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

NCT06758947 | Completed Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: Upadacetinib in SscILDAssuit university
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Interstitial Lung Disease Due to Systemic Disease (Disorder)

Keywords

ILD

Outcome Measures

Primary Outcomes (1)

• forced vital capacity

  FVC reduction of 15%

  52 week

Secondary Outcomes (2)

• High resolution chest computed tomography

  52 week

• modefided Rodnan skin score

  52 week

Study Arms (2)

upadacitinib

EXPERIMENTAL

upadacitinib 15 mg oral once daily

Drug: Upadacitinib 15 MG

MMF

ACTIVE COMPARATOR

MMF 2 gm oral daily

Device: Cellcept Oral Product

Interventions

Upadacitinib 15 MG DRUG

oral tablet upadacitinib

Also known as: Upadacitinib

upadacitinib

Cellcept Oral Product DEVICE

active control group 2000mg MMF daily

Also known as: MMF

MMF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Medicinr

Asyut, Alabama, 7111, Egypt

Location

MeSH Terms

Interventions

upadacitinib

Study Officials

• Manal Hassanien, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology, faculty of medicine Assuit university, Egypt

Model Details: Randomised double blinded clinical trial

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 6, 2025
• Study Start: January 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 15 july 2025

Locations

EG (1)