NCT06853444

A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

A Phase 1/2 Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Shanghai Escugen Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase1/2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.

Detailed description

Phase 1 is a dose escalation study, and Phase 2 is an extended cohort study, subjects will be treated with ESG206. In Phase 1\&2, the study includes Screening (no more than 28 days), Treatment (14 weeks), and the post-treatment follow-up (8 weeks), for those sufferring a treatment failure, the safe follow-up will be conducted 28 days after the last dose. And the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of ESG206 in primary ITP will be assessed in this study.

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	ESG206	Administered via intravenous (IV) infusion
DRUG	ESG206	Administered via intravenous (IV) infusion
DRUG	ESG206	Administered via intravenous (IV) infusion
DRUG	ESG206	Administered via intravenous (IV) infusion

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-03-31
• Completion: 2027-04-30
• First posted: 2025-03-03
• Last updated: 2025-05-16

Locations

1 site across 1 country: China