About this trial
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).
Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.
Confirmed diagnosis of primary ITP for at least 3 months at screening.
Previous treatment with corticosteroids.
Disqualifiers
Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173
Received immunosuppressants (other than corticosteroids) such as Janus kinase [JAK] inhibitors or Bruton tyrosine kinase [BTK] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the first infusion of SHR-2173 (whichever is longer)
Previous treatment with SHR-2173
Trial design
Single group
Treatments tested in this trial
SHR-2173 Injection
DrugSHR-2173 injection treatment
Treatment groups
Trial outcomes
Primary outcomes
The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
The severity of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
Changes in abnormal indicators in laboratory inspection
Secondary outcomes
Percentage of subjects achieving remission response at week 13 of the treatment period
Percentage of subjects achieving remission response at week 25 of the treatment period
Percentage of participants achieving remission response at any time during the treatment period
Proportion of participants achieving confirmed remission after SHR-2173 injection treatment
Sponsors and contacts
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