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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05029635
Other study ID # 2020-523-00CH1
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 27, 2021
Est. completion date December 30, 2023

Study information

Verified date February 2023
Source Hutchmed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Description:

This is a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with primary immune thrombocytopenia to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 188
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 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: 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.

Study Design


Related Conditions & MeSH terms

  • Primary Immune Thrombocytopenia (ITP)
  • Purpura, Thrombocytopenic, Idiopathic
  • Thrombocytopenia

Intervention

Drug:
HMPL-523
HMPL-523 will be oral administrated once daily for 24 weeks
Placebo
HMPL-523 matching placebo will be oral administrated once daily for 24 weeks .

Locations

Country Name City State
China Beijing Chaoyang Hospital of Capital Medical University Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China People's Hospital of Peking University Beijing Beijing
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi
China West China Hospital,Sichuan University Chengdu Sichuan
China Fujian Medical University Union Hospital Fuzhou Fujian
China Guangdong General Hospital Guangzhou Guangdong
China Southern Hospital of Southern Medical University Guangzhou Guangdong
China Zhejiang Provincial Hospital of Chinese Medicine Hangzhou Zejiang Province
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui
China The First Affiliated hospital of USTC Hefei Anhui
China The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University Huai'an Nanjing Province
China Jinan Central Hospital Affilated to Sandong University Jinan Shandong
China The second Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Lanzhou University Second Hospital Lanzhou Gansu
China LiaoCheng People's Hospital Liaocheng Shandong
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China The First Affiliated Hospital Of GuangXi Medical University Nanning GuangXi Province
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Jinshan Hospital Affiliated To Fudan University Shanghai Shanghai
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Shengjing Hospital of China Medical University Shenyang Liaoning
China The Second People's Hospital Of Shenzhen Shenzhen Guangdong
China The First Hospital of Hebei Medical University Shijiazhuang Hebei
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China The second hospital of Shanxi Medical University Taiyuan Shanxi
China Affiliated Hospital of North China University of Technology Tangshan Hebei
China Blood Institute of the Chinese Academy of Medical Sciences Tianjin Tianjin
China The First Affilicated Hospital of Xinjiang Medical University Ürümqi The Xinjiang Uygur Autonomous Region
China Union Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Shanxi Provincial People's Hospital Xi'an Shanxi
China Xiangyang Central Hospital Xiangyang Hubei
China Qinghai province people's hospital Xining Qinghai
China First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 treatment period Week14-Week24
Secondary 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 treatment period Week1-Week24 in the primary study
Secondary Incidence of treatment emergent adverse events Adverse events classified according to NCI CTCAE version 5.0 treatment period Week1-Week24 in the primary study
Secondary 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. treatment period Week1-Week24 in the primary study
Secondary 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. treatment period Week1-Week24 in the primary study
Secondary 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. treatment period Week1-Week24 in the primary study
See also
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Recruiting NCT05718856 - TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP) Phase 4
Recruiting NCT05885555 - A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies Phase 2
Recruiting NCT04518475 - Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults Phase 4