Proof of biological activity of SAR100842 in Systemic Sclerosis

Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001369-34-GB

Enrollment

Registered

2012-06-15

Start date

2012-10-26

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis MedDRA version: 15.1 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Code: SAR100842 Pharmaceutical Form: Tablet CAS Number: 1195941-38-8 Current Sponsor code: SAR100842 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening 2.Serum creatinine > 2.0 mg/dL 3. Gastrointestinal involvement preventing oral administration of study drug 4. Severe cardiac and/or pulmonary disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.; Secondary Objective: To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophoshatidic acid (LPA) receptor signaling markers in blood and skin To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the Modified Rodnan Skin score (mRSS) To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ) To document the long term safety and tolerability of SAR100842 ;Primary end point(s): Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events);Timepoint(s) of evaluation of this end point: Up to 8 weeks	—

Measure

Time frame

Main Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.; Secondary Objective: To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophoshatidic acid (LPA) receptor signaling markers in blood and skin To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the Modified Rodnan Skin score (mRSS) To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ) To document the long term safety and tolerability of SAR100842 ;Primary end point(s): Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events);Timepoint(s) of evaluation of this end point: Up to 8 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) Safety and tolerability of SAR100842 ; Timepoint(s) of evaluation of this end point: Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin - Time Frame: at Day 1 and 8 weeks Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) - Time Frame: at Day 1 and 8 weeks Safey and tolerability of SAR100842 - Time Frame: up to 24 weeks	—

Measure

Time frame

Secondary end point(s): Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) Safety and tolerability of SAR100842 ; Timepoint(s) of evaluation of this end point: Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin - Time Frame: at Day 1 and 8 weeks Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) - Time Frame: at Day 1 and 8 weeks Safey and tolerability of SAR100842 - Time Frame: up to 24 weeks

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Countries

Canada, Germany, Italy, Switzerland, United Kingdom, United States

Contacts

Public ContactMedical Information

Sanofi-aventis recherche & développement

uk-medicalinformation@sanofi.com00441483505515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026