Systemic SclerosisPhase 2NCT01651143
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
A Phase 2 study testing SAR100842 in people with Systemic Sclerosis, run by Sanofi at 13 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- SAR100842
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States7 sites
Investigational Site Number 840002
Ann Arbor, Michigan, 48106
Investigational Site Number 840004
Baltimore, Maryland, 21287
Investigational Site Number 840001
Boston, Massachusetts, 02118
Investigational Site Number 840007
New Brunswick, New Jersey, 08903
Investigational Site Number 840008
Pittsburgh, Pennsylvania, 15213
Investigational Site Number 840006
Scottsdale, Arizona, 85259-5499
Investigational Site Number 840003
Washington D.C., District of Columbia, 20007
France2 sites
Investigational Site Number 250003
Lille, 59037
Investigational Site Number 250001
Paris, 75679
United Kingdom2 sites
Investigational Site Number 826001
London
Investigational Site Number 826002
Salford, M6 8HD
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Systemic Sclerosis
- Being tested
- SAR100842, Placebo (for SAR100842)
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR100842Drug
Pharmaceutical form: tablets
Route of administration: oral
Placebo (for SAR100842)Drug
Pharmaceutical form: tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SAR100842; Drug: Placebo (for SAR100842) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events
Measured: Up to 8 weeks
Secondary outcomes (3)
Change from baseline to Week 8 in biomarkers obtained from blood and skin
Measured: Day 1 and Week 8 (core part)
Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)
Measured: Day 1 and Week 8 (core part)
Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score
Measured: Day 1 and Week 8 (core part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651143
- Sponsor's protocol ID
- ACT12339
- Other IDs
- 2012-001369-34, U1111-1127-2854
- Status last verified
- Feb 2016
- First submitted
- 24 Jul 2012
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29732731
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01651143
- Acronym / sponsor ID
- ACT12339
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR100842 | Experimental | Drug: SAR100842Core part: SAR100842 300 mg, oral administration twice daily, for 8 weeks Extension part: SAR100842 300 mg, oral administration twice daily, for 16 additional weeks |
| Placebo | Placebo comparator | Drug: SAR100842, Drug: Placebo (for SAR100842)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR100842Pharmaceutical form: tablets Route of administration: oral | Drug | Placebo, SAR100842 |
| Placebo (for SAR100842)Pharmaceutical form: tablets Route of administration: oral | Drug | Placebo |
Primary outcome
Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events
Time frame: Up to 8 weeks
3 secondary outcomes
Change from baseline to Week 8 in biomarkers obtained from blood and skin
Time frame: Day 1 and Week 8 (core part)
Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)
Time frame: Day 1 and Week 8 (core part)
Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score
Time frame: Day 1 and Week 8 (core part)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Derived from this study: PubMed 29732731Allanore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR100842 in people with Systemic Sclerosis, run by Sanofi at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, United Kingdom, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.