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Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT02921971
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: SAR156597 (ACT14604) Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 23, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: SAR156597
SAR156597 will be given on a specific time period
Drug: SAR156597 (ACT14604)
Pharmaceutical form:Solution Route of administration: Subcutaneous

Placebo Comparator: Placebo
Placebo will be given on a specific time period
Drug: Placebo
Pharmaceutical form:Solution Route of administration: Subcutaneous




Primary Outcome Measures :
  1. Change from baseline in mRSS [ Time Frame: From baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), assessed with SHAQ [ Time Frame: From baseline to Week 24 ]
  2. Change from baseline in respiratory function as measured by observed Forced Vital Capacity (FVC) [ Time Frame: From baseline to Week 24 ]
  3. Change from baseline in observed Carbon Monoxide Diffusing Lung Capacity (DLco [corrected for hemoglobin]) [ Time Frame: From baseline to Week 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921971


  Show 49 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02921971     History of Changes
Other Study ID Numbers: ACT14604
2016-001028-80 ( EudraCT Number )
U1111-1179-4690 ( Other Identifier: UTN )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases