Using Telitacicept to treat systemic sclerosis

Evaluator Blind, Controlled, Preliminary Clinical Study of Telitacicept in the Treatment of Diffuse Systemic Sclerosis With Progressive Skin Progression

This study is testing a new treatment called Telitacicept to see if it can help people with systemic sclerosis by slowing down skin thickening and improving their symptoms.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Drugs / interventions: rituximab, iparizumab, beliumab, cyclophosphamide, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT06546540 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Telitacicept, a targeted B cell therapy, in patients with systemic sclerosis, a chronic autoimmune disease. The study aims to determine how well Telitacicept can inhibit the progression of skin fibrosis and other symptoms associated with the disease. Participants must meet specific criteria, including having a confirmed diagnosis of systemic sclerosis and experiencing disease activity despite conventional treatments. The trial will monitor the effects of Telitacicept on disease progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with systemic sclerosis who have shown disease activity after conventional treatment.

Not a fit: Patients with mixed connective tissue disease, focal scleroderma, or those who are pregnant or planning to conceive may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic sclerosis.

How similar studies have performed: Previous studies on targeted B cell therapies have shown promise in treating autoimmune diseases, suggesting potential success for this approach in systemic sclerosis.

Eligibility criteria

Inclusion Criteria:

1. Subjects with systemic sclerosis who met the ACR2013 classification criteria for systemic sclerosis and approved this trial
2. Age: 18 years or older
3. Lung function FVC% \> 50%
4. Positive for ANA or scleroderma related autoantibodies
5. 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)
6. 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 equivalent) for at least 30 days

Exclusion Criteria:

1. Subjects who did not consent to participate in the clinical trial
2. Subjects with mixed connective tissue disease or overlap syndrome
3. Focal scleroderma
4. Pregnant women, lactating women and men or women who have planned to have children in the last 12 month
5. Allergic reaction: History of allergy to human derived biological products
6. 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)
7. Those who have received live vaccine in the last month
8. B cell-targeted therapies such as rituximab, iparizumab, and beliumab were used within one year
9. Tumor necrosis factor inhibitors and interleukin-receptor blockers were used within one year.
10. Patients who used intravenous gamma globulin (IVIG), prednisone ≧100 mg/d for more than 14 days within one month or underwent plasma exchange surgery
11. Use Chinese medicine for treatment within one month
12. There is active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period
13. There are serious complications such as uncontrolled congestive heart failure, arrhythmias, severe pulmonary hypertension or hypertension, severe gastrointestinal involvement, liver function impairment, active infection, severe diabetes mellitus, atherosclerotic heart disease, malignancy, AIDS, or severe peripheral vascular disease.
14. Patients with severe depression, psychosis or suicidal ideation

Where this trial is running

Beijing

• Peking Third Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jing Chai

Conditions: Systemic Sclerosis