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A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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)

NCT06853444•Shanghai Escugen Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•5\. At screening, Platelet Count revealed \< 30 \* 10\^9/L twice (with an interval of at least 24 hours between the two tests).
•6\. Subjects must have adequate organ function.
•7\. The World Health Organization (WHO) bleeding scale is 0-1.
•8\. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.

Exclusion Criteria

•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).
•5\. Underwent splenectomy within 12 weeks before the first administration of the investigational drug.
•6\. Received traditional Chinese medicine treatment with definite platelet-raising effects within 1 week before the first administration of the trial drug.
•7\. Underwent major surgery within 4 weeks before the first administration of the investigational drug or needs to undergo major elective surgery during the study period.
•8\. Diagnosed with Evans syndrome or any other cytopenia (patients with mild anemia related to bleeding or iron deficiency are eligible for inclusion in the study).
•9\. Patients with current or previous life-threatening bleeding related to thrombocytopenia.
•10\. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant therapy (e.g., warfarin, clopidogrel, or new oral anticoagulants), except for low-dose acetylsalicylate (≤150 mg/day).
+11 more criteria

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Key Dates

Start Date

May 8, 2025

Primary Completion Date

March 31, 2026

Completion Date

April 30, 2027

Last Updated

May 16, 2025

Enrollment

ESTIMATED participants

Conditions

Immune Thrombocytopenia (ITP)

Interventions

ESG206

DRUG

ESG206

DRUG

ESG206

DRUG

ESG206

DRUG

Contacts

Xiaoyan Xing, PhD

CONTACT

86 21 5855 6098 xingxiaoyan@escugen.com

Ming Hou, PhD

CONTACT

86 531 82169867

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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