Interstitial Lung Disease Due to Systemic Disease (Disorder)Phase 3upadacetinibNCT06758947
Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF
A Phase 3 study testing Upadacitinib 15 MG and Cellcept Oral Product in people with Interstitial Lung Disease Due to Systemic Disease (Disorder), run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Lung Disease Due to Systemic Disease (Disorder)
- What is being tested?
- Upadacitinib 15 MG and Cellcept Oral Product
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 15 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- associated other CT diseases disease duration < 3 years kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Upadacitinib 15 MG, Cellcept Oral Product
- Keywords
- ILD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib 15 MGDrug
Also called Upadacitinib
oral tablet upadacitinib
Cellcept Oral ProductDevice
Also called MMF
active control group 2000mg MMF daily
| Study group | Role | What they receive |
|---|---|---|
| upadacitinib | Experimental | upadacitinib 15 mg oral once daily Receives: Drug: Upadacitinib 15 MG |
| MMF | Active comparator | MMF 2 gm oral daily Receives: Device: Cellcept Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity
FVC reduction of 15%
Measured: 52 week
Secondary outcomes (2)
High resolution chest computed tomography
HRCT chest pattern changes ground glass appearance
Measured: 52 week
modefided Rodnan skin score
skin score for tightness grade more than 14 is worse
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Jan 2023
- Primary completion15 Jun 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease Due to Systemic Disease (Disorder)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised double blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758947
- Sponsor's protocol ID
- Upadacetinib in SscILD
- Other IDs
- Assuit university
- Acronym
- upadacetinib
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: allocation to which study arm and the outcome data analysis
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upadacetinib Versus MMF in SSc-ILD
- ClinicalTrials.gov ID
- NCT06758947
- Acronym / sponsor ID
- upadacetinib / Upadacetinib in SscILD
- Keywords
- ILD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised double blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| upadacitinib | Experimental | Drug: Upadacitinib 15 MGupadacitinib 15 mg oral once daily |
| MMF | Active comparator | Device: Cellcept Oral ProductMMF 2 gm oral daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- associated other CT diseases disease duration < 3 years kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib 15 MGAlso: Upadacitiniboral tablet upadacitinib | Drug | upadacitinib |
| Cellcept Oral ProductAlso: MMFactive control group 2000mg MMF daily | Device | MMF |
Primary outcome
forced vital capacity
Time frame: 52 week
FVC reduction of 15%
2 secondary outcomes
High resolution chest computed tomography
Time frame: 52 week
modefided Rodnan skin score
Time frame: 52 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Yes. allocation to which study arm and the outcome data analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Hassanien, professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib 15 MG and Cellcept Oral Product in people with Interstitial Lung Disease Due to Systemic Disease (Disorder), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (time frame: 52 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.