A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis

NCT05300932 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: TJ-SSc202203
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Systemic Sclerosis

Keywords

Systemic Sclerosis，Baricitinib

Outcome Measures

Primary Outcomes (1)

• 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)

  24 weeks

Secondary Outcomes (11)

• Incidence of death

  24 & 48 weeks

• Incidence of Adverse Events

  24 & 48 weeks

• Incidence of Severe Adverse Events

  24 & 48 weeks

• Change in modified Rodnan skin score at 12，24，32，40，48 weeks

  12，24，32，40，48 weeks

• Proportion of patients who improved mRSS at 12，24，32，40，48 weeks

  12，24，32，40，48 weeks

Study Arms (2)

Baricitinib 4mg

EXPERIMENTAL

4mg of oral Baricitinib everyday for 48 weeks.

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.

Drug: Cyclophosphamide

Interventions

Baricitinib DRUG

Orally take Baricitinib 4mg everyday for 48 weeks

Also known as: Olumiant

Baricitinib 4mg

Cyclophosphamide DRUG

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.

Also known as: Cytoxan

Cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• )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.
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Tongji Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Eli Lilly and Company: collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Department of RheumatologyTongji Hospital

Wuhan, Hubei, 430030, China

Location

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

baricitinib; Cyclophosphamide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• AIHUA DU

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: March 8, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)