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

Akeso

Status and phase: Not yet enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: AK120

Study type: Interventional

Funder types: Industry

Identifiers

NCT06756126

AK120-208

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

AK120 300mg every two weeks (Q2W) subcutaneous injection

Experimental group

Description:

Subjects with heavy weight

Treatment:

Drug: AK120

AK120 300mg every three weeks (Q3W) subcutaneous injection

Experimental group

Description:

Subjects with light weight

Treatment:

Drug: AK120