Systemic SclerosisPhase 4NCT05300932
A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis
A Phase 4 study testing Baricitinib and Cyclophosphamide in people with Systemic Sclerosis, run by Tongji Hospital at 2 sites in China.
Trial summary
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Baricitinib and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 8 Mar 2022to 12 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
- Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
- Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
- For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit
- For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:
- 1)Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months 2)Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months 3)Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months 4)Presence of 1 or more Tendon Friction Rub 6.Age ≥ 18 years at the screening visit 7.If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits 8.Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for 2 weeks prior to and including the baseline visit.
- 9.ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.
Who cannot join
- Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
- Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
- Major surgery (including joint surgery) within 8 weeks prior to screening visit
- Infected ulcer prior to treatment
- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
- Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
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- Anti-CD20 within 12 months prior to baseline visit.
- Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit
- Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
- Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit
- Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit
- Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit
- Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit
- Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.
- Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
- Positive for hepatitis B surface antigen prior to the baseline visit
- Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
- Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
- Any of the following at the screening visit: Hemoglobin <8 g/dL; ANC < 1,000/mm3 (<1 x 109/L); platelets < 100,000/mm3 (<100 x 109/L); serum creatinine > 2 x ULN; serum ALT or AST > 2 x ULN
- Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen
- Patients with a history of anaphylaxis to Baricitinib or cyclophosphamide
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of RheumatologyTongji Hospital
Wuhan, Hubei, 430030
Tongji Hospital
Wuhan, Hubei, 430030
About this study
Official title: Efficacy and Safety of Baricitinib in Systemic Sclerosis: a Phase IV, Double-blinded, Controlled Study.
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase.
Read the detailed description
This is a 48 weeks, prospective, double-blind, controlled study. The specific objectives of this study are to:
- Determine whether Baricitinib is effective and safe in the treatment of patients with diffuse cutaneous (dc)SSc when compared to patients treated with CTX. In this study, stand of care of GC is permitted to use.
- Determine whether Baricitinib is more effective than CTX, as measured by change in CRISS, which is a composite outcome measure provisionally endorsed by the ACR for scleroderma clinical trials. It incorporates change in the mRSS, FVC percent predicted, physician and patient global assessments, and HAQ-DI. Additionally, hemoglobin corrected diffusion capacity (DLCO), Medsger Severity Scale (MSS), and by other physician and patient derived outcome measures will be used.
- Determine the biological activity of Baricitinib vs CTX as assessed by effect on histology of skin, gene expression of skin and blood, change in B-Cell profiles including assessment of B regulatory cells, and effect on serological and cutaneous biomarkers of disease activity.
- Conditions
- Systemic Sclerosis
- Being tested
- Baricitinib, Cyclophosphamide
- Keywords
- Systemic Sclerosis，Baricitinib
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant
Orally take Baricitinib 4mg everyday for 48 weeks
CyclophosphamideDrug
Also called Cytoxan
Subject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib 4mg | Experimental | 4mg of oral Baricitinib everyday for 48 weeks. Receives: Drug: Baricitinib |
| Cyclophosphamide | Active comparator | Subject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Rodnan skin score (mRSS) at week 24
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0.
To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Measured: 24 weeks
Secondary outcomes (11)
Incidence of death
Incidence of death
Measured: 24 & 48 weeks
Incidence of Adverse Events
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Measured: 24 & 48 weeks
Incidence of Severe Adverse Events
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Measured: 24 & 48 weeks
Change in modified Rodnan skin score at 12，24，32，40，48 weeks
Change in modified Rodnan skin score at 12，24，32，40，48 weeks
Measured: 12，24，32，40，48 weeks
Proportion of patients who improved mRSS at 12，24，32，40，48 weeks
Proportion of patients who improved mRSS at 12，24，32，40，48 weeks
Measured: 12，24，32，40，48 weeks
Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR)SSc activity score at 12，24，48 weeks
EUSTAR SSc activity index score from 0 to 10 - a cut-off ≥ 2.5 identifies patients with active disease
Measured: 12，24，32，40，48 weeks
Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
composite response index
Measured: 24，48 weeks
SSc disease activity
Physicians visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity Patients visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
Measured: 12，24，32，40，48 weeks
Short Form-36 (SF-36) health questionnaire
self-administered questionnaire of 36 items assessing the following 8 domains : physical functioning, bodily pain, role limitations attributable to physical health problems, general health perceptions, mental health, role limitations to emotional problems, vitality and social functioning (scale from 0 to 100)
Measured: 0, 12，24，32，40，48 weeks
EurolQol-5Domain (EQ-5D) health questionnaire
self reported measure of quality of life - (scale from 0 to 100)
Measured: 0, 12，24，32，40，48 weeks
Health Assessment Questionnaire Disability Index (HAQ-DI) scale
self administered 20 questions- score range from 0 (no disability) to 3 (severe disability)
Measured: 0, 12，24，32，40，48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start8 Mar 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, Eli Lilly and Company, Johns Hopkins University
- Responsible party
- Principal investigator, YIKAI YU, Tongji Hospital
- Investigators
- AIHUA DU, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300932
- Sponsor's protocol ID
- TJ-SSc202203
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Baricitinib in Systemic Sclerosis: a Phase IV, Double-blinded, Controlled Study.
- ClinicalTrials.gov ID
- NCT05300932
- Acronym / sponsor ID
- TJ-SSc202203
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic Sclerosis，Baricitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, Eli Lilly and Company, Johns Hopkins University
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 29 Mar 2022 (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 rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase.
Detailed description
This is a 48 weeks, prospective, double-blind, controlled study. The specific objectives of this study are to:
- Determine whether Baricitinib is effective and safe in the treatment of patients with diffuse cutaneous (dc)SSc when compared to patients treated with CTX. In this study, stand of care of GC is permitted to use.
- Determine whether Baricitinib is more effective than CTX, as measured by change in CRISS, which is a composite outcome measure provisionally endorsed by the ACR for scleroderma clinical trials. It incorporates change in the mRSS, FVC percent predicted, physician and patient global assessments, and HAQ-DI. Additionally, hemoglobin corrected diffusion capacity (DLCO), Medsger Severity Scale (MSS), and by other physician and patient derived outcome measures will be used.
- Determine the biological activity of Baricitinib vs CTX as assessed by effect on histology of skin, gene expression of skin and blood, change in B-Cell profiles including assessment of B regulatory cells, and effect on serological and cutaneous biomarkers of disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib 4mg | Experimental | Drug: Baricitinib4mg of oral Baricitinib everyday for 48 weeks. |
| Cyclophosphamide | Active comparator | Drug: CyclophosphamideSubject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
- Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
- Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
- For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit
- For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:
Key exclusion criteria (21 listed)
- Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
- Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
- Major surgery (including joint surgery) within 8 weeks prior to screening visit
- Infected ulcer prior to treatment
- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
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 |
|---|---|---|
| BaricitinibAlso: OlumiantOrally take Baricitinib 4mg everyday for 48 weeks | Drug | Baricitinib 4mg |
| CyclophosphamideAlso: CytoxanSubject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period. | Drug | Cyclophosphamide |
Primary outcome
Change in modified Rodnan skin score (mRSS) at week 24
Time frame: 24 weeks
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
11 secondary outcomes
Incidence of death
Time frame: 24 & 48 weeks
Incidence of Adverse Events
Time frame: 24 & 48 weeks
Incidence of Severe Adverse Events
Time frame: 24 & 48 weeks
Change in modified Rodnan skin score at 12，24，32，40，48 weeks
Time frame: 12，24，32，40，48 weeks
Proportion of patients who improved mRSS at 12，24，32，40，48 weeks
Time frame: 12，24，32，40，48 weeks
Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR)SSc activity score at 12，24，48 weeks
Time frame: 12，24，32，40，48 weeks
Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
Time frame: 24，48 weeks
SSc disease activity
Time frame: 12，24，32，40，48 weeks
Short Form-36 (SF-36) health questionnaire
Time frame: 0, 12，24，32，40，48 weeks
EurolQol-5Domain (EQ-5D) health questionnaire
Time frame: 0, 12，24，32，40，48 weeks
Health Assessment Questionnaire Disability Index (HAQ-DI) scale
Time frame: 0, 12，24，32，40，48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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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.
AIHUA DU study chair
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baricitinib and Cyclophosphamide in people with Systemic Sclerosis, run by Tongji Hospital at 2 sites in China.
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 7 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in modified Rodnan skin score (mRSS) at week 24 (time frame: 24 weeks). 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 27 Jan 2026.