CompletedPhase 3

Phase III Study on HMPL-523 for Treatment of ITP

China272 participantsStarted 2021-10-27

Plain-language summary

The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntary signature of written informed consent form;
✓. Male or female aged 18\~75 years;
✓. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1;
✓. Having been diagnosed as ITP prior to randomization, and duration of disease is more than 6 months;
✓. Intolerance or insufficient response, or recurrence after at least one anti-ITP standard drug therapy;
✓. Patients must have a history of response to previous ITP therapy;
✓. One combined anti-ITP therapy is allowed in this study, however, the following criteria need to be met:
✓. The dose of glucocorticoid has been stable for 4 weeks prior to randomization (\<20 mg Prednisone equivalent);

Exclusion criteria

✕. Evidence on the presence of secondary causes of immune thrombocytopenia;
✕. Clinically serious hemorrhage requiring immediate adjustment of platelet (e.g., hypermenorrhea with significantly decreased hemoglobin);
✕. Clinically symptomatic gastrointestinal hemorrhage within 6 months prior to screening visit (e.g., haematemesis, tarry stool, however, the positive occult blood test without any sign or symptom of gastrointestinal hemorrhage will not be considered as "clinically symptomatic", or hemorrhoids hemorrhage is one exception);
✕. known history of vital organ transplantation or hematopoietic stem cell / bone marrow transplantation;
✕. Has received live vaccine within 8 weeks prior to Day 1 (baseline visit); or plan for immunization with live vaccine during the study;
✕. Splenectomy within 12 weeks prior to randomization;
✕. Major surgery within 4 weeks prior to the randomization, or plan for major elective surgery during the study;
✕. Previous history of malignant tumors (except for the basal cell carcinoma of skin or cervical carcinoma in situ that have been cured);

What they're measuring

the durable response rate in the primary study

Timeframe: treatment period Week14-Week24

Trial details

NCT IDNCT05029635

SponsorHutchmed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-16

View on ClinicalTrials.gov More Primary Immune Thrombocytopenia (ITP) trials