Evaluating Telitacicept's effect on antibody levels in patients with Antiphospholipid Syndrome

A Single Center, Randomized Controlled, Open Label Trial Exploring the Regulatory Effect of Telitacicept on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying High-risk Antiphospholipid Antibody Profiles

This study is testing if adding a new treatment called Telitacicept to standard care can help lower antibody levels in patients with high-risk antiphospholipid syndrome.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: rituximab, epratuzumab, prednisone
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06315530 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the impact of Telitacicept on antibody titers in patients diagnosed with primary antiphospholipid syndrome (APS) who have high-risk antiphospholipid antibody profiles. It is a single-center, randomized controlled trial conducted at Ruijin Hospital, where participants will be randomly assigned to receive either standard of care plus Telitacicept or standard of care alone. Telitacicept will be administered subcutaneously at a dose of 160mg once a week for a duration of 48 weeks. The study seeks to determine if this treatment can effectively regulate antibody levels in these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with primary APS who meet specific high-risk antiphospholipid antibody criteria.

Not a fit: Patients with other concurrent autoimmune diseases or those who do not meet the high-risk antiphospholipid antibody criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved management of antibody levels in patients with Antiphospholipid Syndrome, potentially reducing the risk of associated complications.

How similar studies have performed: While there is ongoing research in this area, the specific use of Telitacicept for this patient population is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* Diagnosis of primary APS, meet 2006 Sydney classification criteria or continuously positive for antiphospholipid antibodies within the first 12 months of inclusion (tested at least every 12 weeks), classified as high-risk antiphospholipid antibody spectrum based on the risk of antibody levels, in order to meet at least one of the following conditions: 1. Positive lupus anticoagulant (LAC) (tested according to ISTH guidelines); 2. Two or three types of aPL positivity (lupus anticoagulant, anticardiolipin antibody, and anti-β2 any two or all three types of glycoprotein I antibodies; 3. Or persistent high titer aPL;
* There are no other autoimmune diseases occurring simultaneously;
* According to EULAR recommendations for antiphospholipid syndrome, a stable APS treatment regimen should be adopted;
* Female patients who are not pregnant, breastfeeding, have no fertility potential, or have not undergone contraception.

Exclusion Criteria:

* Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years;
* Patients with a history of primary immunodeficiency;
* Serious lack of IgG (IgG level \< 400 mg/dL);
* IgA deficiency (IgA level \< 10 mg/dL);
* Patients with a current history of infection;
* Patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or dependence within 365 days before day 0;
* HIV test is historically positive or HIV screening is positive;
* Hepatitis status;
* Patients with a history of allergic reaction caused by injection of contrast agent, human or mouse protein or monoclonal antibody;
* Patients with other abnormal laboratory values with clinical significance;
* If women with reproductive potential (WCBP) are included, please refer to the following special instructions;
* Patients with concurrent major medical or mental illnesss;
* Patients with diseases of liver, kidney, heart and other important organs,blood and Endocrine system;
* Patients who have been vaccinated with live vaccine in the last month;
* Patients who have participated in any clinical trial within 28 days before the initial screening and/or within 5 times of the half-life of the study compound (whichever is longer);
* Patients who use B-cell targeted therapy drugs within one year, such as rituximab or epratuzumab;
* Patients who use tumor necrosis factor inhibitor and interleukin receptor blocker within one year;
* Patients who use Intravenous gamma globulin (IVIG) and prednisone ≥100mg/d for more than 14 days within one year or plasma exchange;
* Patients with active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period;
* Patients with depression or suicidal thoughts;
* Other conditions that the investigator considers would make the candidate unsuitable for the study.

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Chengde Yang, Dr

Conditions: Antiphospholipid Syndrome, Telitacicept, Antiphospholipid Antibody Profiles