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NCT Number: NCT05535933

HMPL-523 (Sovleplenib) 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Warm Antibody Autoimmune Hemolytic Anemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fuyang Hospital Of Anhui Medical University, Fuyang, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Patients with serious psychological or mental disorder;
  • Alcoholic or drug abuser;
  • Female patients who are pregnant and lactating.

Treatment and study plan

HMPL-523(300mg PO QD)

Drug

HMPL-523(300mg PO QD)

Other names: Sovleplenib

Placebo

Drug

Placebo(300mg PO QD)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Phase II: Overall Hb response rate

    Time frame: 8 Weeks

    Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 8

  2. Phase II: Durable Hb response rate

    Time frame: 24 Weeks

    Phase II: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24.

  3. Phase II: Median change in Hb

    Time frame: 24 Weeks

    Phase II: Median change from baseline in Hb at Weeks 8 and 24 of treatment.

  4. Phase II: Effects on reticulocyte count

    Time frame: 24 Weeks

    Phase II: Change from baseline in reticulocyte count at Weeks 8 and 24 of treatment.

  5. Phase II: Effects on lactate dehydrogenase

    Time frame: 24 Weeks

    Phase II: Change from baseline in lactate dehydrogenase(LDH) at Weeks 8 and 24 of treatment.

  6. Phase II: Effects on haptoglobin

    Time frame: 24 Weeks

    Phase II: Change from baseline in haptoglobin at Weeks 8 and 24 of treatment.

  7. Phase II: Effects on total bilirubin(TBIL)

    Time frame: 24 Weeks

    Phase II: Change from baseline in total bilirubin(TBIL) at Weeks 8 and 24 of treatment.

  8. Phase II: Proportion of rescue therapy

    Time frame: 24 Weeks

    Phase II: Proportion of patients who received rescue therapy by Weeks 8 and 24 of treatment.

  9. Phase II: Proportion of patients with dose reduction in baseline anti-wAIHA medications

    Time frame: 24 Weeks

    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.

  10. Phase II: Time to response

    Time frame: 24 Weeks

    Phase II: Time to response

  11. Phase II: Effect of study treatment on patient fatigue

    Time frame: 24 Weeks

    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)

  12. Phase II: Effect of study treatment on quality of life

    Time frame: 24 Weeks

    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).

  13. Phase III(Part A): Overall Hb response rate

    Time frame: 24 Weeks

    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).

  14. Phase III(Part A): Median change in Hb

    Time frame: 24 Weeks

    Phase III(Part A): Median change from baseline in Hb during the 20-week and 24-week double-blind treatment periods.

  15. Phase III(Part A): Effects on reticulocyte count

    Time frame: 24 Weeks

    Phase III(Part A): Change from baseline in reticulocyte count during the 20-week and 24-week double-blind treatment periods.

  16. Phase III(Part A): Effects on lactate dehydrogenase

    Time frame: 24 Weeks

    Phase III(Part A): Change from baseline in lactate dehydrogenase(LDH) during the 20-week and 24-week double-blind treatment periods.

  17. Phase III(Part A): Effects on haptoglobin

    Time frame: 24 Weeks

    Phase III(Part A): Change from baseline in haptoglobin during the 20-week and 24-week double-blind treatment periods.

  18. Phase III(Part A): Effects on total bilirubin(TBIL)

    Time frame: 24 Weeks

    Phase III(Part A): Change from baseline in total bilirubin(TBIL) during the 20-week and 24-week double-blind treatment periods.

  19. Phase III(Part A): Proportion of rescue therapy

    Time frame: 24 Weeks

    Phase III(Part A): Proportion of patients who received protocol-defined rescue therapy during the 20-week and 24-week double-blind treatment periods.

  20. Phase III (Part A): Proportion of patients reducing or discontinuing baseline anti-wAIHA medications

    Time frame: 24 Weeks

    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.

  21. Phase III(Part A): Time to first response

    Time frame: 24 Weeks

    Phase III(Part A): Time to first response

  22. Phase III(Part A): Duration of durable response

    Time frame: 24 Weeks

    Phase III(Part A): Duration of durable response

  23. Phase III(Part A): Cumulative duration of response

    Time frame: 24 Weeks

    Phase III(Part A): Cumulative duration of response

  24. Phase III(Part A): Effect of study treatment on patient fatigue

    Time frame: 24 Weeks

    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).

  25. Phase III(Part A): Effect of study treatment on patients' quality

    Time frame: 24 Weeks

    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.

Other outcomes

  1. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Time frame: 36 Months

    Incidence of treatment-emergent adverse events (TEAEs) assessed according to NCI CTCAE Version 5.0.

  2. Phase II:Efficacy in patients with DAT positivity confirmed by the central laboratory

    Time frame: 24 Weeks

    Phase II: Assessed by overall Hb response rate and durable response rate.

  3. Phase III(Part B): Durable Hb response rate

    Time frame: 30 Months

    Phase III(Part B): Durable Hb response rate: the proportion of patients who achieve a durable response during Part B.

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study 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

Acronym: wAIHA

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 10, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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