Systemic sclerosis MedDRA version: 19.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: SAR156597
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: SAR156597
Concentration unit: mg milligram(s)
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Systemic Sclerosis according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria. -Diffuse cutaneous form of SSc according to Leroy’s criteria. -Able and willing to sign the written informed consent form with comprehension of its contents and comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: -Aged 36 months from time of first non-Raynaud’s phenomenon manifestation. -Modified Rodnan Skin Score (mRSS) 35 at screening and baseline visits. -History of vasculitis, active or in remission. -Diagnosis of connective tissue diseases (other than SSc) or overlap syndrome (eg, polymyositis/scleroderma). -Positive Human Immunodeficiency Virus (HIV) serology or a known history of HIV infection, active or in remission. -Abnormal hepatitis B and/or hepatitis C tests indicative of active or chronic infection: -Abnormal Hepatitis B tests: Positive hepatitis B surface antigen (HBsAg) OR positive total hepatitis B core antibody (HBcAb) with negative hepatitis B surface antibody (HBsAb) OR positive total hepatitis B core antibody with positive HBsAb and presence of hepatitis B DNA (HBV DNA). -Abnormal Hepatitis C tests: Positive anti-HCV Ab and positive HCV RNA. -Positive or 2 confirmed indeterminate Quantiferon-TB Gold tests at screening (regardless of prior treatment status). -Serious infection (eg, pneumonia, pyelonephritis) within 4 weeks of screening, infection requiring hospitalization or intravenous antibiotics within 4 weeks of screening or chronic bacterial infection (eg, osteomyelitis). -History of anaphylaxis to any biologic therapy. -Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal or neurologic other than SSc or SSc-ILD) or previous, active or pending surgical disorder, or any condition that may affect patient safety in the judgment of the Investigator. -Any prior history of malignancy or active malignancy, including lymphoproliferative diseases (except successfully-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to baseline. -Clinically significant abnormal electrocardiogram (ECG) at screening that may affect the conduct of the study in the judgment of the Investigator. -High dose steroids (>10 mg/day prednisolone equivalent); or change in steroid dose within 4 weeks prior to screening or during the screening period; or expected changes during the course of the study. -Previous treatment with rituximab within 12 months prior to screening. -Previous treatment with bone marrow transplantation, total lymphoid irradiation or ablative ultrahigh dose cyclophosphamide. -Treatment with high dose immunosuppressive drug (eg, cyclophosphamide >1 mg/kg oral/day or >750 mg IV/month; azathioprine >100 mg/day; methotrexate >15 mg/week; mycophenolate mofetil >2 g/day) within 3 months of screening or change in dose within 4 weeks prior to baseline. -Treatment with etanercept, cyclosporine A, intravenous immunoglobulin (IVIG), rapamycin, Dpenicillamine, tyrosine kinase inhibitors within 4 weeks of screening or antithymocyte globulin within 6 months of screening. -Treatment with infliximab, certolizumab, golimumab, abatacept, or adalimumab, tocilizumab within 8 weeks of screening or anakinra within 1 week of s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously on skin fibrosis in patients with dcSSc.; Secondary Objective: -To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in patients with dcSSc. -To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in patients with dcSSc. -To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc. -To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of SAR156597 in patients with dcSSc. -To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597 administered subcutaneously. ;Primary end point(s): Change from baseline in mRSS;Timepoint(s) of evaluation of this end point: From baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From baseline to Week 24; Secondary end point(s): - Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), assessed with SHAQ - Change from baseline in respiratory function as measured by observed Forced Vital Capacity (FVC) Change from baseline in observed Carbon Monoxide Diffusing Lung Capacity (DLco [corrected for hemoglobin]) | — |
Countries
Argentina, Austria, Belgium, Estonia, France, Germany, Italy, Mexico, Poland, Romania, Russian Federation, United Kingdom, United States
Outcome results
None listed