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Tests treatment safety and results for Systemic Sclerosis
Official title The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis
ClinicalTrials.gov ID: NCT06546540
What this study is testing
What is Telitacicept?
Telitacicept is an investigational medicine, given as an once-weekly, being studied as a potential treatment for systemic sclerosis.
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
- Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. At present, there is no clear and effective drug treatment for the progression of scleroderma skin lesions, and there is a lack of authoritative treatment recommendations.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people with systemic sclerosis who met the ACR2013 classification criteria for systemic sclerosis and approved this trial
- Age: 18 years or older
- Lung function FVC% \> 50%
- Positive for ANA or scleroderma related autoantibodies
- Patients with disease activity after conventional treatment: new skin involvement or deterioration of two new body areas or skin thickening and...
You likely can't join if
- people who did not consent to participate in the clinical trial
- people with mixed connective tissue disease or overlap syndrome
- Focal scleroderma
- Pregnant women, lactating women and men or women who have planned to have children in the last 12 month
- Allergic reaction: History of allergy to human derived biological products
- Participants who had participated in any clinical trial within 28 days prior to initial screening/or within a 5-fold half-life of the study compound...
See the full eligibility criteria
- people with systemic sclerosis who met the ACR2013 classification criteria for systemic sclerosis and approved this trial
- Age: 18 years or older
- Lung function FVC% \> 50%
- Positive for ANA or scleroderma related autoantibodies
- Patients with disease activity after conventional treatment: new skin involvement or deterioration of two new body areas or skin thickening and deterioration after 6 months of conventional treatment (δMRSS ≥0 points)
- The dose of the following drugs was stable for at least 6 months before the first use of the study drug: mycophenolate mofetil, cyclophosphamide；First use of study drug precorticosteroids (≤10 mg prednisone/day or...
- people who did not consent to participate in the clinical trial
- people with mixed connective tissue disease or overlap syndrome
- Focal scleroderma
- Pregnant women, lactating women and men or women who have planned to have children in the last 12 month
- Allergic reaction: History of allergy to human derived biological products
- Participants who had participated in any clinical trial within 28 days prior to initial screening/or within a 5-fold half-life of the study compound (whichever is longer)
- Those who have received live vaccine in the last month
- B cell-targeted therapies such as rituximab, iparizumab, and beliumab were used within one year
- Tumor necrosis factor inhibitors and interleukin-receptor blockers were used within one year.
- Patients who used intravenous gamma globulin (IVIG), prednisone ≧100 mg/d for more than 14 days within one month or underwent plasma exchange surgery
- Use Chinese medicine for treatment within one month
- There is active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period
- There are serious complications such as uncontrolled congestive heart failure, arrhythmias, severe pulmonary hypertension or hypertension, severe gastrointestinal involvement, liver function impairment, active...
- Patients with severe depression, psychosis or suicidal ideation
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.