Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease

Systemic Sclerosis Clinical Trial

— SCLEROJAKI  

Official title:

Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177471
• Other study ID #: 2021PI233
• Status: Recruiting
• Start date: January 19, 2022
• Est. completion date: July 4, 2024

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Paul DECKER, MD
• Phone: +33383157240
• Email: p.decker[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality.

Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis.

Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis.

The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 4, 2024
• Est. primary completion date: July 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with systemic sclerosis according to 2013 ACR/EULAR criteria

• Patients with interstitial lung disease affecting at least 10 % of the lungs on HRCT chest, FVC of at least 40 % of the predicted value and DLCO between 30 % and 90 % of the predicted value

• Use of JAK inhibitors

Exclusion Criteria:

• Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

• Patients with pulmonary arterial hypertension defined on right heart catheterization

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
France	CHU Nancy	Vandœuvre-lès-Nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative change in FVC after 12 months of JAK inhibitor	relative change in %predicted FVC after 12 months of JAK inhibitor	at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Secondary	relative change in DLCO after 12 months of JAK inhibitor	relative change in %predicted DLCO after 12 months of JAK inhibitor	at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Secondary	relative change in skin fibrosis after 12 months of JAK inhibitor	relative change in modified Rodnan skin score after 12 months of JAK inhibitor	at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation