Trial Outcomes & Findings for Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis (NCT NCT02921971)

NCT ID: NCT02921971

Last Updated: 2022-03-21

Results Overview

mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2022-03-21

Participant Flow

The study was conducted in 13 countries. A total of 97 participants were involved in the study from 21 December 2016 to 01 April 2019.

Participants were randomized in 1:1 ratio (placebo and SAR156597). Randomization was stratified based upon the participant's medical history of systemic sclerosis (SSc) associated interstitial lung disease (SSc-ILD) (yes or no). Assignment was done by Interactive Voice Response System (IVRS).

Participant milestones

Participant milestones
Measure	Placebo Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.	SAR156597 SAR156597 200 milligram (mg), single SC injection QW up to Week 24.
Overall Study STARTED	49	48
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.	SAR156597 SAR156597 200 milligram (mg), single SC injection QW up to Week 24.
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	3	1
Overall Study Other than specified above	2	1

Baseline Characteristics

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=49 Participants Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=48 Participants SAR156597 200 mg, single SC injection QW up to Week 24.	Total n=97 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 12.1 • n=93 Participants	52.3 years STANDARD_DEVIATION 10.8 • n=4 Participants	49.7 years STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male Female	38 Participants n=93 Participants	39 Participants n=4 Participants	77 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	45 Participants n=93 Participants	45 Participants n=4 Participants	90 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Modified Rodnan Skin Score (mRSS)	20.6 units on a scale STANDARD_DEVIATION 7.0 • n=93 Participants	20.5 units on a scale STANDARD_DEVIATION 6.1 • n=4 Participants	20.6 units on a scale STANDARD_DEVIATION 6.5 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on the intent to treat (ITT) population which included all randomized participants and were analyzed according to the treatment group allocated by randomization. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=47 Participants SAR156597 200 mg, single SC injection QW up to Week 24.
Change From Baseline in Modified Rodnan Skin Score to Week 24	-2.45 score on a scale Standard Error 0.85	-4.76 score on a scale Standard Error 0.86

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during past week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each activity category consisted of 2-3 items. For each items, level of difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0 (no difficulty) to 3 (maximum difficulty), where higher score indicated greater disability.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=47 Participants SAR156597 200 mg, single SC injection QW up to Week 24.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24	-0.12 score on a scale Standard Error 0.08	-0.09 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

FVC was the total amount of air (in liters) exhaled from the lungs during the lung function test measured by spirometer which assessed the change in lung function related to the disease status of an underlying ILD. Change from Baseline was calculated by subtracting Baseline value from Week 24 value.

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=47 Participants SAR156597 200 mg, single SC injection QW up to Week 24.
Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24	-0.08 liters Standard Error 0.04	-0.01 liters Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

DLco is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine amount of the tracer gas absorbed during the breath.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=47 Participants SAR156597 200 mg, single SC injection QW up to Week 24.
Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24	-0.27 millimoles per minute per kilopascal Standard Error 0.10	-0.12 millimoles per minute per kilopascal Standard Error 0.10

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 27 other events

Deaths: 1 deaths

SAR156597

Serious events: 4 serious events

Other events: 31 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=49 participants at risk Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=48 participants at risk SAR156597 200 mg single SC injection QW up to Week 24.
Cardiac disorders Cardiac Failure	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Cardiac disorders Cardiomyopathy	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Gastrointestinal disorders Intestinal Pseudo-Obstruction	2.0% 1/49 • Number of events 3 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
General disorders Chest Pain	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Bronchiolitis	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Pneumonia	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Pneumonia Bacterial	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Pyelonephritis Acute	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Investigations Echocardiogram Abnormal	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Renal and urinary disorders Scleroderma Renal Crisis	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	2.1% 1/48 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	0.00% 0/48 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.

Other adverse events

Other adverse events
Measure	Placebo n=49 participants at risk Placebo (for SAR156597), single SC injection QW up to Week 24.	SAR156597 n=48 participants at risk SAR156597 200 mg single SC injection QW up to Week 24.
Gastrointestinal disorders Diarrhoea	8.2% 4/49 • Number of events 5 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	14.6% 7/48 • Number of events 8 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	6.2% 3/48 • Number of events 3 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Cystitis	4.1% 2/49 • Number of events 2 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	6.2% 3/48 • Number of events 3 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Nasopharyngitis	12.2% 6/49 • Number of events 6 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	12.5% 6/48 • Number of events 6 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Oral Herpes	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	10.4% 5/48 • Number of events 7 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Pharyngitis	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	6.2% 3/48 • Number of events 3 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Infections and infestations Upper Respiratory Tract Infection	4.1% 2/49 • Number of events 2 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	10.4% 5/48 • Number of events 6 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	8.3% 4/48 • Number of events 4 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Nervous system disorders Headache	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	8.3% 4/48 • Number of events 7 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/49 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	10.4% 5/48 • Number of events 5 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/49 • Number of events 1 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	6.2% 3/48 • Number of events 4 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Skin Ulcer	30.6% 15/49 • Number of events 23 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually received.	16.7% 8/48 • Number of events 20 • All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks). Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the study drug and were analyzed according to the treatment actually 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