Actively Recruiting
Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-11
38
Participants Needed
9
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.
CONDITIONS
Official Title
Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18-70 years old
- Diagnosis of systemic sclerosis according to ACR/EULAR 2013 criteria
- Diffuse cutaneous systemic sclerosis (dcSSc) as defined by LeRoy criteria
- Disease duration of 18 months or less from first non-Raynaud's symptom
- Modified Rodnan Skin Score (mRSS) of 10 or higher at screening
- Negative pregnancy test for women of childbearing potential at screening
- Ability to provide informed consent according to institutional guidelines
You will not qualify if you...
- Limited scleroderma diagnosis
- Disease duration greater than 3 years
- Presence of other rheumatic autoimmune diseases besides systemic sclerosis
- Systemic sclerosis-like illness caused by environmental agents such as vinyl chloride or bleomycin
- History of renal crisis
- Intermediate or high-risk pulmonary arterial hypertension
- Pulmonary disease with forced vital capacity (FVC) less than 50% predicted or DLCO less than 40% predicted or requiring oxygen therapy
- Major surgery within 8 weeks before randomization or planned during the study
- Use of immunosuppressive therapies (methotrexate, azathioprine, hydroxychloroquine, leflunomide, tacrolimus, sirolimus, mycophenolate mofetil) within 4 weeks before randomization or cyclophosphamide within 3 months
- Use of anti-fibrotic agents (colchicine, D-penicillamine, thalidomide, nintedanib, pirfenidone, tyrosine kinase inhibitors) within 4 weeks before randomization
- Use of corticosteroids above prednisone 10 mg daily or intravenous/intramuscular corticosteroids within 4 weeks before randomization
- Use of intravenous immunoglobulin (IVIG) within 12 weeks before randomization
- Prior use of B-cell depleting therapies such as belimumab or rituximab
- Use of other biologics or small molecule targeted therapies within specified time frames before randomization
- Prior use of other cell depletion therapies
- Serious concurrent medical conditions making participation inappropriate
- Active or chronic hepatitis B or C infection
- Active or latent tuberculosis infection
- HIV positive or history of HIV infection
- Active bacterial, viral, fungal, mycobacterial, or other infections including recent severe infections requiring hospitalization or antibiotics
- Primary or secondary immunodeficiency
- IgA deficiency less than 10 mg/dL or IgG deficiency less than 400 mg/dL
- Participation in another investigational drug study within 3 months
- Blood abnormalities at screening including low hemoglobin, white blood cells, neutrophils, platelets, elevated liver enzymes, bilirubin, or low estimated glomerular filtration rate
- Malignancy within 5 years except certain skin or cervical cancers
- Live or attenuated vaccine within 4 weeks before randomization
- Pregnant or breastfeeding women or women not willing to use contraception
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Anticipated non-compliance with study requirements
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China, 225009
Actively Recruiting
2
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
3
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
4
Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
5
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
6
Changxing People's Hospital
Huzhou, Zhejiang, China, 313100
Actively Recruiting
7
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China, 314000
Actively Recruiting
8
Ningbo First Hospital
Ningbo, Zhejiang, China, 315000
Actively Recruiting
9
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
J
JING XUE, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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