What is SG301 SC Injection studying for primary immune thrombocytopenia?

SG301 SC Injection is being studied to evaluate its safety and effectiveness in adults with primary immune thrombocytopenia. Researchers aim to understand how well the drug works and its immune effects compared to placebo. The study is sponsored by Hangzhou Sumgen Biotech Co., Ltd.

Who may be eligible for this primary immune thrombocytopenia clinical trial?

Adults aged 18 to 75 years diagnosed with primary immune thrombocytopenia for at least 3 months may be eligible. Participants should have experienced relapse or treatment failure after first-line therapies and be on stable maintenance treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this primary immune thrombocytopenia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID07710248

A Randomized, Double-Blind Study Testing Safety and Effectiveness of SG301 SC Injection in Adults with Primary Immune Thrombocytopenia

Led by Hangzhou Sumgen Biotech Co., Ltd. · Updated on 2026-07-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SG301 SC Injection in adults with primary immune thrombocytopenia ITP, a condition characterized by low platelet counts. This Phase II, randomized, double-blind, placebo-controlled study aims to compare low and high doses of SG301 SC Injection against placebo. The study also assesses how the drug behaves in the body and its immune response effects. Participants are randomly assigned to one of three groups low dose SG301 SC Injection, high dose SG301 SC Injection, or placebo, each receiving weekly subcutaneous injections for a total of 8 doses. Background therapies for ITP may be continued at stable doses throughout the study period. The study includes approximately 60 participants, with about 20 in each group. During the trial, participants will undergo safety monitoring for adverse events and evaluation of platelet response up to 24 weeks. Researchers will collect clinical and laboratory data to understand the drugs effects and immune activity. Participants will be assessed regularly to measure treatment outcomes and overall health status throughout the study duration.

CONDITIONS

Brief Title

SG301-SC Injection Safety Study in Subjects With Primary ITP Patients

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18-75 years, any gender
Signed informed consent and able to comply with study procedures
Diagnosed with primary immune thrombocytopenia (ITP) per guidelines, with disease duration of at least 3 months
Experienced treatment failure or relapse after first-line therapy (glucocorticoids and/or IVIG)
At least two platelet assessments at least 3 days apart with mean platelet count below 30×10⁹/L and no single value above 35×10⁹/L before first dosing
ECOG performance status between 0 and 2
On stable-dose maintenance therapy for at least 4 weeks before first dose, expected to remain stable throughout the trial
Screening lab tests meeting liver, renal function, and blood count criteria
Participants or partners with childbearing potential using effective contraception during study and for 6 months after last dose

You will not qualify if you...

Prior treatment targeting CD38 including monoclonal antibodies, bispecific antibodies, or antibody-drug conjugates
Secondary thrombocytopenia or concurrent autoimmune hemolytic anemia
History of thromboembolism within 12 months or severe bleeding events
Use of anticoagulants or antiplatelet agents within 4 weeks before randomization
Emergency ITP therapies within 4 weeks before randomization
Use of certain oral immunosuppressants or anti-CD20 monoclonal antibodies within specified periods before randomization
Splenectomy within 6 months before randomization
Diagnosis of myelodysplastic syndrome or recent malignancy within 5 years
Participation in another clinical trial within 4 weeks or 5 half-lives before randomization except placebo-controlled trials
History of severe recurrent or chronic infection or active systemic infection requiring IV treatment within 4 weeks
Major surgery within 12 weeks before randomization or planned during the study
Severe cardiovascular or cerebrovascular diseases within 6 months or uncontrolled hypertension
HIV infection or active hepatitis B or C
Confirmed active syphilis or tuberculosis infection
Known hypersensitivity to monoclonal antibodies or study product components
Recent live or attenuated live vaccines within 4 weeks before randomization or planned during the study
History of organ or stem cell transplantation
Lactating females
Any condition interfering with compliance or trial participation as judged by investigator

Research Team

Songping Ao

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A Randomized, Double-Blind Study Testing Safety and Effectiveness of SG301 SC Injection in Adults with Primary Immune Thrombocytopenia

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria