Phase III Study on HMPL-523 for Treatment of ITP

NCT05029635 | Completed Phase 3 DMC

• 1 other identifier: 2020-523-00CH1
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 37

Brief 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).

Conditions

Primary Immune Thrombocytopenia (ITP)

Keywords

HMPL-523, sovleplenib, ITP, ESLIM-01

Outcome Measures

Primary Outcomes (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

  treatment period Week14-Week24

Secondary Outcomes (5)

• the overall response rate in the primary study

  treatment period Week1-Week24 in the primary study

• Incidence of treatment emergent adverse events

  treatment period Week1-Week24 in the primary study

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

  treatment period Week1-Week24 in the primary study

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

  treatment period Week1-Week24 in the primary study

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

  treatment period Week1-Week24 in the primary study

Study Arms (2)

Drug: HMPL-523

ACTIVE COMPARATOR

Primacy 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.

Drug: HMPL-523

Drug: placebo

PLACEBO COMPARATOR

Primacy study (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks.

Drug: Placebo

Interventions

HMPL-523 DRUG

HMPL-523(300mg PO QD)

Also known as: Sovleplenib

Drug: HMPL-523

Placebo DRUG

Placebo(300mg PO QD)

Drug: placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (37)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated hospital of USTC

Hefei, Anhui, China

Location

Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

People's Hospital of Peking University

Beijing, Beijing Municipality, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

Southern Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The Second People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital Of GuangXi Medical University

Nanning, Guangxi, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Affiliated Hospital of North China University of Technology

Tangshan, Hebei, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

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

Wuhan, Hubei, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

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

Huai'an, Nanjing Province, China

Location

Qinghai province people's hospital

Xining, Qinghai, China

Location

Jinan Central Hospital Affilated to Sandong University

Jinan, Shandong, China

Location

LiaoCheng People's Hospital

Liaocheng, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Jinshan Hospital Affiliated To Fudan University

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Location

The second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Provincial People's Hospital

Xi’an, Shanxi, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

The First Affilicated Hospital of Xinjiang Medical University

Ürümqi, The Xinjiang Uygur Autonomous Region, China

Location

Blood Institute of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

The second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, Zejiang Province, China

Location

Related Publications (1)

• 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.

  PMID: 38885672 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Renchi Yang, professor

  offices director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 31, 2021
• Study Start: October 27, 2021
• Primary Completion: May 16, 2025
• Study Completion: September 18, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (37)