Trial · NCT02921971

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

NCT02921971, Phase 2, Completed, Sanofi; results first posted 2022-02-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis. Trials, record NCT02921971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02921971

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
NCT number: NCT02921971
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: Sanofi
Conditions: Systemic Sclerosis
Interventions: SAR156597, Placebo
First posted: 2016-10-03
Last updated: 2022-03-21
Other registries' IDs: eudract:2016-001028-80
Results first posted: 2022-02-02

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Modified Rodnan Skin Score to Week 24	Baseline, Week 24	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.
Secondary	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24	Baseline, Week 24	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.
Secondary	Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24	Baseline, Week 24	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.
Secondary	Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24	Baseline, Week 24	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Modified Rodnan Skin Score to Week 24	Baseline, Week 24	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24	Baseline, Week 24	Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24	Baseline, Week 24	Analysis was performed on the ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	liters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24	Baseline, Week 24	Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	millimoles per minute per kilopascal	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Modified Rodnan Skin Score to Week 24	Placebo	-2.45	Standard Error 0.85	score on a scale
Change From Baseline in Modified Rodnan Skin Score to Week 24	SAR156597	-4.76	Standard Error 0.86	score on a scale
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24	Placebo	-0.12	Standard Error 0.08	score on a scale
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24	SAR156597	-0.09	Standard Error 0.08	score on a scale
Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24	Placebo	-0.08	Standard Error 0.04	liters
Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24	SAR156597	-0.01	Standard Error 0.04	liters
Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24	Placebo	-0.27	Standard Error 0.10	millimoles per minute per kilopascal
Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24	SAR156597	-0.12	Standard Error 0.10	millimoles per minute per kilopascal

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	49
Overall Study	STARTED	SAR156597	48
Overall Study	COMPLETED	Placebo	43
Overall Study	COMPLETED	SAR156597	44
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	SAR156597	4

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	49	5
other	Diarrhoea	Gastrointestinal disorders	SAR156597	7	48	8
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Placebo	0	49	0
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	SAR156597	3	48	3
other	Cystitis	Infections and infestations	Placebo	2	49	2
other	Cystitis	Infections and infestations	SAR156597	3	48	3
other	Nasopharyngitis	Infections and infestations	Placebo	6	49	6
other	Nasopharyngitis	Infections and infestations	SAR156597	6	48	6
other	Oral Herpes	Infections and infestations	Placebo	1	49	1
other	Oral Herpes	Infections and infestations	SAR156597	5	48	7

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	49
Total, all-cause mortality	SAR156597	1	48
Total, other adverse events	Placebo	27	49
Total, other adverse events	SAR156597	31	48
Total, serious adverse events	Placebo	5	49
Total, serious adverse events	SAR156597	4	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32963047	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SAR156597 vs Placebo: deaths from any cause	Trial comparisons
SAR156597 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02921971

GET https://conductscience.org/api/trials/v1/NCT02921971/events?page=2

API reference For AI assistants