NCT06375005 Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
| NCT ID | NCT06375005 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Diffuse Cutaneous Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-01-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2025-01-06 with a primary completion date of 2027-01-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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 within 3 months prior to randomization. * 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, adalimumab, abatacept, tocilizumab within 8 weeks prior to randomization, and janus kinase inhibitors within 2 weeks prior to randomization. * 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 atherosclerotic cardiovascular disease, severe GI involvement, severe hypertension or severe diabetes. * 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 within 2 weeks prior to screening. * 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 \<8.0 g/dL; WBC \<3 x 10\^9/L; Neutrophil \<1.5 x 10\^9/L; platelets \<75 x 10\^9/L; serum ALT or AST \> 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 misuse).
Contact & Investigator
JING XUE, PhD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT06375005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diffuse Cutaneous Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06375005 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06375005 currently recruiting?
Yes, NCT06375005 is actively recruiting participants. Contact the research team at jingxue@zju.edu.cn for enrollment information.
Where is the NCT06375005 trial being conducted?
This trial is being conducted at Yangzhou, China, Shanghai, China, Hangzhou, China, Hangzhou, China and 5 additional locations.
Who is sponsoring the NCT06375005 clinical trial?
NCT06375005 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is JING XUE, PhD at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 38 participants.