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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428255
Recruitment Status : Unknown
Verified February 2021 by Harbour BioMed (Guangzhou) Co. Ltd..
Recruitment status was:  Recruiting
First Posted : June 11, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Harbour BioMed (Guangzhou) Co. Ltd.

Study Description
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Brief Summary:
To select a dose and to make a decision for Phase 3 study

Condition or disease Intervention/treatment Phase
Primary Immune Thrombocytopenic Purpura Drug: HBM9161 Dose A Drug: HBM9161 Dose B Drug: Placebo Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 17, 2021
Estimated Study Completion Date : March 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HBM9161 Dose A
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 A or Dose B) or matching placebo will be administered IV weekly
Experimental: HBM9161 Dose B
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
 Drug: HBM9161 Dose B
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
Placebo Comparator: Placebo
Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo
 Drug: Placebo
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who achieve the early response. [ Time Frame: 7 weeks ]
    The primary endpoint of phase 2


Secondary Outcome Measures :
  1. Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks. [ Time Frame: 7 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years of age at the screening visit, male or female.
  2. 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.
  3. 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.
  4. 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:

  1. Other autoimmune systemic diseases other than ITP.
  2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
  3. Secondary ITP.
  4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
  5. 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.
  6. Received blood transfusion within 1 week prior to the first dose of the study drug.
  7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
  8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
  9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
  10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
  11. Treated with splenectomy within 4 weeks prior to first dose of the study drug.
  12. Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
  13. Serum total IgG < 700 mg/dL at the screening visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428255


Contacts
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Contact: Shuai Zhao +86 15901236575 peter.zhao@harbourbiomed.com

Locations
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China, Tianjin
Hematology hospital, Chinese academy of medical sciences Recruiting
Tianjin, Tianjin, China, 300020
Contact: Renchi Yang, doctor    +86 13512078851    rcyang65@163.com   
Sponsors and Collaborators
Harbour BioMed (Guangzhou) Co. Ltd.
Investigators
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Principal Investigator: Renchi Yang Hematology hospital, Chinese academy of medical sciences
  Study Documents (Full-Text)

Documents provided by Harbour BioMed (Guangzhou) Co. Ltd.:
Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2020

More Information
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Responsible Party: Harbour BioMed (Guangzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04428255    
Other Study ID Numbers: 9161.4
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harbour BioMed (Guangzhou) Co. Ltd.:
ITP
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
 Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases