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

December 28, 2024 updated by: Manal Hassanien, Assiut University

Upadacetinib Versus MMF in SSc-ILD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Alabama
      • Assiut, Alabama, Egypt, 7111
        • Medicinr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: upadacitinib
upadacitinib 15 mg oral once daily
Drug: Upadacitinib 15 MG
oral tablet upadacitinib
Other Names:
  • Upadacitinib
Active Comparator: MMF
MMF 2 gm oral daily
Device: Cellcept Oral Product
active control group 2000mg MMF daily
Other Names:
  • MMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced vital capacity
Time Frame: 52 week
FVC reduction of 15%
52 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High resolution chest computed tomography
Time Frame: 52 week
HRCT chest pattern changes ground glass appearance
52 week
modefided Rodnan skin score
Time Frame: 52 week
skin score for tightness grade more than 14 is worse
52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Manal Hassanien, professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

December 21, 2024

First Submitted That Met QC Criteria

December 28, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Upadacetinib in SscILD
  • Assuit university (Other Identifier: Assuit university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

allocation to which study arm and the outcome data analysis

IPD Sharing Time Frame

15 july 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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