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

Akeso

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: placebo; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06767540

AK120-302

Details and patient eligibility

About

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

Full description

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.

Enrollment: 198 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.
• AD diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
• Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

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 4 weeks or 5 halflives 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

AK120 600mg every two weeks (Q2W) subcutaneous injection

Experimental group

Description:

AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.

Treatment:

Drug: Placebo

AK120 600mg every three weeks (Q3W) subcutaneous injection

Experimental group

Description:

AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.

Treatment:

Drug: placebo