NCT06758947

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

Upadacetinib Versus MMF in SSc-ILD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Lung Disease Due to Systemic Disease (Disorder)

Interventions

Type	Name	Description
DRUG	Upadacitinib 15 MG	oral tablet upadacitinib
DEVICE	Cellcept Oral Product	active control group 2000mg MMF daily

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-06-15
• Completion: 2024-11-15
• First posted: 2025-01-06
• Last updated: 2025-01-06

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study