Warm Antibody Autoimmune Hemolytic AnemiaPhase 2/3wAIHANCT05535933
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
A Phase 2/3 study testing HMPL-523(300mg PO QD) in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Hutchmed at 39 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Warm Antibody Autoimmune Hemolytic Anemia
- What is being tested?
- HMPL-523(300mg PO QD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 39 sitesChina
- Study dates
- 30 Sep 2022to Nov 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily signed the informed consent form (ICF);
- Males or females aged 18 to 75 years;
- Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;
- Organs in good function.
Who cannot join
- Patients with other types of AIHA other than wAIHA;
- Patients with secondary wAIHA with unstable underlying disease;
- Patients with drug-induced secondary wAIHA;
- Patients with infections requiring systemic treatment;
- Patients previously treated with Syk inhibitors (e.g., fostamatinib);
- Patients with known allergy to the active ingredients or excipients of the study drug;
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- Patients with serious psychological or mental disorder;
- Alcoholic or drug abuser;
- Female patients who are pregnant and lactating.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
China39 sites
Affiliated hospital of Hebei university
Baoding, Hebei
Peking Union Medical College Hospital
Beijing
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong
Bethune First Hospital Of Jilin University
Changchun, Jilin
The First People's Hospital of Changde City
Changde, Hunan
The third xiangya hospital of central south university
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
Heping Hospital Affiliated To Changzhi Medical College
Changzhi, Shanxi
Affiliated hospital of chengde medical university
Chengde, Hebei
Chenzhou First People's Hospital
Chenzhou, Hunan
Fuyang Hospital Of Anhui Medical University
Fuyang, Anhui
Fujian Medical University Union Hospital
Fuzhou, Fujian
Nanfang hospital
Guangzhou, Guangdong
Guilin Medical College Affiliated Hospital
Guilin, Guangxi
Hainan General Hospital
Haikou, Hainan
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Harbin First Hospital
Harbin, Heilongjiang
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Lanzhou University Second Hospital
Lanzhou, Gansu
The First Affiliated Hospital of Henan University Of Science and Technology
Luoyang, Henan
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Jiangxi Provincial people's Hospital
Nanchang, Jiangxi
The First affiliated hospital of nanchang uiversity
Nanchang, Jiangxi
Jiangsu province hospital
Nanjing, Jiangsu
Affiliated hospital of nantong university
Nantong, Jiangsu
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang
The First Affiliated Hospital of WMU
Wenzhou, Zhejiang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Xiangyang Center Hospital
Xiangyang, Hubei
Qinghai provincial people's hospital
Xining, Qinghai Provincial
Xinxiang Central Hospital
Xinxiang, Henan
Yantai Yuhuangding Hospital
Yantai, Shandong
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
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.
Read the detailed description
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.
- Being tested
- HMPL-523(300mg PO QD), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-523(300mg PO QD)Drug
Also called Sovleplenib
HMPL-523(300mg PO QD)
PlaceboDrug
Placebo(300mg PO QD)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HMPL-523(300mg PO QD) |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Overall Hb response rate
Phase II: Overall Hb response rate: The proportion of patients with overall Hb response by Week 24
Measured: 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
Measured: 24Weeks
Secondary outcomes (25)
Phase II: Overall Hb response rate
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 8
Measured: 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.
Measured: 24 Weeks
Phase II: Median change in Hb
Phase II: Median change from baseline in Hb at Weeks 8 and 24 of treatment.
Measured: 24 Weeks
Phase II: Effects on reticulocyte count
Phase II: Change from baseline in reticulocyte count at Weeks 8 and 24 of treatment.
Measured: 24 Weeks
Phase II: Effects on lactate dehydrogenase
Phase II: Change from baseline in lactate dehydrogenase(LDH) at Weeks 8 and 24 of treatment.
Measured: 24 Weeks
Phase II: Effects on haptoglobin
Phase II: Change from baseline in haptoglobin at Weeks 8 and 24 of treatment.
Measured: 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.
Measured: 24 Weeks
Phase II: Proportion of rescue therapy
Phase II: Proportion of patients who received rescue therapy by Weeks 8 and 24 of treatment.
Measured: 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.
Measured: 24 Weeks
Phase II: Time to response
Phase II: Time to response
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Weeks
Phase III(Part A): Time to first response
Phase III(Part A): Time to first response
Measured: 24 Weeks
Phase III(Part A): Duration of durable response
Phase III(Part A): Duration of durable response
Measured: 24 Weeks
Phase III(Part A): Cumulative duration of response
Phase III(Part A): Cumulative duration of response
Measured: 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).
Measured: 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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start30 Sep 2022
- Primary completion25 Nov 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Warm Antibody Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengkui Zhang, professor, Principal investigator, offices director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535933
- Sponsor's protocol ID
- 2022-523-00CH1
- Acronym
- wAIHA
- Status last verified
- May 2026
- First submitted
- 31 Aug 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39799953
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT05535933
- Acronym / sponsor ID
- wAIHA / 2022-523-00CH1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMPL-523 | Experimental | Drug: HMPL-523(300mg PO QD)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 | Drug: PlaceboPhase 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily signed the informed consent form (ICF);
- Males or females aged 18 to 75 years;
- Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;
- Organs in good function.
Key exclusion criteria (9 listed)
- Patients with other types of AIHA other than wAIHA;
- Patients with secondary wAIHA with unstable underlying disease;
- Patients with drug-induced secondary wAIHA;
- Patients with infections requiring systemic treatment;
- Patients previously treated with Syk inhibitors (e.g., fostamatinib);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-523(300mg PO QD)Also: SovleplenibHMPL-523(300mg PO QD) | Drug | HMPL-523 |
| PlaceboPlacebo(300mg PO QD) | Drug | Placebo |
Primary outcome
Phase II: Overall Hb response rate
Time frame: 24Weeks
Phase II: Overall Hb response rate: The proportion of patients with overall Hb response by Week 24
Phase III(Part A): Durable Hb response rate
Time frame: 24Weeks
Phase III(Part A):Durable Hb response rate: The proportion of patients who achieve a durable response by Week 24 during Part A
25 secondary outcomes
Phase II: Overall Hb response rate
Time frame: 8 Weeks
Phase II: Durable Hb response rate
Time frame: 24 Weeks
Phase II: Median change in Hb
Time frame: 24 Weeks
Phase II: Effects on reticulocyte count
Time frame: 24 Weeks
Phase II: Effects on lactate dehydrogenase
Time frame: 24 Weeks
Phase II: Effects on haptoglobin
Time frame: 24 Weeks
Phase II: Effects on total bilirubin(TBIL)
Time frame: 24 Weeks
Phase II: Proportion of rescue therapy
Time frame: 24 Weeks
Phase II: Proportion of patients with dose reduction in baseline anti-wAIHA medications
Time frame: 24 Weeks
Phase II: Time to response
Time frame: 24 Weeks
Phase II: Effect of study treatment on patient fatigue
Time frame: 24 Weeks
Phase II: Effect of study treatment on quality of life
Time frame: 24 Weeks
Phase III(Part A): Overall Hb response rate
Time frame: 24 Weeks
Phase III(Part A): Median change in Hb
Time frame: 24 Weeks
Phase III(Part A): Effects on reticulocyte count
Time frame: 24 Weeks
Phase III(Part A): Effects on lactate dehydrogenase
Time frame: 24 Weeks
Phase III(Part A): Effects on haptoglobin
Time frame: 24 Weeks
Phase III(Part A): Effects on total bilirubin(TBIL)
Time frame: 24 Weeks
Phase III(Part A): Proportion of rescue therapy
Time frame: 24 Weeks
Phase III (Part A): Proportion of patients reducing or discontinuing baseline anti-wAIHA medications
Time frame: 24 Weeks
Phase III(Part A): Time to first response
Time frame: 24 Weeks
Phase III(Part A): Duration of durable response
Time frame: 24 Weeks
Phase III(Part A): Cumulative duration of response
Time frame: 24 Weeks
Phase III(Part A): Effect of study treatment on patient fatigue
Time frame: 24 Weeks
Phase III(Part A): Effect of study treatment on patients' quality
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 39799953Zhao 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengkui Zhang, professor principal investigator
offices director
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HMPL-523(300mg PO QD) in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Hutchmed at 39 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 18 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 39 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
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?
Phase II: Overall Hb response rate (time frame: 24Weeks). The study lists 2 primary outcomes in all. 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 NCT05535933, 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 18 May 2026.