Actively Recruiting
Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
74
Participants Needed
46
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.
CONDITIONS
Official Title
Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosis of diffuse systemic sclerosis by American College of Rheumatology / EULAR 2013 criteria
- Diffuse systemic sclerosis according to Leroy and Medsger classification
- Disease duration less than 36 months from first non-Raynaud symptom or active disease per EUSTAR score
- Modified Rodnan skin score between 10 and 35 at screening
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use reliable contraception during the 12-month study
- Ability to provide written informed consent
- Affiliation with a social security scheme
- Stable doses of mycophenolate mofetil/sodium or methotrexate for at least 2 months if used for SSc
You will not qualify if you...
- Previous treatment with itacitinib or any Janus kinase inhibitor
- Contraindications to itacitinib or Janus kinase inhibitors
- Unable or unwilling to provide informed consent
- Participation in another investigational therapeutic study
- Acute or chronic active infections including HBV, HCV, or HIV
- Uncontrolled diseases including drug or alcohol abuse or severe psychiatric disorders
- Poor treatment adherence suspected
- White blood cell count less than or equal to 4000/mm3
- Platelet count less than or equal to 100,000/mm3
- ALT or AST levels greater than 3 times the upper limit of normal
- Triglyceride level greater than 5 g/L
- Pregnant or breastfeeding women
- Adults under legal guardianship
- Received cyclophosphamide or rituximab within last 3 months (possible inclusion beyond 3 months)
- Received biotherapy (anti-TNF, abatacept, tocilizumab) within last 3 months (possible inclusion beyond 3 months)
- Systemic lupus or Sjögren's syndrome with systemic manifestations requiring immunosuppressive therapy
- History of atherosclerotic cardiovascular disease including heart attack, ischemic stroke, or peripheral artery thrombosis
- Anti-phospholipid syndrome
AI-Screening
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Trial Site Locations
Total: 46 locations
1
CH Amiens
Amiens, France, 80000
Actively Recruiting
2
CHU Angers
Angers, France, 49100
Actively Recruiting
3
CHU Annecy
Annecy, France, 74370
Actively Recruiting
4
CHU Besançon
Besançon, France, 25030
Actively Recruiting
5
Avicenne Hospital
Bobigny, France, 93022
Actively Recruiting
6
CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
7
CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
8
Ambroise Paré hospital
Boulogne-Billancourt, France, 92100
Actively Recruiting
9
Hôpital de la Cavale Blanche
Brest, France, 29200
Actively Recruiting
10
CHU Caen
Caen, France, 14000
Actively Recruiting
11
CHU Gabriel Montpied
Clermont-Ferrand, France, 63000
Actively Recruiting
12
Henry Mondor hospital
Créteil, France, 94000
Actively Recruiting
13
CH Dax-Côte d'ARgent
Dax, France, 40100
Actively Recruiting
14
CHU Dijon
Dijon, France, 21000
Actively Recruiting
15
CHU Grenoble
Grenoble, France, 38700
Actively Recruiting
16
CHU Grenoble
Grenoble, France, 38700
Actively Recruiting
17
CH Le Mans
Le Mans, France, 72037
Actively Recruiting
18
CHU Lille
Lille, France, 59000
Actively Recruiting
19
CHU Limoges
Limoges, France, 87000
Actively Recruiting
20
CHU Lyon sud
Lyon, France, 69310
Actively Recruiting
21
Hôpital Nord
Marseille, France, 13015
Actively Recruiting
22
La Timone Hospital
Marseille, France, 13385
Actively Recruiting
23
La Timone Hospital
Marseille, France, 13385
Actively Recruiting
24
Robert Schuman Hospital
Metz, France, 57000
Actively Recruiting
25
CHU Montpellier - rhumatology
Montpellier, France, 34090
Actively Recruiting
26
CHU Montpellier - St Eloi Hospital
Montpellier, France, 34090
Actively Recruiting
27
CHU Nancy
Nancy, France, 54035
Actively Recruiting
28
CHU Nantes
Nantes, France, 44093
Actively Recruiting
29
Hopital L'Archet 1
Nice, France, 06000
Actively Recruiting
30
Hospital Pasteur - CHU Nice
Nice, France, 06000
Actively Recruiting
31
Saint Antoine Hospital
Paris, France, 75012
Not Yet Recruiting
32
La Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
33
La Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
34
Cochin Hospital
Paris, France, 75014
Actively Recruiting
35
Hospital Croix St Simon
Paris, France, 75020
Not Yet Recruiting
36
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
37
CH de Cornouaille
Quimper, France, 29000
Actively Recruiting
38
Robert Debré Hospital
Reims, France, 51100
Actively Recruiting
39
Hôpital Sud
Rennes, France, 35200
Actively Recruiting
40
CHU Rouen
Rouen, France, 76000
Not Yet Recruiting
41
CHU Saint Etienne
Saint-Etienne, France, 42000
Actively Recruiting
42
Nouvel Hospital Civil
Strasbourg, France, 67000
Actively Recruiting
43
Rangueil Hospital
Toulouse, France, 31400
Actively Recruiting
44
CHU Tours
Tours, France, 37000
Actively Recruiting
45
CH Valenciennes
Valenciennes, France, 59300
Actively Recruiting
46
Hôpitaux de Barbois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
B
Benjamin Chaigne, MD
CONTACT
A
Adèle BELLINO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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