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Proof of Biological Activity of SAR100842 in Systemic Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01651143
First received: July 24, 2012
Last updated: February 26, 2016
Last verified: February 2016

July 24, 2012
February 26, 2016
January 2013
November 2013   (final data collection date for primary outcome measure)
Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01651143 on ClinicalTrials.gov Archive Site
  • Change from baseline to Week 8 in biomarkers obtained from blood and skin [ Time Frame: Day 1 and Week 8 (core part) ] [ Designated as safety issue: No ]
  • Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS) [ Time Frame: Day 1 and Week 8 (core part) ] [ Designated as safety issue: No ]
  • Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score [ Time Frame: Day 1 and Week 8 (core part) ] [ Designated as safety issue: No ]
  • Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin [ Time Frame: at Day 1 and 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) [ Time Frame: at Day 1 and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

Primary Objective:

- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.

Secondary Objectives:

  • To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
  • To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
  • To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
  • To document long term safety of SAR100842 during the extension part.

Core part: randomized, double-blind, placebo-controlled study - 8-week treatment Extension part for participants completing the core part: Open label non-controlled study - 16-week treatment

Each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Sclerosis
  • Drug: SAR100842

    Pharmaceutical form: tablets

    Route of administration: oral

  • Drug: Placebo (for SAR100842)

    Pharmaceutical form: tablets

    Route of administration: oral

  • Experimental: SAR100842

    Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks

    Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks

    Intervention: Drug: SAR100842
  • Placebo Comparator: Placebo

    Core part: Placebo (for SAR100842), oral administration twice daily, for 8 weeks

    Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks

    Interventions:
    • Drug: SAR100842
    • Drug: Placebo (for SAR100842)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion criteria :

- Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and <36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) ≥ 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies.

Exclusion criteria:

  1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening
  2. Serum creatinine > 2.0 mg/dL
  3. Gastrointestinal involvement preventing oral administration of study drug
  4. Severe cardiac and/or pulmonary disease

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Switzerland,   United Kingdom
Germany
 
NCT01651143
ACT12339, 2012-001369-34, U1111-1127-2854
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2016

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