NCT05029635
Active, not recruiting
Phase 3
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-523 in Treatment of Primary Immune Thrombocytopenia (ITP) in Adults(ESLIM-01 Study)
Hutchison Medipharma Limited37 sites in 1 country272 target enrollmentStarted: October 27, 2021Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Hutchison Medipharma Limited
- Enrollment
- 272
- Locations
- 37
- Primary Endpoint
- the durable response rate in the primary study
Overview
Brief 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).
Detailed Description
This is a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with primary immune thrombocytopenia to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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);
- •The dose of Danazol has been stable for 3 months prior to randomization;
- •The dose of immunosuppressant (only including Azathioprine, Ciclosporin A, Mycophenolate mofetil) has been stable for 3 months prior to randomization.
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);
- •History of important arterial / venous embolic disease;
- •Intracranial hemorrhage within 6 months before screening visit;
Arms & Interventions
treatment arm
Active Comparator
Eligible subjects will be treated with planned dose of 300 mg HMPL-523 once daily for 24 weeks
Intervention: HMPL-523 (Drug)
placebo arm
Placebo Comparator
Drug: Placebo HMPL-523 matching placebo will be oral administrated once daily for 24 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
the durable response rate in the primary study
Time Frame: treatment period Week14-Week24
Platelet count ≥50×10\^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study
Secondary Outcomes
- Incidence of treatment emergent adverse events(treatment period Week1-Week24 in the primary study)
- the overall response rate in the primary study(treatment period Week1-Week24 in the primary study)
- Plasma concentration at steady state 2 hours post dose (C2h,ss)(treatment period Week1-Week24 in the primary study)
- Plasma concentration at steady-state trough concentration (Cmin,ss)(treatment period Week1-Week24 in the primary study)
- Plasma concentration at steady state 2 hours post dose (C4h,ss)(treatment period Week1-Week24 in the primary study)
Investigators
Study Sites (37)
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