A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)

NCT ID: NCT06756126

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-06-30

Brief Summary

This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis

Detailed Description

This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK120 300mg every two weeks (Q2W) subcutaneous injection

Subjects with heavy weight

Group Type: EXPERIMENTAL

AK120

Intervention Type: DRUG

AK120 subcutaneous injection

AK120 300mg every three weeks (Q3W) subcutaneous injection

Subjects with light weight

Group Type: EXPERIMENTAL

AK120

Intervention Type: DRUG

AK120 subcutaneous injection

Interventions

AK120

AK120 subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged ≥12 <18 years old.
• Weight≥30kg at baseline.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

Exclusion Criteria

• Acute onset of AD in 4 weeks prior to enrollment.
• Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
• Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
• Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
• Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
• Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dongguan People's Hospital

Dongguan, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

Hunan Pediatric Medical Union

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Ning Bo No.2 Hospital

Ningbo, Zhejiang, China

Countries

China

Central Contacts

Guoqin Wang

Role: CONTACT

global.trials@akesobio.com

86 (0760) 8987 3999

Other Identifiers

AK120-208

Identifier Type: -

Identifier Source: org_study_id