NCT04346888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

April 13, 2020

Last Update Submit

March 6, 2023

Conditions

Myasthenia Gravis

Keywords

MG

Outcome Measures

Primary Outcomes (1)

  • Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43

    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)

    43 days

Secondary Outcomes (11)

  • Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43

    43 days

  • Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43

    43 days

  • Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43

    43 days

  • Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43

    43 days

  • Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points

    43 days

  • +6 more secondary outcomes

Study Arms (3)

HBM9161 (680mg and 340 mg)

EXPERIMENTAL

Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg;

Drug: HBM9161 Injection (680mg and 340 mg)

HBM9161 (340 mg)

EXPERIMENTAL

Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg;

Drug: HBM9161 Injection (340 mg)

Placebo, HBM9161 (340 mg)

PLACEBO COMPARATOR

Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg;

Drug: Placebos

Interventions

HBM9161 Injection (680mg and 340 mg)DRUG

HBM9161 Injection (680mg and 340mg)

HBM9161 (680mg and 340 mg)
PlacebosDRUG

Placebo, HBM9161 Injection (340mg)

Placebo, HBM9161 (340 mg)
HBM9161 Injection (340 mg)DRUG

HBM9161 Injection (340 mg)

HBM9161 (340 mg)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form.
  • Male or female ≥ 18 years of age.
  • A female participant is eligible to participate if she is of:
  • Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);
  • 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.
  • A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
  • Meets MGFA myasthenia gravis clinical classification IIa-IVa (includes types IIa, IIb, IIIa, IIIb, and IVa) at the screening visit and at the baseline visit.
  • Screening and baseline MG-ADL score ≥ 6, and \< 50% of them is from ocular muscle.
  • Stable background MG treatments at randomization.
  • Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:
  • History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR
  • History of positive edrophonium chloride test OR
  • Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.

You may not qualify if:

  • Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.
  • Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.
  • Thymectomy performed \< 12 months prior to screening.
  • Total IgG level \<6g/L (at screening).
  • 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.
  • Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).
  • Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Yan C, Duan RS, Yang H, Li HF, Zou Z, Zhang H, Zhou H, Li XL, Zhou H, Jiao L, Chen J, Yin J, Du Q, Lee M, Chen Y, Chen X, Zhao C. Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study. Neurol Ther. 2022 Jun;11(2):815-834. doi: 10.1007/s40120-022-00345-9. Epub 2022 Apr 12.

    PMID: 35412216DERIVED

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

HBM9161

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chongbo Zhao

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
for double-blind period
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

July 23, 2020

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

CN(1)