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

NCT04428255 | Completed Phase 2

• 1 other identifier: 9161.4
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Immune Thrombocytopenic Purpura

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve the early response.

  The primary endpoint of phase 2

  7 weeks

Secondary Outcomes (1)

• Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.

  7 weeks

Study Arms (3)

HBM9161 Dose A

EXPERIMENTAL

Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo

Drug: HBM9161 Dose A

HBM9161 Dose B

EXPERIMENTAL

Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo

Drug: HBM9161 Dose B

Placebo

PLACEBO COMPARATOR

Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo

Drug: Placebo

Interventions

HBM9161 Dose A DRUG

HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

HBM9161 Dose A

HBM9161 Dose B DRUG

HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

HBM9161 Dose B

Placebo DRUG

HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Hematology hospital, Chinese academy of medical sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Study Officials

• Renchi Yang

  Hematology hospital, Chinese academy of medical sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 24, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 11, 2021
• Last Updated: April 28, 2026

Record last verified: 2021-08

Locations

CN (1)