New pill could help adults with low platelet disorder

NCT ID NCT05029635

Disease control Sponsor: Hutchmed Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested an oral drug called HMPL-523 (sovleplenib) in 272 adults with chronic immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risks. Participants who had not responded well to prior treatments received either the drug or a placebo daily for 24 weeks. The study measured whether platelet counts could be raised and maintained at safe levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: HMPL-523 (sovleplenib)
What this could lead to: If successful, this could provide a new oral treatment option for adults with chronic ITP who have not responded well to standard therapies.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

272 people

The number who actually took part.

Started

Oct 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for double-blind phase: 1. Voluntary signature of written informed consent form; 2. Male or female aged 18\~75 years; 3. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1; 4. Having been diagnosed as ITP prior to randomization, and duration of disease is more than 6 months; 5. Intolerance or insufficient response, or recurrence after at least one anti-ITP standard drug therapy; 6. Patients must have a history of response to previous ITP therapy; 7. One combined anti-ITP therapy is allowed in this study, however, the following criteria need to be met: 1. The dose of glucocorticoid has been stable for 4 weeks prior to randomization (\<20 mg Prednisone equivalent); 2. The dose of Danazol has been stable for 3 months prior to randomization; 3. The dose of immunosuppressant (only including Azathioprine, Ciclosporin A, Mycophenolate mofetil) has been stable for 3 months prior to randomization. 8. The condition is relatively stable; WHO bleeding scale grade is 0-1; no emergency treatment is expected within 2 weeks as judged by investigators. 9. The laboratory examinations need to meet the following conditions (no treatment for this abnormal variable is given within one week prior to blood collection): 1. 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; 2. Hemoglobin ≥100 g/L, neutrophil count \>1.5×10\^9/L; 3. Total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal (ULN); 4. Serum creatinine concentration ≤1.5×ULN and creatinine clearance ≥50 mL/min; 5. Serum amylase and lipase ≤1.5×ULN; 6. International normalized ratio (INR), activated partial thromboplastin time (APTT) not exceeding 20% of normal range. 10. 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. Exclusion Criteria for double-blind phase: 1. Evidence on the presence of secondary causes of immune thrombocytopenia; 2. Clinically serious hemorrhage requiring immediate adjustment of platelet (e.g., hypermenorrhea with significantly decreased hemoglobin); 3. 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); 4. known history of vital organ transplantation or hematopoietic stem cell / bone marrow transplantation; 5. Has received live vaccine within 8 weeks prior to Day 1 (baseline visit); or plan for immunization with live vaccine during the study; 6. Splenectomy within 12 weeks prior to randomization; 7. Major surgery within 4 weeks prior to the randomization, or plan for major elective surgery during the study; 8. Previous history of malignant tumors (except for the basal cell carcinoma of skin or cervical carcinoma in situ that have been cured); 9. History of important arterial / venous embolic disease; 10. Intracranial hemorrhage within 6 months before screening visit; 11. 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); 12. Hypertension that can not be controlled with drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); 13. Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs; 14. 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; 15. 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); 16. 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; 17. Having received Rituximab within 14 weeks prior to randomization; 18. Having received traditional Chinese medicine within 1 week prior to randomization; 19. 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; 20. 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); 21. 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); 22. Having received spleen tyrosine kinase Syk inhibitor (e.g., Fostamatinib) previously; 23. Known allergy to the active ingredient or excipient of study drug; 24. Presence of serious psychological or mental disorder; 25. Alcoholic or drug abuser; 26. Female patients in pregnancy or breast feeding; 27. Being unsuitable to participate in this study, as considered by investigators. Inclusion Criteria for open label phase: 1. Voluntary signing of the ICF for the sub-study; 2. Performance status score (ECOG score) 0-1; 3. Relatively stable disease, WHO bleeding grade 0-1; 4. 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; 5. 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. Exclusion Criteria for open label phase: 1. History of significant arterial/venous embolic disease; 2. History of serious cardiovascular disease； 3. Hypertension uncontrolled by medications； 4. Known hypersensitivity to the active ingredient or excipients of the study drug; 5. Patients with severe psychological or mental disorders; 6. Alcoholics or drug abusers; 7. Female patients who are pregnant and lactating; 8. Patients who, in the opinion of the investigator, are not suitable for this study.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura primary thrombocytopenia Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immune thrombocytopenia (ITP)

Contacts and locations

Locations

Affiliated Hospital of North China University of Technology

Tangshan, Hebei, China
Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, China
Blood Institute of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, China
Guangdong General Hospital

Guangzhou, Guangdong, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China
Jinan Central Hospital Affilated to Sandong University

Jinan, Shandong, China
Jinshan Hospital Affiliated To Fudan University

Shanghai, Shanghai Municipality, China
Lanzhou University Second Hospital

Lanzhou, Gansu, China
LiaoCheng People's Hospital

Liaocheng, Shandong, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, China
People's Hospital of Peking University

Beijing, Beijing Municipality, China
Qinghai province people's hospital

Xining, Qinghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital

Xi’an, Shanxi, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Southern Hospital of Southern Medical University

Guangzhou, Guangdong, China
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China
The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University

Huai'an, Nanjing Province, China
The First Affiliated Hospital Of GuangXi Medical University

Nanning, Guangxi, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China
The First Affiliated hospital of USTC

Hefei, Anhui, China
The First Affilicated Hospital of Xinjiang Medical University

Ürümqi, The Xinjiang Uygur Autonomous Region, China
The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
The Second People's Hospital Of Shenzhen

Shenzhen, Guangdong, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, China
The second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
The second hospital of Shanxi Medical University

Taiyuan, Shanxi, China
Union Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China
West China Hospital，Sichuan University

Chengdu, Sichuan, China
Xiangya Hospital Central South University

Changsha, Hunan, China
Xiangyang Central Hospital

Xiangyang, Hubei, China
Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, Zejiang Province, China

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