Effect of Telitacicept on Antibody Titers in Primary APS Patients

NCT06315530 | Completed Phase 2

• 1 other identifier: sh12053
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.

Conditions

Antiphospholipid Syndrome (APS)

Keywords

Telitacicept; Antiphospholipid Antibody Profiles

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with decreased aPL titer at week 48 of treatment

  week 48

Secondary Outcomes (2)

• new thrombotic event

  48 weeks

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

  baseline, week 12, 24, 36, 48

Other Outcomes (1)

• The incidence and severity of adverse events

  48 weeks

Study Arms (2)

Experimental: SOC+Telitacicept arm

EXPERIMENTAL

Telitacicept 160mg once a week for 48 week as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Drug: Telitacicept+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

SOC DRUG

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

Experimental: SOC arm; Experimental: SOC+Telitacicept arm

Telitacicept+SOC DRUG

160mg once a week for 48 weeks

Experimental: SOC+Telitacicept 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;
• 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.

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

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

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: March 11, 2024
• First Posted: March 18, 2024
• Study Start: December 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: January 6, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)