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

Assiut University

Status and phase: Completed; Phase 3

Conditions: Interstitial Lung Disease Due to Systemic Disease (Disorder)

Treatments: Drug: Upadacitinib 15 MG; Device: Cellcept Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06758947

Upadacetinib in SscILD

Assuit university (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

upadacitinib

Experimental group

Description:

upadacitinib 15 mg oral once daily

Treatment:

Drug: Upadacitinib 15 MG

MMF

Active Comparator group

Description:

MMF 2 gm oral daily

Treatment:

Device: Cellcept Oral Product