A Study of MG-K10 in Subjects With Asthma

Shanghai Mabgeek Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: MG-K10

Study type: Interventional

Funder types: Other

Identifiers

NCT05382910

MG-K10-AS-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

MG-K10 Q2W

Experimental group

Description:

Received MG-K10 300 mg subcutaneous injection every 2 weeks

Treatment:

Drug: MG-K10

MG-K10 Q4W

Experimental group

Description:

Received MG-K10 300 mg subcutaneous injection every 4 weeks

Treatment:

Drug: Placebo

Drug: MG-K10

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo