Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Phase 3

Completed

• Conditions: Interstitial Lung Disease Due to Systemic Disease (Disorder)
• Interventions: Drug: Upadacitinib 15 MG; Device: Cellcept Oral Product

• Registration Number: NCT06758947
• Lead Sponsor: Assiut University

Brief Summary

Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce

Detailed Description

Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce. Upadacitinib mechanism of action JAK-STAT pathways are composed of four JAK kinases and seven STATs (STAT1-6, including homologs STAT5a and STAT5b). A cytokine binding to its receptor initiates the signaling cascade as well as the subsequent association/rearrangement of the receptor subunits. This rearrangement enables JAK activation by transphosphorylation and, upon activation, JAKs phosphorylate the receptors.

Study Timeline

• Study Start: 2023-01-15
• Primary Completion: 2024-06-15
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all patients are systemic sclerosis disease duration more than 3 years limited and diffuse types ground glass at HRCT DLCO< 80% decline in FVC >10% in last 12months

Exclusion Criteria

• associated other CT diseases disease duration < 3 years kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
upadacitinib	Upadacitinib 15 MG	upadacitinib 15 mg oral once daily
MMF	Cellcept Oral Product	MMF 2 gm oral daily

Primary Outcome Measures

Name	Time	Method
forced vital capacity	52 week	FVC reduction of 15%

Secondary Outcome Measures

Name	Time	Method
High resolution chest computed tomography	52 week	HRCT chest pattern changes ground glass appearance
modefided Rodnan skin score	52 week	skin score for tightness grade more than 14 is worse

Trial Locations

Locations (1)

Medicinr; 🇪🇬 Assiut, Alabama, Egypt