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

NCT06756126 | Not Yet Recruiting Phase 2

• 1 other identifier: AK120-208
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events(AE)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  week -4 to week 16

Secondary Outcomes (8)

• PK evaluation: maximum plasma concentration (Cmax)

  Baseline till last follow-up visit ( up to day 113)

• PK evaluation: time to maximum plasma concentration (Tmax)

  Baseline till last follow-up visit ( up to day 113)

• PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17

  Baseline till last follow-up visit ( up to day 113)

• Change in Eczema Area and Severity Index (EASI) scores

  week 0/2/4/8/12/16

• Change in affected Body Surface Area (BSA) scores

  week 0/2/4/8/12/16

Study Arms (2)

AK120 300mg every two weeks (Q2W) subcutaneous injection

EXPERIMENTAL

Subjects with heavy weight

Drug: AK120

AK120 300mg every three weeks (Q3W) subcutaneous injection

EXPERIMENTAL

Subjects with light weight

Drug: AK120

Interventions

AK120 DRUG

AK120 subcutaneous injection

AK120 300mg every three weeks (Q3W) subcutaneous injection; AK120 300mg every two weeks (Q2W) subcutaneous injection

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (6)

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Hunan Pediatric Medical Union

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Ning Bo No.2 Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Guoqin Wang

CONTACT

86 (0760) 8987 3999; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)