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Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA.
Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
Phase III Study (Part B): To further evaluate the long-term safety and tolerability of HMPL-523 in adult patients with wAIHA.
Phase II Study: An eight-week randomized, placebo-controlled, double-blind phase followed by at least a 16-week open-label HMPL-523 treatment to evaluate the safety and preliminary efficacy of HMPL-523. The primary endpoint was the proportion of patients with overall Hb response by week 24.
Phase III study (Part A):A 24-week randomized, placebo-controlled double-blind phase to evaluate efficacy and safety of HMPL-523. The primary endpoint was the proportion of patients who achieve a durable response during weeks 5 to 24.
Phase III Study (Part B): An open-label Phase evaluating long-term safety and efficacy of HMPL-523 treatment. Eligible patients include those with lack of efficacy during the 20-week Phase III Part A treatment, completion of the Phase II study, or completion of 24-week Phase III Part A treatment with investigators assessment of potential benefit from open-label treatment with HMPL-523.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMPL-523 | Experimental | Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Part A (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks. Part B (Open-label Phase): Eligible subjects will roll-over into the open-label phase and receive treatment with HMPL-523 at the same dose administered after 24-week randomized controlled trial phase (Part A) or in Phase II. Treatment will continue until 24 weeks after the last subject is enrolled in Part B. |
|
| Placebo | Placebo Comparator | Phase II: Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 8 weeks. Phase III: Part A (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-523(300mg PO QD) | Drug | HMPL-523(300mg PO QD) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Overall Hb response rate | Phase II: Overall Hb response rate: The proportion of patients with overall Hb response by Week 24 | 24Weeks |
| Phase III(Part A): Durable Hb response rate | Phase III(Part A):Durable Hb response rate: The proportion of patients who achieve a durable response by Week 24 during Part A | 24Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Overall Hb response rate | Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 8 | 8 Weeks |
| Phase II: Durable Hb response rate | Phase II: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Incidence of treatment-emergent adverse events (TEAEs) assessed according to NCI CTCAE Version 5.0. | 36 Months |
| Phase II:Efficacy in patients with DAT positivity confirmed by the central laboratory |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengkui Zhang, professor | offices director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang Hospital Of Anhui Medical University | Fuyang | Anhui | China | |||
| Fujian Medical University Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39799953 | Derived | Zhao X, Sun J, Zhang Z, Chen M, Gong T, He G, Li Y, Liu H, Li F, Li X, Zhou H, Wang X, Hong M, Lei L, Yin H, Luo X, Li Y, Fan S, Guo X, Shi MM, Su W, Zhang L, Han B, Zhang F. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025 Feb;12(2):e97-e108. doi: 10.1016/S2352-3026(24)00344-2. Epub 2025 Jan 9. |
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The results of this study can be published in core journals or international scientific conferences, and the primary investigators who make significant contributions to the implementation and management of this study and the personnel who makes great contributions to the design, interpretation or analysis of this study (such as the staffs or consultants of the sponsor) can have their authorship attribution. The sponsor promises to provide the manuscript to the investigator for review before publication of any result of the study. Investigators have to obtain the approval of the sponsor before submitting academic articles or abstracts. The study personnel have the right to publish results of this study, however, the requirement of protecting confidential information must be met.
The confidential information is the property of the sponsor only, cannot be disclosed to others without the written approval of the sponsor, and cannot be used for other purposes.
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| Placebo | Drug | Placebo(300mg PO QD) |
|
| 24 Weeks |
| Phase II: Median change in Hb | Phase II: Median change from baseline in Hb at Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Effects on reticulocyte count | Phase II: Change from baseline in reticulocyte count at Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Effects on lactate dehydrogenase | Phase II: Change from baseline in lactate dehydrogenase(LDH) at Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Effects on haptoglobin | Phase II: Change from baseline in haptoglobin at Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Effects on total bilirubin(TBIL) | Phase II: Change from baseline in total bilirubin(TBIL) at Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Proportion of rescue therapy | Phase II: Proportion of patients who received rescue therapy by Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Proportion of patients with dose reduction in baseline anti-wAIHA medications | Phase II: Proportion of patients who had a dose reduction in glucocorticoids or other baseline concomitant anti-wAIHA medications by Weeks 8 and 24 of treatment. | 24 Weeks |
| Phase II: Time to response | Phase II: Time to response | 24 Weeks |
| Phase II: Effect of study treatment on patient fatigue | Phase II: Evaluation of the effect of study treatment on fatigue at Weeks 8 and 24, as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 24 Weeks |
| Phase II: Effect of study treatment on quality of life | Phase II: Evaluation of the effect of study treatment on quality of life at Weeks 8 and 24, as assessed by the 36-Item Short Form Health Survey (SF-36). | 24 Weeks |
| Phase III(Part A): Overall Hb response rate | Phase III(Part A): Proportion of patients who achieved an overall Hb response during the 20-week and 24-week double-blind treatment periods(defined as at least one Hb value ≥100g/L with an increase of at least 20g/L from baseline, not attributable to rescue therapy). | 24 Weeks |
| Phase III(Part A): Median change in Hb | Phase III(Part A): Median change from baseline in Hb during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Effects on reticulocyte count | Phase III(Part A): Change from baseline in reticulocyte count during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Effects on lactate dehydrogenase | Phase III(Part A): Change from baseline in lactate dehydrogenase(LDH) during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Effects on haptoglobin | Phase III(Part A): Change from baseline in haptoglobin during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Effects on total bilirubin(TBIL) | Phase III(Part A): Change from baseline in total bilirubin(TBIL) during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Proportion of rescue therapy | Phase III(Part A): Proportion of patients who received protocol-defined rescue therapy during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III (Part A): Proportion of patients reducing or discontinuing baseline anti-wAIHA medications | Phase III(Part A):The proportion of patients who reduced or discontinued glucocorticoids or other baseline concomitant anti-wAIHA medications during the 20-week and 24-week double-blind treatment periods. | 24 Weeks |
| Phase III(Part A): Time to first response | Phase III(Part A): Time to first response | 24 Weeks |
| Phase III(Part A): Duration of durable response | Phase III(Part A): Duration of durable response | 24 Weeks |
| Phase III(Part A): Cumulative duration of response | Phase III(Part A): Cumulative duration of response | 24 Weeks |
| Phase III(Part A): Effect of study treatment on patient fatigue | Phase III(Part A): Effect of study treatment on patient fatigue during the 20-week and 24-week treatment periods, as assessed by the FACIT-F score (40 items; range, 0-160), including the FACIT-Fatigue subscale (13 items; range, 0-52). | 24 Weeks |
| Phase III(Part A): Effect of study treatment on patients' quality | Phase III(Part A): Effect of study treatment on patients' quality of life during the 20-week and 24-week treatment periods, as assessed by SF-36. | 24 Weeks |
Phase II: Assessed by overall Hb response rate and durable response rate.
| 24 Weeks |
| Phase III(Part B): Durable Hb response rate | Phase III(Part B): Durable Hb response rate: the proportion of patients who achieve a durable response during Part B. | 30 Months |
| Fuzhou |
| Fujian |
| China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | China |
| Nanfang hospital | Guangzhou | Guangdong | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | China |
| Guilin Medical College Affiliated Hospital | Guilin | Guangxi | China |
| Hainan General Hospital | Haikou | Hainan | China |
| Affiliated hospital of Hebei university | Baoding | Hebei | China |
| Affiliated hospital of chengde medical university | Chengde | Hebei | China |
| Harbin First Hospital | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Henan University Of Science and Technology | Luoyang | Henan | China |
| Xinxiang Central Hospital | Xinxiang | Henan | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Xiangyang Center Hospital | Xiangyang | Hubei | China |
| The First People's Hospital of Changde City | Changde | Hunan | China |
| The third xiangya hospital of central south university | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Chenzhou First People's Hospital | Chenzhou | Hunan | China |
| Jiangsu province hospital | Nanjing | Jiangsu | China |
| Affiliated hospital of nantong university | Nantong | Jiangsu | China |
| Jiangxi Provincial people's Hospital | Nanchang | Jiangxi | China |
| The First affiliated hospital of nanchang uiversity | Nanchang | Jiangxi | China |
| Bethune First Hospital Of Jilin University | Changchun | Jilin | China |
| Qinghai provincial people's hospital | Xining | Qinghai Provincial | China |
| Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | China |
| Affiliated Hospital of Binzhou Medical College | Binzhou | Shandong | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | China |
| Jinshan Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Heping Hospital Affiliated To Changzhi Medical College | Changzhi | Shanxi | China |
| The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | China |
| Xinjiang Uygur Autonomous Region People's Hospital | Ürümqi | Xinjiang | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of WMU | Wenzhou | Zhejiang | China |
| Peking Union Medical College Hospital | Beijing | China |
| Hematology Hospital of Chinese Academy of Medical Sciences | Tianjin | China |