Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
- Registration Number
- NCT02921971
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR156597 SAR156597 SAR156597 200 milligram (mg), single SC injection QW up to Week 24. Placebo Placebo Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (44)
Investigational Site Number 8400005
🇺🇸Washington, District of Columbia, United States
Investigational Site Number 8400007
🇺🇸Houston, Texas, United States
Investigational Site Number 0320005
🇦🇷Capital Federal, Argentina
Investigational Site Number 2330001
🇪🇪Tallinn, Estonia
Investigational Site Number 2500003
🇫🇷Montpellier, France
Investigational Site Number 0560002
🇧🇪Leuven, Belgium
Investigational Site Number 2500002
🇫🇷Strasbourg Cedex, France
Investigational Site Number 2760003
🇩🇪Bad Nauheim, Germany
Investigational Site Number 3800005
🇮🇹Milano, Italy
Investigational Site Number 3800004
🇮🇹Genova, Italy
Investigational Site Number 4840001
🇲🇽Chihuahua, Mexico
Investigational Site Number 4840005
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840002
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840003
🇲🇽Monterrey, Mexico
Investigational Site Number 6160001
🇵🇱Poznan, Poland
Investigational Site Number 6160002
🇵🇱Warszawa, Poland
Investigational Site Number 6160003
🇵🇱Wroclaw, Poland
Investigational Site Number 6420003
🇷🇴Bucharest, Romania
Investigational Site Number 6420005
🇷🇴Bucuresti, Romania
Investigational Site Number 6420004
🇷🇴Bucharest, Romania
Investigational Site Number 6420002
🇷🇴Targu Mures, Romania
Investigational Site Number 6430002
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number 8400002
🇺🇸Cleveland, Ohio, United States
Investigational Site Number 8400006
🇺🇸San Francisco, California, United States
Investigational Site Number 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430003
🇷🇺Ufa, Russian Federation
Investigational Site Number 8040001
🇺🇦Kyiv, Ukraine
Investigational Site Number 8040003
🇺🇦Kyiv, Ukraine
Investigational Site Number 8040002
🇺🇦Kyiv, Ukraine
Investigational Site Number 8040004
🇺🇦Kyiv, Ukraine
Investigational Site Number 8260001
🇬🇧London, United Kingdom
Investigational Site Number 2760002
🇩🇪Köln, Germany
Investigational Site Number 3800006
🇮🇹Orbassano, Italy
Investigational Site Number 6420001
🇷🇴Cluj Napoca, Romania
Investigational Site Number 0320003
🇦🇷Buenos Aires, Argentina
Investigational Site Number 0320002
🇦🇷Caba, Argentina
Investigational Site Number 0560001
🇧🇪Gent, Belgium
Investigational Site Number 2760004
🇩🇪Ulm, Germany
Investigational Site Number 0320001
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 2500004
🇫🇷Paris Cedex 14, France
Investigational Site Number 2760001
🇩🇪Berlin, Germany
Investigational Site Number 3800001
🇮🇹Milano, Italy