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

Sponsor
Akeso
Study ID
NCT07436221
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Dec 27, 2026
Completion
Feb 26, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AK139 regimen 1
  • Experimental: AK139 regimen 2
  • Experimental: AK139 regimen 3
  • Experimental: Placebo

Primary Outcome Measure

Absolute change from baseline in pre-bronchodilator FEV1 [ Time Frame: Up to week 12 ]

Central Contacts

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