie, systolic blood pressure \[BP\] \>180 mm Hg or diastolic BP \>110 mm Hg with or without use of anti-hypertensive therapy).
Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to sScreening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead
Regeneron Pharmaceuticalscollaborator

Study Sites (248)

University of Alabama at Birmingham Site Number : 8400012

Birmingham, Alabama, 34294, United States

Location

Jasper Summit Research Site Number : 8400178

Jasper, Alabama, 35501, United States

Location

Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034

Chandler, Arizona, 85286, United States

Location

Pulmonary Associates Site Number : 8400392

Phoenix, Arizona, 85027, United States

Location

Noble Clinical Research Site Number : 8400182

Tucson, Arizona, 85704-7876, United States

Location

Tucson Clinical Research Institute Site Number : 8400431

Tucson, Arizona, 85712, United States

Location

California Research Institute Site Number : 8400400

Huntington Park, California, 90255, United States

Location

Modena Allergy + Asthma Site Number : 8400036

La Jolla, California, 92037, United States

Location

Imax Clinical Trials LLC 1 Site Number : 8400419

La Palma, California, 90623, United States

Location

Downtown LA Research Center Inc. Site Number : 8400027

Los Angeles, California, 90017, United States

Location

MACRO Trials Site Number : 8400030

Los Angeles, California, 90048, United States

Location

Antelope Valley Clinical Trials Site Number : 8400003

Northridge, California, 91325, United States

Location

~Alpine Clinical Research Center Site Number : 8400180

Boulder, Colorado, 80301, United States

Location

Innovative Clinical Research Site Number : 8400017

Lafayette, Colorado, 80026, United States

Location

Clin Research W Florida Site Number : 8400004

Clearwater, Florida, 33765, United States

Location

Beautiful Minds Clinical Research Center Site Number : 8400037

Cutler Bay, Florida, 33157, United States

Location

Indago Research and Health Center Site Number : 8400187

Hialeah, Florida, 33012, United States

Location

Advanced Clinical Research Site Number : 8400409

Kendall, Florida, 33156, United States

Location

Advanced Pulmonary Research Institute Site Number : 8400455

Loxahatchee Groves, Florida, 33470, United States

Location

University of Miami/Miami VA Medical Center Site Number : 8400026

Miami, Florida, 33125, United States

Location

DL Research Solutions Inc Site Number : 8400033

Miami, Florida, 33155, United States

Location

My Community Research Center Site Number : 8400347

Miami, Florida, 33155, United States

Location

Reliant Medical Research Site Number : 8400397

Miami, Florida, 33165, United States

Location

Research Institute of South Florida,Inc Site Number : 8400006

Miami, Florida, 33173, United States

Location

PROLIVE MEDICAL RESEARCH Site Number : 8400420

Miami, Florida, 33175, United States

Location

Reed Medical Research Site Number : 8400032

Miami, Florida, 33176, United States

Location

High Quality Research Site Number : 8400406

Miami, Florida, 33184, United States

Location

Deluxe Health Center Site Number : 8400188

Miami Lakes, Florida, 33014, United States

Location

Florida Institute for Clinical Research Site Number : 8400013

Orlando, Florida, 32825-4454, United States

Location

Tellabio International Research Services Site Number : 8400411

Pembroke Pines, Florida, 33025, United States

Location

Avanza Medical Research Center Site Number : 8400376

Pensacola, Florida, 32503, United States

Location

Broward Pulmonary and Sleep Specialists Site Number : 8400031

Plantation, Florida, 33324, United States

Location

Coastal Medical Research Institute Site Number : 8400044

St. Petersburg, Florida, 33707, United States

Location

Pasadena Center for Medical Research Site Number : 8400043

St. Petersburg, Florida, 33710, United States

Location

AdtreMed Site Number : 8400442

Tampa, Florida, 33607, United States

Location

Premier Medical Associates Site Number : 8400388

The Villages, Florida, 32159, United States

Location

Appalachian Clinical Research Site Number : 8400024

Adairsville, Georgia, 30103, United States

Location

Covenant Pulmonary Critical Care Site Number : 8400183

Atlanta, Georgia, 30344, United States

Location

David Kavtaradze MD, Inc. Site Number : 8400029

Cordele, Georgia, 31015, United States

Location

Alpha Clinical Research Georgia Site Number : 8400190

Dunwoody, Georgia, 30350, United States

Location

Gwinnett Biomedical Research Site Number : 8400007

Lawrenceville, Georgia, 30046, United States

Location

GenHarp Clinical Solutions Site Number : 8400028

Evergreen Park, Illinois, 60805, United States

Location

ASHA Clinical Research Site Number : 8400408

Hammond, Indiana, 46324, United States

Location

Benchmark Research Site Number : 8400193

Covington, Louisiana, 70433, United States

Location

Paul Shapero, PC Site Number : 8400016

Bangor, Maine, 04401, United States

Location

Care Access Site Number : 8400276