Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

Who is this study for? Patients with Systemic Sclerosis
What treatments are being studied? Itacitinib
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH Amiens
RECRUITING
Amiens
CHU Angers
RECRUITING
Angers
CHU Annecy
RECRUITING
Annecy
CHU Besançon
RECRUITING
Besançon
Avicenne Hospital
RECRUITING
Bobigny
CHU Bordeaux
RECRUITING
Bordeaux
Ambroise Paré hospital
RECRUITING
Boulogne-billancourt
Hôpital de la Cavale Blanche
RECRUITING
Brest
CHU Caen
RECRUITING
Caen
CHU Gabriel Montpied
RECRUITING
Clermont-ferrand
Henry Mondor hospital
RECRUITING
Créteil
CH Dax-Côte d'ARgent
RECRUITING
Dax
CHU Dijon
RECRUITING
Dijon
CHU Grenoble
RECRUITING
Grenoble
CH Le Mans
RECRUITING
Le Mans
CHU Lille
RECRUITING
Lille
CHU Limoges
RECRUITING
Limoges
CHU Lyon sud
RECRUITING
Lyon
Hôpital Nord
RECRUITING
Marseille
La Timone Hospital
RECRUITING
Marseille
Robert Schuman Hospital
RECRUITING
Metz
CHU Montpellier - rhumatology
RECRUITING
Montpellier
CHU Montpellier - St Eloi Hospital
RECRUITING
Montpellier
CHU Nancy
RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
Hopital L'Archet 1
RECRUITING
Nice
Hospital Pasteur - CHU Nice
RECRUITING
Nice
Cochin Hospital
RECRUITING
Paris
Hospital Croix St Simon
NOT_YET_RECRUITING
Paris
La Pitié-Salpêtrière
RECRUITING
Paris
Saint Antoine Hospital
NOT_YET_RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
CH de Cornouaille
RECRUITING
Quimper
Robert Debré Hospital
RECRUITING
Reims
Hôpital Sud
RECRUITING
Rennes
CHU Rouen
NOT_YET_RECRUITING
Rouen
CHU Saint Etienne
RECRUITING
Saint-etienne
Nouvel Hospital Civil
RECRUITING
Strasbourg
Rangueil Hospital
RECRUITING
Toulouse
CHU Tours
RECRUITING
Tours
CH Valenciennes
RECRUITING
Valenciennes
Hôpitaux de Barbois
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Benjamin Chaigne, MD
benjamin.chaigne@aphp.fr
+33 1 58 41 41 17
Backup
Adèle BELLINO
adele.bellino@aphp.fr
+33 1 58 41 11 95
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2026-02
Participants
Target number of participants: 74
Treatments
Experimental: Itacitinib
200mg of oral Itacitinib everyday for 360 days.
Placebo_comparator: Placebo
Oral placebo everyday for 360 days.
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov