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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Systemic Sclerosis

Eligibility

You can join if…

Open to people ages 18 years and up

:

  • 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.

You CAN'T join if...

  • Aged <18 years.
  • Disease duration for>36 months from time of first non-Raynaud's phenomenon manifestation.
  • Modified Rodnan Skin Score (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 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 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 randomization (or baseline visit); or expected changes during the course of the study.
  • Treatment with etanercept, cyclosporine A, intravenous immunoglobulin (IVIG),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 (ALT) or aspartate transaminase (AST)>2 times upper limit of normal range (ULN);
  • Hemoglobin <11 g/100 mL for male and <10 g/100 mL for female;
  • Neutrophils <1500/mm^3 (except <1000/mm3 for those of African descent);
  • Platelets <100 000/mm^3;
  • Creatinine ≥150 µmol/L. Note: Laboratory parameters may be repeated once during the screening period if felt to be spurious or due to technical error in order to determine eligibility.
  • Current history of substance and/or alcohol abuse
  • Current employee of Sanofi or has an immediate family member (eg, spouse, parents,child or sibling) who is a current employee of Sanofi.
  • Currently incarcerated or anticipated/scheduled to be incarcerated during the course of the study.
  • 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 G for United Kingdom), and/or who are unwilling or unable to be tested for pregnancy.

Note: Women of childbearing potential must have a confirmed negative pregnancy test at screening and randomization visits. They must use an effective contraceptive method throughout the entire duration of the study treatment, and for at least 12 weeks after the last administration of IMP. Postmenopausal women must be amenorrheic for at least 12 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations

  • 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 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 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 6420003 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT02921971
Phase
Phase 2
Study Type
Interventional
Last Updated
August 1, 2017
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