Proof of Biological Activity of SAR100842 in Systemic Sclerosis

This study is currently recruiting participants.

Verified May 2013 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01651143

First received: July 24, 2012

Last updated: May 15, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2012

Last Updated Date

May 15, 2013

Start Date ^ICMJE

December 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01651143 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Sclerosis

Intervention ^ICMJE

Drug: SAR100842
Pharmaceutical form:tablets

Route of administration: oral
Drug: Placebo
Pharmaceutical form:tablets

Route of administration: oral

Study Arm (s)

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

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For site information, send an email with site number to

Contact-Us@sanofi.com

Location Countries ^ICMJE

United States, France, Germany, Italy, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01651143

Other Study ID Numbers ^ICMJE

ACT12339, 2012-001369-34, U1111-1127-2854

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

May 2013

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

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