SG301-SC Injection Safety Study in Subjects With Primary ITP Patients
ConditionPrimary Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Sumgen Biotech Co., Ltd.
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary objectives are to assess the pharmacokinetic, pharmacodynamic and immunogenicity profiles of SG301 SC Injection in ITP participants.
A total of 60 ITP participants are planned to be enrolled in this study and randomly assigned at a 1:1:1 ratio to the low dose group, high dose group and placebo group, with approximately 20 participants per group. All participants enrolled in this study may receive concomitant background therapies at stable doses for at least 4 weeks prior to the first study drug administration, and is expected to be maintained throughout the study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years, any gender.
Voluntarily signed informed consent and able to comply with study procedures.
Clinically diagnosed with primary immune thrombocytopenia (ITP) per 2019 ASH Guidelines, international consensus statements, or 2025 Chinese Guidelines for Adult ITP Diagnosis and Treatment; disease duration ≥ 3 months.
Experienced treatment failure or relapse after prior first-line therapy (glucocorticoids and/or IVIG).
Disqualifiers
Prior treatment targeting CD38, including but not limited to monoclonal antibodies, bispecific antibodies and antibody-drug conjugates.
Secondary thrombocytopenia or concurrent autoimmune hemolytic anemia.
History of thromboembolism within 12 months prior to randomization, or severe bleeding events (hemoptysis, massive gastrointestinal hemorrhage, intracranial hemorrhage, etc.).
Anticoagulants or antiplatelet agents (e.g., aspirin) administered within 4 weeks before randomization.
Trial design
Design model
Parallel
Treatments tested in this trial
low dose group
DrugSG301 SC weekly for a total of 8 doses, subcutaneous injection
high dose group
DrugSG301 SC weekly for a total of 8 doses , subcutaneous injection
Placebo group
DrugSG301 SC Placebo weekly for a total of 8 doses, subcutaneous injection
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: SG301 SC Injection-low dose groupExperimental treatment 1 intervention
Group B: SG301 SC Injection-high dose groupExperimental treatment 1 intervention
Group C: SG301 SC PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6
Time frame
up to 24 weeks2
ORR
Overall platelet response rate
Time frame
at Week 8 of treatmentSponsors and contacts
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Source ClinicalTrials.gov