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

Sponsor
Assiut University
Study ID
NCT06758947
Phase
PHASE3
Status
Completed

Conditions

  • Interstitial Lung Disease Due to Systemic Disease (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib 15 MG — DRUG
    oral tablet upadacitinib
  • Cellcept Oral Product — DEVICE
    active control group 2000mg MMF daily

Study Details

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

Key Dates

Start date
Jan 15, 2023
Status verified
Dec 2024
Primary completion
Jun 15, 2024
Completion
Nov 15, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: upadacitinib
    upadacitinib 15 mg oral once daily
  • Active Comparator: MMF
    MMF 2 gm oral daily

Primary Outcome Measure

forced vital capacity [ Time Frame: 52 week ]

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