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 SAR156597 (ACT14604) SAR156597

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 8400007 accepting new patients
    Houston Texas 77030 United States
  • Investigational Site Number 4840005 accepting new patients
    Guadalajara 44160 Mexico
  • Investigational Site Number 4840002 accepting new patients
    Guadalajara 44690 Mexico

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT02921971
Phase
Phase 2
Study Type
Interventional
Last Updated
June 14, 2018