Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for warm AIHA: drug trial targets blood cell destruction

NCT ID NCT05535933

Disease control Sponsor: Hutchmed Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests a drug called HMPL-523 (Sovleplenib) in people with warm antibody autoimmune hemolytic anemia, a condition where the immune system attacks red blood cells. About 111 adults will receive either the drug or a placebo to see if it improves hemoglobin levels and controls the disease safely. The trial combines early safety checks with later confirmation of effectiveness.

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 offer a new treatment option to control warm AIHA and reduce the need for steroids or other therapies.
What could go wrong
This is an early-to-mid stage trial with only 111 participants. The drug may not work better than placebo, and side effects are still being studied.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

111 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

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: 1. Voluntarily signed the informed consent form (ICF); 2. Males or females aged 18 to 75 years; 3. Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable; 4. Organs in good function. Exclusion Criteria: 1. Patients with other types of AIHA other than wAIHA; 2. Patients with secondary wAIHA with unstable underlying disease; 3. Patients with drug-induced secondary wAIHA; 4. Patients with infections requiring systemic treatment; 5. Patients previously treated with Syk inhibitors (e.g., fostamatinib); 6. Patients with known allergy to the active ingredients or excipients of the study drug; 7. Patients with serious psychological or mental disorder; 8. Alcoholic or drug abuser; 9. Female patients who are pregnant and lactating.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Warm antibody autoimmune hemolytic anemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type

As listed by the trial registrant

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

Warm antibody autoimmune hemolytic anemia

Contacts and locations

Locations

  • Affiliated Hospital of Binzhou Medical College

    Binzhou, Shandong, China

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, China

  • Affiliated hospital of Hebei university

    Baoding, Hebei, China

  • Affiliated hospital of chengde medical university

    Chengde, Hebei, China

  • Affiliated hospital of nantong university

    Nantong, Jiangsu, China

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin, China

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Fuyang Hospital Of Anhui Medical University

    Fuyang, Anhui, China

  • Guilin Medical College Affiliated Hospital

    Guilin, Guangxi, China

  • Hainan General Hospital

    Haikou, Hainan, China

  • Harbin First Hospital

    Harbin, Heilongjiang, China

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Heping Hospital Affiliated To Changzhi Medical College

    Changzhi, Shanxi, China

  • Jiangsu province hospital

    Nanjing, Jiangsu, China

  • Jiangxi Provincial people's Hospital

    Nanchang, Jiangxi, China

  • Jinshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, China

  • Nanfang hospital

    Guangzhou, Guangdong, China

  • Peking Union Medical College Hospital

    Beijing, China

  • Qinghai provincial people's hospital

    Xining, Qinghai Provincial, China

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, China

  • The First Affiliated Hospital of Henan University Of Science and Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of WMU

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First People's Hospital of Changde City

    Changde, Hunan, China

  • The First affiliated hospital of nanchang uiversity

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The third xiangya hospital of central south university

    Changsha, Hunan, China

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

    Wuhan, Hubei, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xiangyang Center Hospital

    Xiangyang, Hubei, China

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, China

  • Xinxiang Central Hospital

    Xinxiang, Henan, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.