Back to results

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

Primary Purpose

Primary Immune Thrombocytopenic Purpura

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HBM9161 Dose A

HBM9161 Dose B

Placebo

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenic Purpura focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hematology hospital, Chinese academy of medical sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

HBM9161 Dose A

HBM9161 Dose B

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients who achieve the early response.

The primary endpoint of phase 2

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04428255

First Posted

June 9, 2020

Last Updated

February 9, 2021

Sponsor

Harbour BioMed (Guangzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04428255

Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 21, 2020 (Actual)

Primary Completion Date

July 17, 2021 (Anticipated)

Study Completion Date

March 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Harbour BioMed (Guangzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Immune Thrombocytopenic Purpura

Keywords

ITP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HBM9161 Dose A

Arm Type

Experimental

Arm Description

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

Arm Title

HBM9161 Dose B

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HBM9161 Dose A

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

HBM9161 Dose B

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients who achieve the early response.

Description

The primary endpoint of phase 2

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuai Zhao

Phone

+86 15901236575

peter.zhao@harbourbiomed.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renchi Yang

Organizational Affiliation

Hematology hospital, Chinese academy of medical sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hematology hospital, Chinese academy of medical sciences

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renchi Yang, doctor

Phone

+86 13512078851

rcyang65@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs