Skip to main content

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 Sclerosis Scleroderma, Systemic Scleroderma, Diffuse

Eligibility

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.

Locations

  • 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, 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 0320002 accepting new patients
    Caba, C1181ACH, 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 8040004 accepting new patients
    Kyiv, 04050, Ukraine
  • Investigational Site Number 8040003 accepting new patients
    Kyiv, 04070, Ukraine
  • Investigational Site Number 6420003 accepting new patients
    Bucharest, 011171, Romania
  • Investigational Site Number 6420004 accepting new patients
    Bucharest, 011171, Romania
  • Investigational Site Number 6420005 accepting new patients
    Bucuresti, 020475, 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
December 6, 2017
I’m interested in this study!