Immune Thrombocytopenia (ITP)Phase 1/2NCT06853444
A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia
A Phase 1/2 study testing ESG206 in people with Immune Thrombocytopenia (ITP), run by Shanghai Escugen Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- ESG206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2025to 30 Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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. Patients with deep vein thrombosis or arterial thrombosis within 6 months before enrollment, and/or with risk factors for hereditary thrombophilia.
- 12. Patients with a history of severe cardiovascular and pulmonary diseases.
- 13. Patients with uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- 14. Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or liver cirrhosis.
- 15. Patients with active viral, bacterial, or other infections requiring systemic treatment during the screening period, or with a history of clinically significant recurrent infections (e.g., bacterial infection with capsule). Patients with a history of tuberculosis (TB) or latent TB who have undergone anti-TB treatment may be eligible for inclusion.
- 16. Patients who received live or attenuated live vaccines within 4 weeks before the first administration of the investigational drug.
- 17. Patients with a history of or current malignant tumors, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical cancer, breast cancer, bladder cancer, prostate cancer), and cancers that have been in complete remission for at least 3 years without evidence of recurrence.
- 18. Patients with any severe and/or unstable pre-existing medical, mental, or other conditions that the investigator deems may interfere with the patient's efficacy, safety, informed consent, or compliance with the study procedures.
- 19. Patients with known immediate or delayed hypersensitivity reactions to monoclonal antibodies or components of the trial drug, or with a history of allergic constitution.
- 20. Pregnant or lactating women.
- 21. Patients who are unwilling or unable to follow the protocol procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ming Hou, PhD contact
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Ming Hou, PhD, 86 531 82169867, houming@medmail.com.cn
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- ESG206
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG206Drug
Also called ESG206-2
Administered via intravenous (IV) infusion
ESG206Drug
Administered via intravenous (IV) infusion
ESG206Drug
Administered via intravenous (IV) infusion
ESG206Drug
Administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| ESG206 dose level 1 | Experimental | ESG206 will be administered intravenously at dose level 1. Receives: Drug: ESG206 |
| ESG206 dose level 2 | Experimental | ESG206 will be administered intravenously at dose level 2. Receives: Drug: ESG206 |
| ESG206 dose level 3 | Experimental | ESG206 will be administered intravenously at dose level 3. Receives: Drug: ESG206 |
| ESG206 dose level 4 | Experimental | ESG206 will be administered intravenously at dose level 4. Receives: Drug: ESG206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation after the start of study drug through 28 days after the last dose of study drug or the last post-treatment follow-up. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Measured: Up to 24 weeks.
Confirmed response rate
Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of:
Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Secondary outcomes (16)
AUC0-inf
Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity
Measured: up to Week 25
Cmax
Maximum observed plasma concentration
Measured: up to Week 25
Tmax
Time to maximum plasma concentration
Measured: up to Week 25
T1/2
Half-life
Measured: up to Week 25
Response rate at each timepoint
Percentage of participants with a platelet count of at least 50 G/L in the absence of rescue treatment/new ITP treatment.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Complete Response rate at each timepoint
Percentage of participants with a platelet count of at least 100 G/L in the absence of rescue treatment/new ITP treatment.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Best Response rate at each timepoint
Percentage of participants with Response or Complete Response in the absence of rescue treatment/new ITP treatment.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Time to confirmed response
Time from the first administration of ESG206 to the first assessment in the first sequence of two (or more) platelet assessments meeting the criteria of a confirmed response as defined by the primary endpoint.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Time to complete response
Time from the first administration of ESG206 to the first assessment meeting the criteria of a complete response.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Time to treatment failure
Time from the first administration until platelet count below 30 G/L, need for a rescue treatment or start of a new therapy or death.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Duration of response
Time from achievement of response to loss of response
Measured: Between Week 1 Day 1 and Week 25 Day 1
Duration of complete response
Time from achievement of complete response to loss of complete response.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Percentage of participants receiving rescue treatment
Assess the need of rescue treatment by percentage.
Measured: Between Week 1 Day 1 and Week 25 Day 1
Change from baseline in absolute number of CD19+ B cell counts
Post baseline absolute number of CD19+ B cell counts compare with baseline
Measured: Between Week 1 Day 1 and Week 25 Day 1
Change from baseline in absolute number of CD20+ B cell counts
Post baseline absolute number of CD20+ B cell counts compare with baseline
Measured: Between Week 1 Day 1 and Week 25 Day 1
Incidence of anti-drug antibodies in serum (ADA assay) over time
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ESG206
Measured: Between Week 1 Day 1 and Week 25 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start8 May 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Escugen Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming Hou, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853444
- Sponsor's protocol ID
- ESG206-ITP-01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06853444
- Acronym / sponsor ID
- ESG206-ITP-01
- Conditions
- Immune Thrombocytopenia (ITP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai Escugen Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESG206 dose level 1 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 1. |
| ESG206 dose level 2 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 2. |
| ESG206 dose level 3 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 3. |
| ESG206 dose level 4 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESG206Also: ESG206-2Administered via intravenous (IV) infusion | Drug | ESG206 dose level 1 |
| ESG206Administered via intravenous (IV) infusion | Drug | ESG206 dose level 2 |
| ESG206Administered via intravenous (IV) infusion | Drug | ESG206 dose level 3 |
| ESG206Administered via intravenous (IV) infusion | Drug | ESG206 dose level 4 |
Primary outcome
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Time frame: Up to 24 weeks.
Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation after the start of study drug through 28 days after the last dose of study drug or the last post-treatment follow-up. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Confirmed response rate
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.
16 secondary outcomes
AUC0-inf
Time frame: up to Week 25
Cmax
Time frame: up to Week 25
Tmax
Time frame: up to Week 25
T1/2
Time frame: up to Week 25
Response rate at each timepoint
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Complete Response rate at each timepoint
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Best Response rate at each timepoint
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Time to confirmed response
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Time to complete response
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Time to treatment failure
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Duration of response
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Duration of complete response
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Percentage of participants receiving rescue treatment
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Change from baseline in absolute number of CD19+ B cell counts
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Change from baseline in absolute number of CD20+ B cell counts
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Incidence of anti-drug antibodies in serum (ADA assay) over time
Time frame: Between Week 1 Day 1 and Week 25 Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
Related trials for Immune Thrombocytopenia (ITP)
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Hou, PhD contact
Ming Hou, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ESG206 in people with Immune Thrombocytopenia (ITP), run by Shanghai Escugen Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Xing, PhD (86 21 5855 6098, xingxiaoyan@escugen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events (time frame: Up to 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.