What is ESG206 studying for primary immune thrombocytopenia (ITP)?

ESG206 is being studied to evaluate its safety, tolerability, how it behaves in the body, immune effects, and early signs of benefit in patients with primary immune thrombocytopenia. The trial aims to understand how this antibody treatment works in patients who have not responded well to previous therapies. It is sponsored by Shanghai Escugen Biotechnology Co., Ltd.

Who may be eligible for this primary immune thrombocytopenia clinical trial?

Adults aged 18 years or older diagnosed with primary immune thrombocytopenia who have previously been treated with corticosteroids with or without intravenous immunoglobulin may be eligible. Participants must have a low platelet count and adequate organ function, and both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this primary immune thrombocytopenia clinical trial?

Study-related care, including the study drug ESG206 and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside the study services.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06853444

Phase 12 Study of ESG206 Given by IV Infusion for Safety and Effectiveness in Adults With Primary Immune Thrombocytopenia

Led by Shanghai Escugen Biotechnology Co., Ltd · Updated on 2025-05-16

Participants Needed

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ESG206, an anti-BAFF-R monoclonal antibody, in patients with primary immune thrombocytopenia ITP to study its safety, tolerability, how the body processes the drug, immune response, and early signs of effectiveness. This Phase 12 open-label study is designed to understand these aspects in patients who have experienced insufficient or no response to prior ITP treatments such as corticosteroids and intravenous immunoglobulin. The study includes a dose escalation phase and an extended cohort phase where participants receive ESG206 intravenously at one of four different dose levels. The trial consists of a screening period of up to 28 days, followed by a 14-week treatment phase, and an 8-week post-treatment follow-up. Participants who experience treatment failure will undergo an additional safety follow-up 28 days after their last dose. During the study, participants will have their safety closely monitored, including tracking any adverse events, and their response to treatment evaluated by measuring platelet counts and immune cell levels over 24 weeks. Pharmacokinetic and pharmacodynamic assessments, immunogenicity testing, and other laboratory evaluations will be performed to understand the drugs effects. The total participation time includes screening, treatment, and follow-up periods, with regular visits for assessments and monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Willing and able to provide written informed consent for this trial.
Male or female, age 18 years or older at the time of consent.
Diagnosed with primary immune thrombocytopenia (ITP) and previously treated with corticosteroids with or without intravenous immunoglobulin (IVIG).
Experienced loss of response, insufficient response, no response, or intolerance to last ITP treatment.
Platelet count less than 30 × 10^9/L on two tests at least 24 hours apart during screening.
Adequate organ function.
World Health Organization (WHO) bleeding scale score of 0-1.
Fertile men and women of reproductive age must agree to use effective contraception from consent until 180 days after last dose; women must have a negative pregnancy test within 7 days before first dose.

You will not qualify if you...

Diagnosed with secondary immune thrombocytopenia or evidence of secondary causes, or multiple immune cytopenias.
Previously received B-cell depletion therapy such as rituximab or Ianalumab.
Received platelet or whole blood transfusion, plasma exchange, or other rescue treatments within 14 days before first dose.
Participated in other investigational drug studies within 4 weeks or within 5 half-lives of prior investigational drug.
Underwent splenectomy within 12 weeks before first dose.
Received traditional Chinese medicine with platelet-raising effects within 1 week before first dose.
Underwent major surgery within 4 weeks before first dose or requires major elective surgery during study.
Diagnosed with Evans syndrome or other cytopenias except mild anemia related to bleeding or iron deficiency.
History of life-threatening bleeding related to thrombocytopenia.
Concurrent coagulation disorders or use of antiplatelet or anticoagulant drugs except low-dose aspirin (≤150 mg/day).
Deep vein or arterial thrombosis within 6 months or hereditary thrombophilia risk factors.
History of severe cardiovascular or pulmonary disease.
Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg).
HIV infection, active hepatitis B or C, or liver cirrhosis.
Active infections requiring systemic treatment or history of significant recurrent infections.
Received live or attenuated vaccines within 4 weeks before first dose.
History or current malignant tumors except certain cured cancers or cancers in remission for 3+ years.
Severe or unstable medical, mental, or other conditions interfering with study.
Known hypersensitivity to monoclonal antibodies or trial drug components.
Pregnant or lactating women.
Unwilling or unable to follow study procedures.

Research Team

Xiaoyan Xing, PhD

Ming Hou, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 12 Study of ESG206 Given by IV Infusion for Safety and Effectiveness in Adults With Primary Immune Thrombocytopenia

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria