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
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
Treatments tested in this trial
- AK139
- AK139
- AK139
- Placebo
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov