Effect of Belimumab on Antibody Titers in Primary APS Patients

NCT06747312 | Recruiting Phase 2

• 1 other identifier: 2024136
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiphospholipid Syndrome (APS)

Keywords

Belimumab; Antiphospholipid Syndrome (APS); Antiphospholipid Antibodies

Outcome Measures

Primary Outcomes (1)

• The level of antiphospholipid antibody titers

  18 months

Secondary Outcomes (2)

• New thrombotic event

  18 months

• Effects of Belimumab on the genotype, phenotype, and functional heterogeneity of T and B cells

  18 months

Other Outcomes (1)

• The incidence and severity of adverse events

  18 months

Study Arms (2)

Experimental: SOC+Belimumab arm

EXPERIMENTAL

Belimumab 10mg/kg once a month as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Drug: Belimumab+SOC; Drug: SOC

Experimental: SOC arm

ACTIVE COMPARATOR

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Drug: SOC

Interventions

Belimumab+SOC DRUG

10mg/kg once a month for 18 months

Experimental: SOC+Belimumab arm

SOC DRUG

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Experimental: SOC arm; Experimental: SOC+Belimumab arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hui Shi, Dr

CONTACT

008613585515854; sh12053@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-07

Locations

CN (1)