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Tests treatment safety and results for Diffuse Cutaneous Systemic Sclerosis
Official title Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
ClinicalTrials.gov ID: NCT06375005
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Also referred to as Taiai for commercial name.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Men or women aged 18-70 years old.
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
- ≥ 10 mRSS units at the screening visit.
You likely can't join if
- Limited scleroderma.
- Disease duration of greater than 3 years.
- Rheumatic autoimmune disease other than SSc.
- Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.
- Any prior history of renal crisis.
- Intermediate- or high-risk pulmonary arterial hypertension.
See the full eligibility criteria
- Men or women aged 18-70 years old.
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
- ≥ 10 mRSS units at the screening visit.
- Negative serum pregnancy test in a woman of childbearing potential at the screening visit.
- Ability to render informed consent in accordance with institutional guidelines.
- Limited scleroderma.
- Disease duration of greater than 3 years.
- Rheumatic autoimmune disease other than SSc.
- Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.
- Any prior history of renal crisis.
- Intermediate- or high-risk pulmonary arterial hypertension.
- Pulmonary disease with FVC \< 50% of predicted or DLCO (hemoglobin-corrected) \< 40% of predicted at screening or requires oxygen therapy.
- Underwent major surgery within 8 weeks prior to randomization or planned major surgery during the trial period.
- Use of immunosuppressive therapies, including methotrexate, azathioprine, hydroxychloroquine, leflunomide, tacrolimus, sirolimus, and mycophenolate mofetil within 4 weeks prior to randomization, and cyclophosphamide...
- Use of other anti-fibrotic agents, including colchicine, D-penicillamine, thalidomide, nintedanib, pirfenidone, tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib) within 4 weeks prior to randomization.
- Use of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily, or intravenous and intramuscular corticosteroid injections within 4 weeks prior to randomization.
- Use of Intravenous Immunoglobulin (IVIG) within 12 weeks within 4 weeks prior to randomization.
- Prior use of belimumab, rituximab, or other B-Cell depleting therapies ever.
- Use of other biologics or small molecule targeted therapies, including anakinra within 1 week prior to randomization, ixekizumab within 2 weeks prior to randomization, and infliximab, certolizumab pegol, golimumab...
- Prior use of other cell depletion therapies.
- Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as severe central nervous system disease，severe heart failure, arrhythmia, unstable...
- Abnormal results in hepatitis B or hepatitis C testing indicating active or chronic infection.
- Active tuberculosis (TB) or latent TB infection.
- Seropositive for human immunodeficiency virus (HIV) or known history of HIV infection.
- Known active bacterial, viral, fungal, mycobacterial, or other infection，including major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics...
- Primary or secondary immunodeficiency.
- IgA deficiency (\<10 mg/dL) or IgG deficiency (\<400 mg/dL).
- Participation in another clinical research study involving the evaluation of another investigational drug within 3 months of entry into this study.
- Any of the following at the screening visit: Hemoglobin \ 1.5 x ULN; TBil \> ULN; eGFR \< 40mL/min/1.73m\^2.
- Malignant disease within 5 years prior to screening, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix;
- Immunization with a live/attenuated vaccine within 4 weeks prior to randomization.
- Pregnant or breast feeding women or women of childbearing potential not willing to use adequate contraception.
- History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- Immunization with a live/attenuated vaccine within 4 weeks prior to randomization.
- Patients anticipated to be non-compliant with the protocol requirements or expected not to complete the trial as planned (e.g., those with psychiatric disorders, history of alcohol abuse, drug abuse, or substance...
The study team makes the final eligibility decision.
Where it's taking place
- Yangzhou, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Huzhou, Zhejiang, China
- Jiaxing, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yangzhou, Jiangsu, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China; Huzhou, Zhejiang, China; Jiaxing, Zhejiang, China; Ningbo, Zhejiang, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.