Proof of Biological Activity of SAR100842 in Systemic Sclerosis

NCT01651143 | Completed Phase 2

• 3 other identifiers: ACT123392012-001369-34U1111-1127-2854
• Study Type: interventional
• Target: 32
• Locations: 5 countries
• Sites: 13

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);
• To document long term safety of SAR100842 during the extension part.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events

  Up to 8 weeks

Secondary Outcomes (3)

• Change from baseline to Week 8 in biomarkers obtained from blood and skin

  Day 1 and Week 8 (core part)

• Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)

  Day 1 and Week 8 (core part)

• Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score

  Day 1 and Week 8 (core part)

Study Arms (2)

SAR100842

EXPERIMENTAL

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

Drug: SAR100842

Placebo

PLACEBO COMPARATOR

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

Drug: SAR100842; Drug: Placebo (for SAR100842)

Interventions

SAR100842 DRUG

Pharmaceutical form: tablets Route of administration: oral

Placebo; SAR100842

Placebo (for SAR100842) DRUG

Pharmaceutical form: tablets Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (13)

Investigational Site Number 840006

Scottsdale, Arizona, 85259-5499, United States

Location

Investigational Site Number 840003

Washington D.C., District of Columbia, 20007, United States

Location

Investigational Site Number 840004

Baltimore, Maryland, 21287, United States

Location

Investigational Site Number 840001

Boston, Massachusetts, 02118, United States

Location

Investigational Site Number 840002

Ann Arbor, Michigan, 48106, United States

Location

Investigational Site Number 840007

New Brunswick, New Jersey, 08903, United States

Location

Investigational Site Number 840008

Pittsburgh, Pennsylvania, 15213, United States

Location

Investigational Site Number 250003

Lille, 59037, France

Location

Investigational Site Number 250001

Paris, 75679, France

Location

Investigational Site Number 380001

Milan, 20122, Italy

Location

Investigational Site Number 756001

Zurich, 8091, Switzerland

Location

Investigational Site Number 826001

London, United Kingdom

Location

Investigational Site Number 826002

Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.

  PMID: 29732731 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

SAR-100842

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 25, 2016

Record last verified: 2016-02

Locations

GB (2); CH (1); FR (2); IT (1); US (7)