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Trial record 2 of 4 for:    HBM9161

A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346888
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Harbour BioMed (Guangzhou) Co. Ltd.

Brief Summary:
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: HBM9161 Injection (680mg and 340 mg) Drug: Placebos Drug: HBM9161 Injection (340 mg) Phase 2

Detailed Description:

This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG.

The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBM9161 (680mg and 340 mg)
Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg;
Drug: HBM9161 Injection (680mg and 340 mg)
HBM9161 Injection (680mg and 340mg)

Experimental: HBM9161 (340 mg)
Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg;
Drug: HBM9161 Injection (340 mg)
HBM9161 Injection (340 mg)

Placebo Comparator: Placebo, HBM9161 (340 mg)
Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg;
Drug: Placebos
Placebo, HBM9161 Injection (340mg)




Primary Outcome Measures :
  1. Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43 [ Time Frame: 43 days ]
    The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)


Secondary Outcome Measures :
  1. Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43 [ Time Frame: 43 days ]
    The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.

  2. Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43 [ Time Frame: 43 days ]
    The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).

  3. Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43 [ Time Frame: 43 days ]
    The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity

  4. Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points [ Time Frame: 43 days ]
  5. Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. [ Time Frame: 43 days ]
  6. Change in the MG-ADL score from baseline to Day 120 [ Time Frame: 120 days ]
    The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)

  7. Change in the MGC score from baseline to Day 120 [ Time Frame: 120 days ]
    The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.

  8. Change in the QMG score from baseline to Day 120 [ Time Frame: 120 days ]
    The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).

  9. Change in the MG-QoL15r score from baseline to Day 120 [ Time Frame: 120 days ]
    The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity

  10. Proportion of participants with persistent improvement on the MGC score from baseline to Day 120 [ Time Frame: 120 days ]
    Improvement (decrease) in the MGC score by ≥ 3 points for 6 weeks

  11. Proportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120 [ Time Frame: 120 days ]
    Improvement (decrease) in the MG-ADL Score by ≥ 2 points for 6 weeks



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form.
  2. Male or female ≥ 18 years of age.
  3. A female participant is eligible to participate if she is of:

    1. Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);
    2. Childbearing potential, negative serum pregnancy test results at screening visits, and agree to consistently use acceptable and effective contraceptive methods until 14 days after the final visit.
  4. A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
  5. Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:

    1. History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR
    2. History of positive edrophonium chloride test OR
    3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.

Exclusion Criteria:

  1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.
  2. Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.
  3. Thymectomy performed < 12 months prior to screening.
  4. Total IgG level <6g/L (at screening).
  5. Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate in this study.
  6. Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).
  7. Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
  8. History of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Participants must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies and a negative TB test at screening.

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): NCT04346888


Contacts
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Contact: Chongbo Zhao +86 13701822316 zhao_chongbo@fudan.edu.cn
Contact: Jianying Xi +86 13671669680 xijianying@fudan.edu.cn

Locations
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China, Shanghai
Huashan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Chongbo Zhao    +86 13701822316    zhao_chongbo@fudan.edu.cn   
Sponsors and Collaborators
Harbour BioMed (Guangzhou) Co. Ltd.
Investigators
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Principal Investigator: Chongbo Zhao Huashan Hospital
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Responsible Party: Harbour BioMed (Guangzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04346888    
Other Study ID Numbers: 9161.3
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: August 2020

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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.:
MG
Additional relevant MeSH terms:
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Myasthenia Gravis
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases