Actively Recruiting
A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia
Led by Shanghai Escugen Biotechnology Co., Ltd · Updated on 2025-05-16
84
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia
Who Can Participate
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.
- 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 at the time of last ITP treatment.
- Platelet count less than 30 x 10^9/L on two tests at least 24 hours apart at screening.
- Adequate organ function.
- World Health Organization (WHO) bleeding scale of 0-1.
- Fertile men and women of reproductive age 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 multiple immune cytopenias.
- Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab).
- Received platelet or whole blood transfusion, plasma exchange, or rescue treatment within 14 days before first dose.
- Participated in other investigational drug studies within 4 weeks or 5 half-lives of investigational drug before first dose.
- 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 on antiplatelet/anticoagulant therapy except low-dose aspirin (≤150 mg/day).
- Deep vein or arterial thrombosis within 6 months before enrollment or hereditary thrombophilia risk.
- History of severe cardiovascular or pulmonary diseases.
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg).
- HIV infection, active hepatitis B or C, or liver cirrhosis.
- Active infections requiring systemic treatment during screening or history of significant recurrent infections.
- Received live or attenuated live vaccines within 4 weeks before first dose.
- History or current malignant tumors except certain cured or in remission cancers.
- Severe or unstable medical, mental, or other conditions interfering with study participation.
- Known hypersensitivity to monoclonal antibodies or trial drug components.
- Pregnant or lactating women.
- Unwilling or unable to follow protocol procedures.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
X
Xiaoyan Xing, PhD
CONTACT
M
Ming Hou, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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