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Promising ITP drug trial pulled before it even started

NCT ID NCT06291415

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study was designed to test the safety and tolerability of a new drug called HMPL-523 (sovleplenib) in adults with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding problems. The trial was withdrawn before enrolling any participants, so no results are available. It would have included adults who had not responded to at least one prior ITP treatment.

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), a Syk inhibitor

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Started

Apr 2024

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 years and older

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: Subjects may be enrolled in this study only if they satisfy all the following criteria: 1. Adult male or female subjects ≥18 years of age 2. Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment 3. Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy) 4. Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy) 5. Adequate hematologic, hepatic and renal function Exclusion Criteria: Subjects are not eligible for enrollment into this study if any one of the following criteria are met: 1. Evidence of the presence of secondary causes of ITP 2. Clinically serious hemorrhage requiring immediate adjustment of platelets 3. Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy 4. Splenectomy within 12 weeks prior to enrollment 5. Presence of active malignancy unless deemed cured by adequate treatment. 6. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms 7. Uncontrolled hypertension 8. Being unsuitable to participate in this study as considered by investigators

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Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune thrombocytopenic purpura blood coagulation disease blood platelet disease hematologic disorder Hemorrhage hemorrhagic disease immune system disorder Pathologic Processes primary thrombocytopenia purpura Purpura, Thrombocytopenic, Idiopathic Skin Manifestations thrombocytopenia thrombocytopenia due to immune destruction thrombocytopenic purpura thrombotic microangiopathy

As listed by the trial registrant

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

Autoimmune diseases Blood coagulation disorder Blood platelet disorder Hematologic diseases Hemorrhage Hemorrhagic disorders Immune system diseases Immune thrombocytopenia ITP - immune thrombocytopenia Pathologic processes Primary immune thrombocytopenia Purpura Purpura, thrombocytopenic Purpura, thrombocytopenic, idiopathic Skin manifestations Thrombocytopenia Thrombotic microangiopathies

Contacts and locations

Locations

  • Canberra Hospital

    Canberra, Australia

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817, United States

  • Charite university

    Berlin, 10117, Germany

  • Childrens Hospital of California

    Irvine, California, 92868, United States

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • East Carolina University, Brody School of Medicine

    Greenville, North Carolina, 27834, United States

  • Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Georgetown University Medical Center - Georgetown Lombardi Comprehensive Cancer Center

    Georgetown, Delaware, 20007, United States

  • Hospital Gregorio Maranon Madrid

    Madrid, 28007, Spain

  • Hospital Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Morales Meseguer

    Murcia, 30008, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital del Mar Barcelona

    Barcelona, 08003, Spain

  • Marien Hospital Dusseldorf

    Düsseldorf, 40479, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146, United States

  • Oslo University Hospital

    Oslo, Norway

  • Peninsula Private Hospital

    Frankston, Victoria, Australia

  • Royal Adelaide Hospital

    Adelaide, Australia

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL)

    Grålum, 1714, Norway

  • Taussig Cancer Institute

    Cleveland, Ohio, 44106, United States

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78240, United States

  • The Perth Blood Institute (PBI) Hollywood Specialist Centre

    West Perth, Western Australia, Australia

  • UMG Gottingen Hämatologie

    Göttingen, Germany

  • University Hospital of Schleswig-Holstein, Department of Haematology and Oncology

    Lübeck, Germany

  • University de Burgos

    Burgos, 09001, Spain

  • University of Washington (UW) Medical Center

    Seattle, Washington, 98195, United States

More trials for these conditions

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