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A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma

ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAkeso

About this trial

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with asthma at least one year;

Evidence of the reversibility of airflow limitation meets the requirements of the protocol;

Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline;

Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline;

Disqualifiers

Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product;

A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline;

Allergic to any component of the investigational product or intolerant to basis treatment;

Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK139

    Drug

    AK139 regimen 1- subcutaneous injection.

  • AK139

    Drug

    AK139 regimen 2- subcutaneous injection.

  • AK139

    Drug

    AK139 regimen 3- subcutaneous injection.

  • Placebo

    Drug

    subcutaneous injection.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: AK139 regimen 1Experimental treatment 1 intervention
Group B: AK139 regimen 2Experimental treatment 1 intervention
Group C: AK139 regimen 3Experimental treatment 1 intervention
Group D: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absolute change from baseline in pre-bronchodilator FEV1

Time frame
Up to week 12
2

Absolute change and percent change from baseline in FENO

Time frame
Up to week 12

Secondary outcomes

1

Adverse events (AEs), serious adverse events(SAEs)

Time frame
Up to week 4
2

Serum AK139 concentration

Time frame
Up to week 20
3

Immunogenicity characteristics of AK139

Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.

Time frame
Up to week 20

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: