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

NCT07436221 | Not Yet Recruiting Phase 2

• 1 other identifier: AK139-201
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Absolute change from baseline in pre-bronchodilator FEV1

  Up to week 12

• Absolute change and percent change from baseline in FENO

  Up to week 12

Secondary Outcomes (3)

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

  Up to week 4

• Serum AK139 concentration

  Up to week 20

• Immunogenicity characteristics of AK139

  Up to week 20

Study Arms (4)

AK139 regimen 1

EXPERIMENTAL

Drug: AK139

AK139 regimen 2

EXPERIMENTAL

Drug: AK139

AK139 regimen 3

EXPERIMENTAL

Drug: AK139

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

AK139 DRUG

AK139 regimen 1- subcutaneous injection.

AK139 regimen 1

Placebo DRUG

subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Shanghai General Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Guoqin Wang

CONTACT

+86 (0760) 8987 399; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 27, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): February 26, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)