Use of Selective JAK Inhibitor in ILD and Skin Tightness... | NCT06758947

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

NCT06758947

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jan 6, 2025Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Interstitial Lung Disease Due to Systemic Disease (Disorder)

Interventions

Upadacitinib 15 MG
Cellcept Oral Product

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Assuit university	Other Identifier	Assuit university

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2023Actual

Primary Completion Date

Jun 15, 2024Actual

Completion Date

Nov 15, 2024Actual

First Submitted Date

Dec 21, 2024

First Submission Date that Met QC Criteria

Dec 28, 2024

First Posted Date

Jan 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2024

Last Update Posted Date

Jan 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manal Hassanien, Professor of Rheumatology, faculty of medicine Assuit university, Egypt, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Upadacitinib 15 MG	Drug	oral tablet upadacitinib	upadacitinib	Upadacitinib

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manal Hassanien, professor	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicinr		Asyut	Alabama	7111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

allocation to which study arm and the outcome data analysis

Types

Study Protocol

Time Frame

15 july 2025

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000613732	upadacitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided