Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
a study on Systemic Sclerosis
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc. Secondary Objectives: - 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 for 24 weeks.
Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study
The total study duration per patient will be 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and a 11-week follow-up with no study drug treatment.
Systemic Sclerosis Sclerosis Scleroderma, Systemic Scleroderma, Diffuse
You can join if…
Open to people ages 18 years and up
- Systemic Sclerosis (SSc) 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.
You CAN'T join if...
- Age <18 years of age.
- Disease duration for >36 months from time of first non-Raynaud's phenomenon manifestation.
- MRSS <10 or >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 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 HBcAb with positive HBsAb and presence of hepatitis B DNA(HBV DNA).
- Abnormal Hepatitis C tests: Positive anti-hepatitis C virus antibody (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-interstitial lung disease) or previous, active or pending surgical disorder, or any condition that may affect patient safety in the judgment of the Investigator.
- At screening, the % predicted forced vital capacity (FVC) is ≤75% AND % predicted carbon monoxide diffusing lung capacity (DLCO) after hemoglobin correction is ≤40%
- History of heart failure (including acutely decompensated in the setting of preserved ejection fraction), left ventricular ejection fraction ≤ 45%, coronary artery disease,angina, myocardial infarction, ischemic cardiomyopathy and/or hypertrophic cardiomyopathy
- Any prior history of malignancy or active malignancy, including lymphoproliferative diseases (except successfully-treated carcinoma in-situ of the cervix, non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin) within 5 years prior to baseline.
- Ischemic ECG changes (except those NOT supported by the findings of a left heart catheterization performed in the last year) and/or other clinically significant ECG findings. (All abnormal ECG finding will be reviewed and confirmed by a local cardiologist.)
- High dose steroids (>10 mg/day prednisolone equivalent); or change in steroid dose within 4 weeks prior to/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 ultra-high 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, rapamycin,D-penicillamine, 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 screening.
- Treatment with any investigational drug within 1 month of screening, or 5 half-lives,if known (whichever is longer).
- Abnormal laboratory tests at screening:
- Alanine transaminase or aspartate transaminase >2 times upper limit of normal range;
- Hemoglobin <11 g/100 mL for male and <10 g/100 mL for female;
Neutrophils <1500/mm3 (except <1000/mm3 for those of African descent);
Platelets <100 000/mm3;
- Creatinine ≥150 µmol/L.
- Current history of substance and/or alcohol abuse
- Any condition or circumstance that will preclude the patient from following and completing protocol requirements, in the opinion of the Investigator.
- Pregnant or breastfeeding woman
- Women who are of childbearing potential not protected by highly-effective contraceptive method(s) of birth control as (defined in the informed consent form and/or Appendix A for United Kingdom), and/or who are unwilling or unable to be tested for pregnancy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
- Investigational Site Number 8400006 accepting new patients
San Francisco, California, 94143, United States
- Investigational Site Number 4840001 accepting new patients
Chihuahua, 31000, Mexico
- Investigational Site Number 4840003 accepting new patients
Monterrey, 64460, Mexico
- Investigational Site Number 4840005 accepting new patients
Guadalajara, 44158, Mexico
- Investigational Site Number 4840002 accepting new patients
Guadalajara, 44690, Mexico
- Investigational Site Number 8400004 accepting new patients
Ann Arbor, Michigan, 48109-5422, United States
- Investigational Site Number 8400002 accepting new patients
Cleveland, Ohio, 44195, United States
- Investigational Site Number 8400005 accepting new patients
Washington, D.C., District of Columbia, 20037, United States
- Investigational Site Number 8400003 accepting new patients
Baltimore, Maryland, 21287, United States
- Investigational Site Number 6430002 accepting new patients
Kemerovo, 650000, Russian Federation
- Investigational Site Number 6430005 accepting new patients
Moscow, 115404, Russian Federation
- Investigational Site Number 6430001 accepting new patients
Moscow, 115522, Russian Federation
- Investigational Site Number 6430004 accepting new patients
Moscow, 125284, Russian Federation
- Investigational Site Number 6430003 accepting new patients
Ufa, 450005, Russian Federation
- Investigational Site Number 8260001 accepting new patients
London, United Kingdom
- Investigational Site Number 2330002 accepting new patients
Tallinn, 10138, Estonia
- Investigational Site Number 2330001 accepting new patients
Tallinn, 13419, Estonia
- Investigational Site Number 0560001 accepting new patients
Gent, 9000, Belgium
- Investigational Site Number 0560002 accepting new patients
Leuven, 3000, Belgium
- Investigational Site Number 2500001 accepting new patients
Lille, 59037, France
- Investigational Site Number 2500003 accepting new patients
Montpellier, 34295, France
- Investigational Site Number 2500004 accepting new patients
Paris Cedex 14, 75679, France
- Investigational Site Number 2500002 accepting new patients
Strasbourg Cedex, 67098, France
- Investigational Site Number 2760003 accepting new patients
Bad Nauheim, 61231, Germany
- Investigational Site Number 2760001 accepting new patients
Berlin, 10117, Germany
- Investigational Site Number 2760002 accepting new patients
Köln, 50937, Germany
- Investigational Site Number 2760004 accepting new patients
Ulm, 89081, Germany
- Investigational Site Number 6160001 accepting new patients
Poznan, 61-397, Poland
- Investigational Site Number 6160002 accepting new patients
Warszawa, 02-691, Poland
- Investigational Site Number 6160003 accepting new patients
Wroclaw, 52-416, Poland
- Investigational Site Number 0400001 accepting new patients
Wien, 1090, Austria
- Investigational Site Number 0320003 accepting new patients
Buenos Aires, C1015ABO, Argentina
- Investigational Site Number 0320001 accepting new patients
San Miguel De Tucuman, T4000AXL, Argentina
- Investigational Site Number 3800002 accepting new patients
Firenze, 50139, Italy
- Investigational Site Number 3800004 accepting new patients
Genova, 16132, Italy
- Investigational Site Number 3800001 accepting new patients
Milano, 20122, Italy
- Investigational Site Number 3800005 accepting new patients
Milano, 20122, Italy
- Investigational Site Number 8040001 accepting new patients
Kyiv, 02125, Ukraine
- Investigational Site Number 8040002 accepting new patients
Kyiv, 03151, Ukraine
- Investigational Site Number 6420003 accepting new patients
Bucharest, 011171, Romania
- Investigational Site Number 6420004 accepting new patients
Bucharest, 011171, Romania
- Investigational Site Number 6420001 accepting new patients
Cluj Napoca, 400006, Romania
- Investigational Site Number 6420002 accepting new patients
Targu Mures, 540142, Romania
- accepting new patients
- Start Date
- Completion Date
- Phase 2
- Lead Scientist
- Study Type
- Last Updated
- October 10, 2017
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02921971.