Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Phase 2

Completed

• Conditions: Systemic Sclerosis
• Interventions: Drug: SAR156597; Drug: Placebo

• 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.

Study Timeline

• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Study Start: 2016-12-21
• Primary Completion: 2019-01-14
• Study Completion: 2019-04-01
• Disposition First Submitted: 2020-01-13
• Disposition First Submitted QC: 2020-01-13
• Disposition First Posted: 2020-01-14
• Results First Submitted: 2022-01-07
• Results First Submitted QC: 2022-01-07
• Results First Posted: 2022-02-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

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 8400006; 🇺🇸 San Francisco, California, United States

Investigational Site Number 8400005; 🇺🇸 Washington, 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

Investigational Site Number 0320002; 🇦🇷 Caba, Argentina

Investigational Site Number 0320005; 🇦🇷 Capital Federal, Argentina

Investigational Site Number 0320001; 🇦🇷 San Miguel De Tucuman, Argentina

Investigational Site Number 0560001; 🇧🇪 Gent, Belgium

Investigational Site Number 0560002; 🇧🇪 Leuven, Belgium

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