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AsthmaPhase 1/2NCT05382910

A Study of MG-K10 in Subjects With Asthma

A Phase 1/2 study testing MG-K10 in people with Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
MG-K10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
5 Jul 2022to 20 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Xiaofeng Cai, bachelor contact

02151371305

xiaofeng.cai@mabgeek.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Jing Li, Medical Ph.D

    Recruiting

Other trials in China

About this study

Official title: Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects

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.

Read the 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.

Conditions
Asthma
Being tested
MG-K10, Placebo
Keywords
asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MG-K10Drug

    MG-K10 Humanized Monoclonal Antibody Injection

  • PlaceboDrug

    Placebo

Study groups in NCT05382910
Study groupRoleWhat they receive
MG-K10 Q2WExperimentalReceived MG-K10 300 mg subcutaneous injection every 2 weeks
Receives: Drug: MG-K10
MG-K10 Q4WExperimentalReceived MG-K10 300 mg subcutaneous injection every 4 weeks
Receives: Drug: MG-K10; Drug: Placebo
PlaceboPlacebo comparatorThe placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 week

Secondary outcomes (16)

  1. Absolute Change from baseline in pre-bronchodilator FEV1

    Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 4,8,16,20,24,28,32 week of MG-K10 treatment compared with placebo

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

  2. Percent change from baseline in pre-bronchodilator FEV1

    at 4,8,16,20,24,28,32 week of MG-K10 treatment compared with placebo，Percent change from baseline in pre-bronchodilator FEV1

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

  3. peak morning and evening expiratory flow (PEF)

    Change from peak morning and evening expiratory flow (PEF) compared with baseline (absolute and percentage)

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

  4. the Annualized rate of severe asthma acute event

    The annualized rate of severe asthma acute event within 24 weeks and 25 to 32 weeks of treatment

    Measured: 24 weeks and 25 to 32 weeks

  5. Annualized rate of the event of loss of asthma control (LOAC)

    the annualized rate of the event of loss of asthma control (LOAC) at 24 weeks and 25 to 32 weeks of treatment

    Measured: 24 weeks and 25 to 32 weeks

  6. Time of the first severe asthma acute event

    Time of the first severe asthma acute event

    Measured: 32 weeks

  7. Time of first loss of asthma control (LOAC)

    Time of first loss of asthma control (LOAC)

    Measured: 32weeks

  8. asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score

    There are 5 questions in ACQ5, It is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control

    Measured: 4, 8, 12, 16, 20, 24, 28, and 32 weeks

  9. Morning/evening asthma symptom score

    Patients will record total symptom scores in morning（a 0-4 scale, with 0=no symptoms, 4=inability to fall asleep at night due to symptoms) and evening (a 0-4 scale, with 0=no symptoms, 4=severe symptoms, unable to work or perform daily activities)

    Measured: 24 and 32 week

  10. Daily use of first aid medicine spray

    Daily use of first aid medicine spray compared with baseline

    Measured: 24 and 32 week

  11. Incidence of Adverse events (AEs)

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing

    Measured: 32 weeks

  12. Pharmacokinetic concentration

    To evaluate the Pharmacokinetic concentration of MG-K10 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model

    Measured: 32 weeks

  13. Fractional exhaled nitric oxide (FeNO)

    At each evaluation time point, the changes of Fractional exhaled nitric oxide(FeNO) were compared with baseline in each group

    Measured: 32 weeks

  14. thymus activation regulated chemokine (TARC)

    At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline in each group

    Measured: 32 weeks

  15. serum immunoglobulin E (IgE)

    At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline in each group

    Measured: 32 weeks

  16. Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)

    Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start5 Jul 2022
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382910
Sponsor's protocol ID
MG-K10-AS-2
Status last verified
Aug 2023
First submitted
11 May 2022
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xian M, Shi X, Li R, Zhao L, Zhuan B, Chen B, Shi H, Wang Z, Wu F, Guo J, Chen Y, Dang W, Guo J, Qin D, Zhang C, Li J, Zhong N. Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Ralpha, in Adult Chinese Patients With Asthma. Clin Exp Allergy. 2026 May 29. doi: 10.1111/cea.70345. Online ahead of print.

    PubMed 42212541

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MG-K10 in people with Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaofeng Cai, bachelor (02151371305, xiaofeng.cai@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change from baseline in pre-bronchodilator FEV1 (time frame: 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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