Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651143
• Other study ID #: ACT12339
• Secondary ID: 2012-001369-34U1
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2012
• Last updated: June 16, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• SAR100842
Pharmaceutical form:tablets Route of administration: oral
• Placebo
Pharmaceutical form:tablets Route of administration: oral

Locations

Country	Name	City	State
France	Investigational Site Number 250003	Lille
France	Investigational Site Number 250001	Paris Cedex 14
Italy	Investigational Site Number 380001	Milano
Switzerland	Investigational Site Number 756001	Zürich
United Kingdom	Investigational Site Number 826001	London
United Kingdom	Investigational Site Number 826002	Salford
United States	Investigational Site Number 840002	Ann Arbor	Michigan
United States	Investigational Site Number 840004	Baltimore	Maryland
United States	Investigational Site Number 840001	Boston	Massachusetts
United States	Investigational Site Number 840007	New Brunswick	New Jersey
United States	Investigational Site Number 840008	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840006	Scottsdale	Arizona
United States	Investigational Site Number 840003	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events)		Up to 8 weeks	Yes
Secondary	Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin		at Day 1 and 8 weeks	No
Secondary	Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ)		at Day 1 and 8 weeks	No