CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 84 target
Drug / intervention
ESG206 +3 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Primary ITP diagnosis with prior corticosteroid ± IVIG treatment
  • ✓Loss of response, insufficient response, no response, or intolerance to last ITP treatment
  • ✓Platelet count <30×10^9/L twice with ≥24 hours between tests at screening
  • ✓WHO bleeding scale 0-1
Key exclusion· 18
  • ✕Secondary immune thrombocytopenia or evidence of secondary cause
  • ✕Prior B-cell depletion therapy (e.g., rituximab, Ianalumab)
  • ✕Platelet transfusion, whole blood transfusion, plasma exchange, or rescue treatment within 14 days before first drug administration
  • ✕Splenectomy within 12 weeks before first drug administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06853444
NCT06853444Phase 2RecruitingMonitorUpdated 13mo ago · Completion was 3mo ago
Slow Enrollment
Monitor
CompareCT.gov

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)

Shanghai Escugen Biotechnology Co., Ltd·interventional·Posted Mar 3, 2025·Updated May 16, 2025

In Brief

A Phase 2 clinical trial evaluating ESG206 for Immune Thrombocytopenia (ITP). Currently recruiting, targeting 84 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia (ITP)
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
20262027
First PostedMar 3, 2025
Enrollment StartMay 8, 2025
Primary CompletionMar 31, 2026
Study CompletionApr 30, 2027
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 1.3 years ago

Interventions

ESG206drug

Administered via intravenous (IV) infusion

ESG206drug

Administered via intravenous (IV) infusion

ESG206drug

Administered via intravenous (IV) infusion

ESG206drug

Administered via intravenous (IV) infusion