A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

  • STATUS
    Recruiting
  • End date
    Mar 11, 2023
  • participants needed
    36
  • sponsor
    Harbour BioMed (Guangzhou) Co. Ltd.
Updated on 17 February 2021

Summary

To select a dose and to make a decision for Phase 3 study

Description

The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.

Details
Condition Primary Immune Thrombocytopenic Purpura
Treatment Placebo, HBM9161 Dose A, HBM9161 Dose B
Clinical Study IdentifierNCT04428255
SponsorHarbour BioMed (Guangzhou) Co. Ltd.
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years of age at the screening visit, male or female
Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is < 30 10^9/L, and not > 35 10^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit
Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy
Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag

Exclusion Criteria

Other autoimmune systemic diseases other than ITP
Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia
Secondary ITP
Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study
Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug
Received blood transfusion within 1 week prior to the first dose of the study drug
Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug
Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug
Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug
Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug
Treated with splenectomy within 4 weeks prior to first dose of the study drug
Any thromboembolic or embolic events within 12 months prior to the first does of the study drug
Serum total IgG < 700 mg/dL at the screening visit
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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