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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Escugen Biotechnology Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

1. Willing and able to provide written informed consent for this trial.

2. Male or female, age ≥ 18 years on the day of signing the informed consent form.

3. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.

4. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.

Disqualifiers

1. Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia, or the patient has multiple immune cytopenias.

2. Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab, etc.).

3. Received platelet transfusion or whole blood transfusion, plasma exchange, or any other rescue treatment within 14 days before the first administration of the trial drug.

4. Participated in other investigational drug clinical studies within 4 weeks before the first administration of the investigational drug or within 5 half-lives of the investigational drug received (whichever is longer).

Trial design

Treatments tested in this trial

  • ESG206
  • ESG206
  • ESG206
  • ESG206

Treatment groups

84 Participants
are divided into 4 treatment groups