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Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02921971
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE November 23, 2016
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
Change from baseline in mRSS [ Time Frame: From baseline to Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), assessed with SHAQ [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in respiratory function as measured by observed Forced Vital Capacity (FVC) [ Time Frame: From baseline to Week 24 ]
  • Change from baseline in observed Carbon Monoxide Diffusing Lung Capacity (DLco [corrected for hemoglobin]) [ Time Frame: From baseline to Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Sclerosis
Intervention  ICMJE
  • Drug: SAR156597 (ACT14604)
    Pharmaceutical form:Solution Route of administration: Subcutaneous
  • Drug: Placebo
    Pharmaceutical form:Solution Route of administration: Subcutaneous
Study Arms  ICMJE
  • Experimental: SAR156597
    SAR156597 will be given on a specific time period
    Intervention: Drug: SAR156597 (ACT14604)
  • Placebo Comparator: Placebo
    Placebo will be given on a specific time period
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
94
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • 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.

Exclusion criteria:

  • 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/mm^3 (except <1000/mm3 for those of African descent);
  • Platelets <100 000/mm^3;
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Estonia,   France,   Germany,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   Ukraine,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT02921971
Other Study ID Numbers  ICMJE ACT14604
2016-001028-80 ( EudraCT Number )
U1111-1179-4690 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP