NCT06747312 Effect of Belimumab on Antibody Titers in Primary APS Patients
| NCT ID | NCT06747312 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Antiphospholipid Syndrome (APS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-05-31 |
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 20 participants in total. It began in 2024-04-01 with a primary completion date of 2026-05-31.
⚠ 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
The purpose of this study is to evaluate the regulatory effect of Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old. * Positive for high-titer antiphospholipid antibodies according to the criteria of the "EULAR Guidelines for the Treatment of Antiphospholipid Syndrome in Adults" published in 2019. * Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome. * Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06747312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Antiphospholipid Syndrome (APS). 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 NCT06747312 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 NCT06747312 currently recruiting?
Yes, NCT06747312 is actively recruiting participants. Contact the research team at sh12053@rjh.com.cn for enrollment information.
Where is the NCT06747312 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06747312 clinical trial?
NCT06747312 is sponsored by Ruijin Hospital. The trial plans to enroll 20 participants.