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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: June 16, 2014
Last verified: June 2014

July 24, 2012
June 16, 2014
January 2013
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01651143 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Double-blind, Randomized, Placebo-controlled, 8-week 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).

Each patient's participation in the study will be approximately 13 weeks: up to 2 weeks of screening, 8 weeks of treatment 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

    Pharmaceutical form:tablets

    Route of administration: oral

  • Experimental: SAR100842
    Oral administration, twice daily, every day, for 8 weeks
    Intervention: Drug: SAR100842
  • Placebo Comparator: Placebo
    Oral administration, of matching pills, twice daily, every day, for 8 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2014
April 2014   (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
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Switzerland,   United Kingdom
 
NCT01651143
ACT12339, 2012-001369-34, U1111-1127-2854
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
June 2014

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