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Tests treatment safety and results for Systemic Sclerosis
Official title Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis
ClinicalTrials.gov ID: NCT04789850
What this study is testing
What is Itacitinib?
Itacitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient (≥18 years old)
- Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
- Patient with a diffuse SSc, according to Leroy and Medsger dichotomy
- Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc...
- Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,
You likely can't join if
- Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
- Contra-indications to itacitinib or Janus kinase inhibitor,
- Failure to sign the informed consent or unable to consent
- Patient participating in another investigational therapeutic study,
- Acute or chronic active infections, including HBV, HCV, HIV,
- Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in...
See the full eligibility criteria
- Adult patient (≥18 years old)
- Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
- Patient with a diffuse SSc, according to Leroy and Medsger dichotomy
- Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
- Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,
- Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months' duration of the study,
- Patient able to give written informed consent prior to participation in the study,
- Affiliation to a social security scheme (profit or being entitled)
- If patients receive mycophenolate or methotrexate for SSc, these need to be on stable dose as follows:
- Mycophenolate mofetil/sodium: stable dose for at least 2 months prior to randomisation
- Methotrexate: stable dose and route of administration for at least 2 months prior to randomisation
- Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
- Contra-indications to itacitinib or Janus kinase inhibitor,
- Failure to sign the informed consent or unable to consent
- Patient participating in another investigational therapeutic study,
- Acute or chronic active infections, including HBV, HCV, HIV,
- Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- Patient suspected not to be observant to the proposed treatments,
- Patient who have white blood cell count ≤ 4,000/mm3,
- Patient who have platelet count ≤ 100,000/mm3,
- Patients who have ALT or AST level greater that 3 times the upper limit of normal,
- Patient who have triglyceride level greater than 5g/L
- Pregnant or breastfeeding woman,
- Protected adults (including individual under guardianship by court order),
- Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
- Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)
- Patient with Systemic Lupus, or Sjögren's syndrome with systemic manifestations justifying immunosuppressive therapy
- Atherosclerotic cardiovascular disease as defined by a history of myocardial infarction, ischaemic stroke, or peripheral artery thrombosis
- Anti-phospholipid syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Annecy, France
- Besançon, France
- Bobigny, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Dax, France
- Dijon, France
- Grenoble, France
- Le Mans, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Metz, France
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Annecy, France; Besançon, France; Bobigny, France; Bordeaux, France and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.