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The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-11
38
Participants Needed
9
Research Sites
51 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of Telitacicept combined with Mycophenolate Mofetil (MMF) in adults diagnosed with early diffuse cutaneous systemic sclerosis (dcSSc). The study is a prospective, open-label, randomized, controlled, multi-center clinical trial focusing on patients with this specific form of systemic sclerosis. Participants in this trial will all receive MMF orally at 0.5 grams twice daily for 48 weeks as background treatment. In addition, one group will receive weekly subcutaneous injections of Telitacicept at a dose of 160 mg for 48 weeks. The study compares the combination therapy against MMF alone over this treatment period. Throughout the 48 weeks of treatment, participants will undergo assessments including the Modified Rodnan Skin Score (mRSS) to measure skin thickness and other evaluations such as lung function tests and patient and physician health assessments. Safety will be monitored through tracking adverse events up to week 52. The total participation duration includes treatment and follow-up to observe both efficacy and safety outcomes.
CONDITIONS
Brief 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 as defined by LeRoy criteria
- Disease duration of 18 months or less from first non-Raynaud's symptom
- Modified Rodnan Skin Score of 10 or more at screening
- Negative pregnancy test for women of childbearing potential
- Ability to provide informed consent according to institutional guidelines
You will not qualify if you...
- Limited scleroderma
- Disease duration longer than 3 years
- Other rheumatic autoimmune diseases besides systemic sclerosis
- Systemic sclerosis-like illness caused by environmental agents
- History of renal crisis
- Moderate to high risk pulmonary arterial hypertension
- Pulmonary disease with 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 trial
- Use of specified immunosuppressive or anti-fibrotic therapies within defined timeframes before randomization
- Use of corticosteroids exceeding prednisone 10 mg daily or recent injections
- Prior use of B-cell depleting therapies or certain biologics
- Serious concurrent medical conditions like severe CNS disease, heart failure, arrhythmia, severe GI involvement, hypertension, or diabetes
- Active or chronic hepatitis B or C infection
- Active or latent tuberculosis infection
- HIV positive or known history of HIV infection
- Active infections requiring recent antibiotic or hospitalization treatment
- Primary or secondary immunodeficiency
- IgA or IgG deficiency
- Participation in another investigational drug study within 3 months
- Abnormal blood counts or liver/kidney function beyond specified limits
- Recent malignant disease except certain treated skin or cervical cancers
- Recent immunization with live/attenuated vaccines
- Pregnant or breastfeeding women or unwillingness to use contraception
- History of allergic reactions to monoclonal antibodies
- Expected non-compliance or inability to complete the trial as planned due to psychiatric or substance issues
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 48 weeks
Participants receive treatment with Mycophenolate Mofetil (MMF) taken orally twice daily and, for some, Telitacicept injected weekly. Treatment lasts for 48 weeks.
Weekly visits for injections and assessments during treatment
Duration - 4 weeks
Participants are monitored for safety and treatment-related effects after the treatment period ends.
1 visit approximately 4 weeks after treatment completion
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
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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