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Primary Immune Thrombocytopenia (ITP)Phase 3NCT05029635

Phase III Study on HMPL-523 for Treatment of ITP

A Phase 3 study testing HMPL-523 in people with Primary Immune Thrombocytopenia (ITP), run by Hutchmed at 37 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Immune Thrombocytopenia (ITP)
What is being tested?
HMPL-523
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
37 sitesChina
Study dates
27 Oct 2021to 18 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signature of written informed consent form;
  • Male or female aged 18~75 years;
  • Performance Status score [Eastern Cooperative Oncology Group (ECOG) score] 0~1;
  • Having been diagnosed as ITP prior to randomization, and duration of disease is more than 6 months;
  • Intolerance or insufficient response, or recurrence after at least one anti-ITP standard drug therapy;
  • Patients must have a history of response to previous ITP therapy;
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  • One combined anti-ITP therapy is allowed in this study, however, the following criteria need to be met:
  • The dose of glucocorticoid has been stable for 4 weeks prior to randomization (<20 mg Prednisone equivalent);
  • The dose of Danazol has been stable for 3 months prior to randomization;
  • The dose of immunosuppressant (only including Azathioprine, Ciclosporin A, Mycophenolate mofetil) has been stable for 3 months prior to randomization.
  • The condition is relatively stable; WHO bleeding scale grade is 0-1; no emergency treatment is expected within 2 weeks as judged by investigators.
  • The laboratory examinations need to meet the following conditions (no treatment for this abnormal variable is given within one week prior to blood collection):
  • Average platelet count <30×10^9 /L (and none > 35×10^9 /L unless as a result of rescue therapy) from at least 3 qualifying counts;
  • Hemoglobin ≥100 g/L, neutrophil count >1.5×10^9/L;
  • Total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal (ULN);
  • Serum creatinine concentration ≤1.5×ULN and creatinine clearance ≥50 mL/min;
  • Serum amylase and lipase ≤1.5×ULN;
  • International normalized ratio (INR), activated partial thromboplastin time (APTT) not exceeding 20% of normal range.
  • Male or female patients of childbearing potential must agree to use effective contraceptive methods during the study and within 90 days after last dose of study drug, e.g., double barrier contraceptive method, condom, oral or injectable contraceptives, intrauterine device, etc. Postmenopausal women (>50 years old and no menses for >1 year) and surgically sterilized women are not subject to this condition.
  • Voluntary signing of the ICF for the sub-study;
  • Performance status score (ECOG score) 0-1;
  • Relatively stable disease, WHO bleeding grade 0-1;
  • Female patients of childbearing potential must agree to use highly effective treatment of contraception from screening until 30 days after discontinuation of study treatment of;
  • Male patients with fertile female partners must consent to use barrier contraception during the study period and for 30 days after the termination of study treatment.

Who cannot join

  • Evidence on the presence of secondary causes of immune thrombocytopenia;
  • Clinically serious hemorrhage requiring immediate adjustment of platelet (e.g., hypermenorrhea with significantly decreased hemoglobin);
  • Clinically symptomatic gastrointestinal hemorrhage within 6 months prior to screening visit (e.g., haematemesis, tarry stool, however, the positive occult blood test without any sign or symptom of gastrointestinal hemorrhage will not be considered as "clinically symptomatic", or hemorrhoids hemorrhage is one exception);
  • known history of vital organ transplantation or hematopoietic stem cell / bone marrow transplantation;
  • Has received live vaccine within 8 weeks prior to Day 1 (baseline visit); or plan for immunization with live vaccine during the study;
  • Splenectomy within 12 weeks prior to randomization;
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  • Major surgery within 4 weeks prior to the randomization, or plan for major elective surgery during the study;
  • Previous history of malignant tumors (except for the basal cell carcinoma of skin or cervical carcinoma in situ that have been cured);
  • History of important arterial / venous embolic disease;
  • Intracranial hemorrhage within 6 months before screening visit;
  • History of serious cardiovascular disease (e.g., grade III/IV congestive heart failure, arrhythmia or angina pectoris requiring drug therapy, unstable angina pectoris, intracoronary stent implantation, angioplasty or coronary artery bypass grafting, or QTc ≥450 ms);
  • Hypertension that can not be controlled with drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
  • Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs;
  • Human immunodeficiency virus (HIV) infection, or hepatitis B (in case of positive HBsAg or HBcAb, positive HBV DNA needs to be determined), or hepatitis C (positive HCV RNA), or liver cirrhosis;
  • Significant active infection that is not controlled clinically (e.g., sepsis, pneumonia or abscess), or serious infection within 6 weeks prior to randomization (leading to hospitalization or requiring treatment with antibiotic injections);
  • Has received rescue therapy for ITP within 2 weeks prior to randomization; Has received the treatment for the objective of increasing platelet within 4 weeks prior to randomization (including but not limited to glucocorticoid, thrombopoietin, thrombopoietin receptor agonist, Cyclosporine A, Mycophenolate mofetil, etc.), except those meeting the inclusion criterion 7;
  • Having received Rituximab within 14 weeks prior to randomization;
  • Having received traditional Chinese medicine within 1 week prior to randomization;
  • Requiring long-term/continuous use of the drugs that may affect platelet function [including but not limited to aspirin, Clopidogrel, ticagrelor, NSAIDs, etc.], or anticoagulants;
  • Intake of potent CYP3A inhibitor or inducer, as well as sensitive or narrow therapeutic window substrates of CYP3A, CYP1A2 or CYP2B6 two weeks (three weeks for Hypericum perforatum) or 5 half-lives prior to randomization (whichever is longer);
  • Having participated in the clinical study for drugs or invasive medical device 4 weeks prior to randomization (or within 5 half-lives of the study drug prior to randomization, whichever is longer);
  • Having received spleen tyrosine kinase Syk inhibitor (e.g., Fostamatinib) previously;
  • Known allergy to the active ingredient or excipient of study drug;
  • Presence of serious psychological or mental disorder;
  • Alcoholic or drug abuser;
  • Female patients in pregnancy or breast feeding;
  • Being unsuitable to participate in this study, as considered by investigators.
  • History of significant arterial/venous embolic disease;
  • History of serious cardiovascular disease；
  • Hypertension uncontrolled by medications；
  • Known hypersensitivity to the active ingredient or excipients of the study drug;
  • Patients with severe psychological or mental disorders;
  • Alcoholics or drug abusers;
  • Female patients who are pregnant and lactating;
  • Patients who, in the opinion of the investigator, are not suitable for this study.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • People's Hospital of Peking University

    Beijing, Beijing Municipality

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Southern Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zejiang Province

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The First Affiliated hospital of USTC

    Hefei, Anhui

  • The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University

    Huai'an, Nanjing Province

  • Jinan Central Hospital Affilated to Sandong University

    Jinan, Shandong

  • The second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • LiaoCheng People's Hospital

    Liaocheng, Shandong

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The First Affiliated Hospital Of GuangXi Medical University

    Nanning, Guangxi

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Jinshan Hospital Affiliated To Fudan University

    Shanghai, Shanghai Municipality

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The Second People's Hospital Of Shenzhen

    Shenzhen, Guangdong

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • The second hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Affiliated Hospital of North China University of Technology

    Tangshan, Hebei

  • Blood Institute of the Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • The First Affilicated Hospital of Xinjiang Medical University

    Ürümqi, The Xinjiang Uygur Autonomous Region

  • Union Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Shanxi Provincial People's Hospital

    Xi’an, Shanxi

  • Xiangyang Central Hospital

    Xiangyang, Hubei

  • Qinghai province people's hospital

    Xining, Qinghai

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-523 in Treatment of Primary Immune Thrombocytopenia (ITP) in Adults (ESLIM-01 Study)

The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).

Read the detailed description

This study consists of a double-blind phase (primary study) followed by an open-label phase (sub-study). The double-blind phase(n=188) is a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with primary ITP to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic ITP. The sub-study provides open-label HMPL-523 treatment to assess long-term safety and efficacy. The open-label phase have Cohort1 and Cohort 2. Cohort 1 enrolled patients from primary study who have received double-blind study treatment for 12 weeks with sustained platelet count <50×10⁹/L or have received double-blind study treatment for 24 weeks. Cohort 2 enrolled primary ITP patients(n=84) with disease duration >3 months.

Being tested
HMPL-523, Placebo
Keywords
HMPL-523, sovleplenib, ITP, ESLIM-01
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.

  • HMPL-523Drug

    Also called Sovleplenib

    HMPL-523(300mg PO QD)

  • PlaceboDrug

    Placebo(300mg PO QD)

Study groups in NCT05029635
Study groupRoleWhat they receive
Drug: HMPL-523Active comparatorPrimacy study (Randomized, Double-Blind Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 24 weeks. Sub study (Open-label Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 76 weeks after the enrollment of the last patient enrolled in open-label phase.
Receives: Drug: HMPL-523
Drug: placeboPlacebo comparatorPrimacy study (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the durable response rate in the primary study

    Platelet count ≥50×10^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study

    Measured: treatment period Week14-Week24

Secondary outcomes (5)

  1. the overall response rate in the primary study

    At least one platelet count ≥50×10^9 /L (except that induced by the rescue therapy) in the 24-week double-blind treatment period

    Measured: treatment period Week1-Week24 in the primary study

  2. Incidence of treatment emergent adverse events

    Adverse events classified according to NCI CTCAE version 5.0

    Measured: treatment period Week1-Week24 in the primary study

  3. Plasma concentration at steady state 2 hours post dose (C2h,ss)

    Plasma concentration of HMPL-523 and its main metabolites at steady state 2 hours post dose (C2h,ss) will be determined.

    Measured: treatment period Week1-Week24 in the primary study

  4. Plasma concentration at steady state 2 hours post dose (C4h,ss)

    Plasma concentration of HMPL-523 and its main metabolites at steady state 4 hours post dose (C4h,ss) will be determined.

    Measured: treatment period Week1-Week24 in the primary study

  5. Plasma concentration at steady-state trough concentration (Cmin,ss)

    Plasma concentration of HMPL-523 and its main metabolites at steady-state trough concentration (Cmin,ss) will be determined.

    Measured: treatment period Week1-Week24 in the primary study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start27 Oct 2021
  3. Primary completion16 May 2025
  4. Study completion18 Sep 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029635
Sponsor's protocol ID
2020-523-00CH1
Status last verified
Apr 2026
First submitted
8 Aug 2021
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu Y, Liu X, Zhou H, Wang S, Huang R, Wang Y, Du X, Sun J, Zhou Z, Yan Z, Chen W, Wang W, Liu Q, Zeng Q, Gong Y, Yin J, Shen X, Ye B, Chen Y, Xu Y, Sun H, Cheng Y, Liu Z, Wang C, Yuan G, Zhang X, Li X, Cheng P, Guo X, Jiang Z, Yang F, Yang L, Luo C, Xiao T, Fu S, Yin H, Guo X, Xu Q, Fan S, Shi MM, Su W, Mei H, Yang R. Efficacy and safety of sovleplenib (HMPL-523) in adult patients with chronic primary immune thrombocytopenia in China (ESLIM-01): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Haematol. 2024 Aug;11(8):e567-e579. doi: 10.1016/S2352-3026(24)00139-X. Epub 2024 Jun 14.

    PubMed 38885672

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HMPL-523 in people with Primary Immune Thrombocytopenia (ITP), run by Hutchmed at 37 sites 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 24 inclusion and 35 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the durable response rate in the primary study (time frame: treatment period Week14-Week24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05029635, which also lists 1 linked publication.

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 4 May 2026.

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