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

H

Harbour BioMed

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Primary Immune Thrombocytopenic Purpura

Treatments

Drug: HBM9161 Dose A
Drug: HBM9161 Dose B
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04428255
9161.4

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 3 patient groups, including a placebo group

HBM9161 Dose A
Experimental group
Description:
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
Treatment:
Drug: HBM9161 Dose A
HBM9161 Dose B
Experimental group
Description:
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
Treatment:
Drug: HBM9161 Dose B
Placebo
Placebo Comparator group
Description:
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Shuai Zhao

Data sourced from clinicaltrials.gov

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