NCT06758947

CompletedPhase 3

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

Assiut University Source

Assiut University ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Upadacetinib in SscILD

Secondary identifiers

Assuit university

OTHER · Assuit university

Study Type

interventional

Actual enrollment (reported)

60

Locations

1 country

Sites

1

Timeline

Study Start

January 15, 2023

Actual (reported)

Primary Completion

June 15, 2024

Actual (reported)

Study Completion

November 15, 2024

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: November 15, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 15, 2023
Actual (reported)
Primary Completion
June 15, 2024
Actual (reported)
Study Completion
November 15, 2024
Actual (reported)
First Submitted
December 21, 2024
Actual (reported)
First Posted
January 6, 2025
Actual (reported)

Last Updated: January 6, 2025
Status Verified: December 2024
Last Update Submitted: December 28, 2024

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 MGDrug

oral tablet upadacitinib

Also known as: Upadacitinib

upadacitinib

Cellcept Oral ProductDevice

active control group 2000mg MMF daily

Also known as: MMF

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Assiut University
Otherlead

Study Sites (1)

Medicinr

Asyut, Alabama, 7111, Egypt

MeSH Terms

Interventions

upadacitinib

Study Officials

Manal Hassanien, professor
Assiut University
PRINCIPAL INVESTIGATOR

Enrollment

60 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

December 21, 2024

First Posted

January 6, 2025

Study Start

January 15, 2023

Phase 3Recruiting

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Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Phase 3Active Not Recruiting

NCT06390722

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis

Phase 3Withdrawn

NCT06332534

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Phase 3Active Not Recruiting

NCT06701331

Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

Phase 3Active Not Recruiting

NCT04666675

A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Phase 3Withdrawn

NCT07772492

A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata

Phase 3Recruiting

MMF

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

Contact the study team to confirm eligibility.

Actual (reported)

Primary Completion

June 15, 2024

Actual (reported)

Study Completion

November 15, 2024

Actual (reported)

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

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06758947
Data provider: ClinicalTrials.gov
Source updated: 2025-01-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:20 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

upadacitinib

MMF

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations