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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2024-11-15

Brief Summary

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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

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Detailed Description

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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

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Interstitial Lung Disease Due to Systemic Disease (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised double blinded clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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upadacitinib

upadacitinib 15 mg oral once daily

Group Type EXPERIMENTAL

Upadacitinib 15 MG

Intervention Type DRUG

oral tablet upadacitinib

MMF

MMF 2 gm oral daily

Group Type ACTIVE_COMPARATOR

Cellcept Oral Product

Intervention Type DEVICE

active control group 2000mg MMF daily

Interventions

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Upadacitinib 15 MG

oral tablet upadacitinib

Intervention Type DRUG

Cellcept Oral Product

active control group 2000mg MMF daily

Intervention Type DEVICE

Other Intervention Names

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Upadacitinib MMF

Eligibility Criteria

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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