NCT05998759

Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.

Detailed description

In this randomized, double-blind placebo-controlled study, the investigators aim to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia. After screening, eligible participants will be randomized at a 1: 1 ratio to receive either subcutaneous Telitacicept 160 mg or placebo once a week for 24 weeks. The background standard therapy is maintained stable during the whole treatment period.

Conditions

• Connective Tissue Diseases
• Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept	subcutaneous telitacicept 160 mg weekly for 24 weeks.
DRUG	Placebo	subcutaneous placebo weekly for 24 weeks.

Timeline

• Start date: 2023-12-02
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-08-21
• Last updated: 2025-05-06

Locations

23 sites across 1 country: China