Trial Outcomes & Findings for Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants (NCT NCT03387852)

Last Updated: 2022-06-14

Results Overview

An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

296 participants

Primary outcome timeframe

From Baseline up to Week 12

Results posted on

2022-06-14

Participant Flow

The study was conducted from 12-March-2018 to 7-August-2019. Participants were screened at 70 centers across 8 countries, out of which 68 centers randomized at least 1 participant.

A total of 499 participants were screened, out of which 296 participants were enrolled and randomized to 1 of the 4 treatment groups.

Participant milestones

Participant milestones
Measure	Placebo Participants received 2 subcutaneous (SC) injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo once every 2 weeks (Q2W) for 12 weeks.	SAR440340 300 mg Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.	SAR440340 + Dupilumab Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Overall Study STARTED	74	73	74	75
Overall Study Treated	74	73	74	74
Overall Study COMPLETED	41	55	47	56
Overall Study NOT COMPLETED	33	18	27	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 2 subcutaneous (SC) injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo once every 2 weeks (Q2W) for 12 weeks.	SAR440340 300 mg Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.	SAR440340 + Dupilumab Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Overall Study Adverse event (AE)	3	0	2	0
Overall Study Loss of asthma control (LOAC)	28	16	20	14
Overall Study Withdrawal by participant	1	1	3	2
Overall Study Other- Unspecified	1	1	2	1
Overall Study Poor compliance to protocol	0	0	0	1
Overall Study Randomized and not treated	0	0	0	1

Baseline Characteristics

Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=74 Participants Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.	SAR440340 300 mg n=73 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=74 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg n=75 Participants Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.	Total n=296 Participants Total of all reporting groups
Age, Continuous	47.0 years STANDARD_DEVIATION 11.4 • n=5 Participants	49.0 years STANDARD_DEVIATION 13.9 • n=7 Participants	49.1 years STANDARD_DEVIATION 12.0 • n=5 Participants	51.3 years STANDARD_DEVIATION 12.7 • n=4 Participants	49.1 years STANDARD_DEVIATION 12.6 • n=21 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	50 Participants n=7 Participants	51 Participants n=5 Participants	41 Participants n=4 Participants	189 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	34 Participants n=4 Participants	107 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	68 Participants n=7 Participants	69 Participants n=5 Participants	73 Participants n=4 Participants	281 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline up to Week 12

Population: The analysis was performed on modified intent-to-treat (mITT) population that included all randomized participants who have received at least 1 dose of investigational medicinal product (IMP) analyzed according to the treatment group allocated by randomization.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received 2 SC injections of placebo matching to SAR440340 along with 1 SC injection of placebo matching to dupilumab once Q2W for 12 weeks.	SAR440340 300 mg n=73 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of placebo matching to dupilumab, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=74 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg n=74 Participants Participants received 1 injection of dupilumab 300 mg along with 2 injections of placebo matched to SAR440340, SC Q2W for 12 weeks.
Percentage of Participants With Loss of Asthma Control	40.5 percentage of participants	21.9 percentage of participants	27.0 percentage of participants	18.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on mITT population. Here, "Overall number of participants analyzed" signifies participants with available data for this outcome measure.

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Pre-bronchodilator FEV1 refers to the spirometry performed after a wash period of bronchodilators (i.e., not earlier than 6 hours) after the last dose of albuterol/salbutamol or levalbuterol/levosalbutamol from a primed meter dose inhaler and withholding the last dose of long-acting β2 adrenergic agonist (LABA) for at least 12 hours, and prior to administration of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received 2 SC injections of placebo matching to SAR440340 along with 1 SC injection of placebo matching to dupilumab once Q2W for 12 weeks.	SAR440340 300 mg n=58 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of placebo matching to dupilumab, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=49 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg n=56 Participants Participants received 1 injection of dupilumab 300 mg along with 2 injections of placebo matched to SAR440340, SC Q2W for 12 weeks.
Change From Baseline at Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	0.06 liters Standard Deviation 0.35	0.11 liters Standard Deviation 0.34	0.06 liters Standard Deviation 0.37	0.14 liters Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on mITT population. Here, "Overall number of participants analyzed" signifies participants with available data for this outcome measure.

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 refers to the spirometry performed within 30 minutes after administration of bronchodilator.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Participants received 2 SC injections of placebo matching to SAR440340 along with 1 SC injection of placebo matching to dupilumab once Q2W for 12 weeks.	SAR440340 300 mg n=58 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of placebo matching to dupilumab, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=51 Participants Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300 mg n=57 Participants Participants received 1 injection of dupilumab 300 mg along with 2 injections of placebo matched to SAR440340, SC Q2W for 12 weeks.
Change From Baseline at Week 12 in Post-bronchodilator Forced Expiratory Volume in 1 Second	-0.02 liters Standard Deviation 0.27	-0.00 liters Standard Deviation 0.33	0.06 liters Standard Deviation 0.41	0.09 liters Standard Deviation 0.42

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

SAR440340 300mg

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

SAR440340 + Dupilumab

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Dupilumab 300mg

Serious events: 3 serious events

Other events: 28 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=74 participants at risk Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.	SAR440340 300mg n=73 participants at risk Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=74 participants at risk Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300mg n=74 participants at risk Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Cardiac disorders Aortic Valve Incompetence	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Hepatobiliary disorders Cholecystitis Acute	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Abscess Jaw	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Pneumonia	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Pyelonephritis Acute	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Injury, poisoning and procedural complications Alcohol Poisoning	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Investigations Alanine Aminotransferase Increased	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Nervous system disorders Vascular Encephalopathy	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Vascular disorders Aortic Aneurysm	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/73 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Vascular disorders Deep Vein Thrombosis	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.

Other adverse events

Other adverse events
Measure	Placebo n=74 participants at risk Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.	SAR440340 300mg n=73 participants at risk Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab placebo, SC Q2W for 12 weeks.	SAR440340 + Dupilumab n=74 participants at risk Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.	Dupilumab 300mg n=74 participants at risk Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Gastrointestinal disorders Nausea	2.7% 2/74 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	5.5% 4/73 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	2.7% 2/74 • Number of events 2 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
General disorders Injection Site Reaction	5.4% 4/74 • Number of events 6 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	6.8% 5/74 • Number of events 16 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	5.4% 4/74 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Nasopharyngitis	12.2% 9/74 • Number of events 10 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	17.8% 13/73 • Number of events 15 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	10.8% 8/74 • Number of events 8 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	12.2% 9/74 • Number of events 11 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Upper Respiratory Tract Infection Bacterial	2.7% 2/74 • Number of events 2 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	5.4% 4/74 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	2.7% 2/74 • Number of events 2 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Urinary Tract Infection	2.7% 2/74 • Number of events 3 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	6.8% 5/74 • Number of events 7 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	4.1% 3/74 • Number of events 3 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Infections and infestations Viral Upper Respiratory Tract Infection	6.8% 5/74 • Number of events 6 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	4.1% 3/73 • Number of events 3 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	6.8% 5/74 • Number of events 7 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	2.7% 2/74 • Number of events 3 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Musculoskeletal and connective tissue disorders Back Pain	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	5.5% 4/73 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	2.7% 2/74 • Number of events 2 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	4.1% 3/74 • Number of events 3 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Nervous system disorders Headache	9.5% 7/74 • Number of events 7 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	8.2% 6/73 • Number of events 7 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	6.8% 5/74 • Number of events 9 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	13.5% 10/74 • Number of events 12 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 5/74 • Number of events 5 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/73 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	1.4% 1/74 • Number of events 1 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	4.1% 3/73 • Number of events 4 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	0.00% 0/74 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.	6.8% 5/74 • Number of events 6 • From first administration of IMP up to the final visit (Week 32) regardless of seriousness or relationship to IMP Analysis was performed on safety population that included all enrolled participants who had received at least 1 dose of study drug, analyzed as per actual treatment received.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Publication restrictions are in place

Restriction type: OTHER