A Study of MG-K10 in Subjects With Asthma

NCT05382910 | Unknown Phase 1

• 1 other identifier: MG-K10-AS-2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Absolute Change from baseline in pre-bronchodilator FEV1

  Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 12 week of MG-K10 treatment compared with placebo

  12 week

Secondary Outcomes (16)

• Absolute Change from baseline in pre-bronchodilator FEV1

  4,8,16,20,24,28,32 week

• Percent change from baseline in pre-bronchodilator FEV1

  4,8,16,20,24,28,32 week

• peak morning and evening expiratory flow (PEF)

  4,8,12,16,20,24,28,32 week

• the Annualized rate of severe asthma acute event

  24 weeks and 25 to 32 weeks

• Annualized rate of the event of loss of asthma control (LOAC)

  24 weeks and 25 to 32 weeks

Study Arms (3)

MG-K10 Q2W

EXPERIMENTAL

Received MG-K10 300 mg subcutaneous injection every 2 weeks

Drug: MG-K10

MG-K10 Q4W

EXPERIMENTAL

Received MG-K10 300 mg subcutaneous injection every 4 weeks

Drug: MG-K10; Drug: Placebo

Placebo

PLACEBO COMPARATOR

The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.

Drug: Placebo

Interventions

MG-K10 DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Q2W; MG-K10 Q4W

Placebo DRUG

Placebo

MG-K10 Q4W; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
• second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value;
• Must have experienced at least one severe acute asthma attack within 12 months outbreak event.
• Positive bronchodilator test
• Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment

You may not qualify if:

• Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function
• Subjects with malignant tumor within 5 years
• Received biologics with the same therapeutic purpose within 6 months prior to screening,
• Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nanshan Zhong, Medical PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Cai, bachelor

CONTACT

02151371305; xiaofeng.cai@mabgeek.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: About 180 subjects with moderate-to-severe asthma who meet the inclusion criteria will be selected for this study, according to 1:1:1 Randomly assigned to one of the MG-K10 Q2W group, the MG-K10 Q4W group, and the placebo group, with approximately 60 subjects in each group. The Q2W group will receive MG-K10 300mg subcutaneous injection every 2 weeks; Q4W group will receive MG-K10 300mg subcutaneous injection (every 4 weeks) + 2ml placebo subcutaneous injection ; the placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks. All three groups were followed up for 8 weeks after 24 weeks of treatment.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: July 5, 2022
• Primary Completion: December 20, 2023
• Study Completion: June 20, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)