Clinical trial NCT05382910: A Study of MG-K10 in Subjects With Asthma
Official title: Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Asthma
Keywords: asthma
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
First posted: 2022-05-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.

Eligibility criteria: Inclusion Criteria:

* Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
* 1 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

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Absolute Change from baseline in pre-bronchodilator FEV1
timeFrame: 12 week
Secondary outcomes:
measure: Absolute Change from baseline in pre-bronchodilator FEV1
timeFrame: 4,8,16,20,24,28,32 week
measure: Percent change from baseline in pre-bronchodilator FEV1
timeFrame: 4,8,16,20,24,28,32 week
measure: peak morning and evening expiratory flow (PEF)
timeFrame: 4,8,12,16,20,24,28,32 week
measure: the Annualized rate of severe asthma acute event
timeFrame: 24 weeks and 25 to 32 weeks
measure: Annualized rate of the event of loss of asthma control (LOAC)
timeFrame: 24 weeks and 25 to 32 weeks
measure: Time of the first severe asthma acute event
timeFrame: 32 weeks
measure: Time of first loss of asthma control (LOAC)
timeFrame: 32weeks
measure: asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score
timeFrame: 4, 8, 12, 16, 20, 24, 28, and 32 weeks
measure: Morning/evening asthma symptom score
timeFrame: 24 and 32 week
measure: Daily use of first aid medicine spray
timeFrame: 24 and 32 week
measure: Incidence of Adverse events (AEs)
timeFrame: 32 weeks
measure: Pharmacokinetic concentration
timeFrame: 32 weeks
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: 32 weeks
measure: thymus activation regulated chemokine (TARC)
timeFrame: 32 weeks
measure: serum immunoglobulin E (IgE)
timeFrame: 32 weeks
measure: Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, Medical PhD
role: PRINCIPAL_INVESTIGATOR
References: