NCT06383468|RecruitingPhase 3

A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis

a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

Akeso ClinicalTrials.gov

Compare

1 other identifier

AK120-301

Study Type

interventional

Target

420

Locations

1 country

Sites

Timeline

RegisteredApr 2024

StartedApr 2024

CompletionJan 2026

Brief Summary

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

420

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Apr 2024

Geographic Reach

1 country

59 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

April 21, 2024

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed

5 days until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed

Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 21, 2024

Last Update Submit

April 21, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
at week 16

Secondary Outcomes (1)

Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
at week 16

Study Arms (2)

AK120 600mg/300mg

EXPERIMENTAL

AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50.

Drug: AK120

Placebo/AK120 600mg to 300mg

PLACEBO COMPARATOR

placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.

Drug: AK120

Interventions

AK120DRUG

300mg Q2W subcutaneous injection thereafter until week 50.

AK120 600mg/300mgPlacebo/AK120 600mg to 300mg

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects aged ≥18≤75 years old.
Atopic dermatitis (AD) diagnosed at least 1 year before screening.
Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

You may not qualify if:

Acute onset of AD within the first 4 weeks of randomization.
Have participated in any clinical research on AK120 in the past
Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
Received allergen specific immunotherapy within the 3 months before randomization.
Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Contact the study team to confirm eligibility.