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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA Phase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Bethune First Hospital Of Jilin University
RECRUITING
Changchun
Guangdong Provincial People's Hospital
RECRUITING
Lanzhou
The First affiliated hospital of nanchang uiversity
RECRUITING
Nanchang
Hematology Hospital of Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Angela Niu
angelan@hutch-med.com
18801196102
Time Frame
Start Date: 2022-09-30
Estimated Completion Date: 2026-11
Participants
Target number of participants: 110
Treatments
Experimental: HMPL-523
Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment.~Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.
Placebo_comparator: Placebo
Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment.~Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.
Related Therapeutic Areas
Sponsors
Leads: Hutchison Medipharma Limited