Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: * To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. * To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. * To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. * To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. * To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.
The total study duration per participant was 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and an 11-week follow-up with no study drug treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Solution Route of administration: Subcutaneous
Investigational Site Number 8400006
San Francisco, California, United States
Investigational Site Number 8400005
Washington D.C., District of Columbia, United States
Investigational Site Number 8400002
Cleveland, Ohio, United States
Investigational Site Number 8400007
Houston, Texas, United States
Investigational Site Number 0320003
Buenos Aires, Argentina
Change From Baseline in Modified Rodnan Skin Score to 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.
Time frame: Baseline, Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to 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.
Time frame: Baseline, Week 24
Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to 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.
Time frame: Baseline, Week 24
Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to 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.
Time frame: Baseline, Week 24
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Investigational Site Number 0320002
Caba, Argentina
Investigational Site Number 0320005
Capital Federal, Argentina
Investigational Site Number 0320001
San Miguel de Tucumán, Argentina
Investigational Site Number 0560001
Ghent, Belgium
Investigational Site Number 0560002
Leuven, Belgium
...and 34 more locations