Not yet recruiting NCT07436221
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK139, AK139, AK139, Placebo.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug AK139
AK139 regimen 1- subcutaneous injection. - Drug AK139
AK139 regimen 2- subcutaneous injection. - Drug AK139
AK139 regimen 3- subcutaneous injection. - Drug Placebo
subcutaneous injection.
Primary outcome measures
- Absolute change from baseline in pre-bronchodilator FEV1 [Time frame: Up to week 12]
- Absolute change and percent change from baseline in FENO [Time frame: Up to week 12]
Secondary outcome measures (3)
- Adverse events (AEs), serious adverse events(SAEs) [Time frame: Up to week 4]
- Serum AK139 concentration [Time frame: Up to week 20]
- Immunogenicity characteristics of AK139 [Time frame: Up to week 20]
Eligibility criteria
Inclusion criteria
- 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;
- The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product.
Exclusion criteria
- 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;
- Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT07436221 · AK139-201