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Not yet recruiting NCT06756126

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

Phase II Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK120.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD

Overview

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.

Interventions

  • Drug AK120
    AK120 subcutaneous injection

Primary outcome measures

  • Incidence of adverse events(AE) [Time frame: week -4 to week 16]
Secondary outcome measures (8)
  • PK evaluation: maximum plasma concentration (Cmax) [Time frame: Baseline till last follow-up visit ( up to day 113)]
  • PK evaluation: time to maximum plasma concentration (Tmax) [Time frame: Baseline till last follow-up visit ( up to day 113)]
  • PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17 [Time frame: Baseline till last follow-up visit ( up to day 113)]
  • Change in Eczema Area and Severity Index (EASI) scores [Time frame: week 0/2/4/8/12/16]
  • Change in affected Body Surface Area (BSA) scores [Time frame: week 0/2/4/8/12/16]
  • Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA) [Time frame: week 0/2/4/8/12/16]
  • Change in Children's Dermatology Life Quality Index (CDLQI) scores [Time frame: week 0/2/4/8/12/16]
  • Change in Patient Oriented Eczema Measure (POEM) scores [Time frame: week 0/2/4/8/12/16]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Dongguan People's Hospital — Dongguan
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The University of Hong Kong - Shenzhen Hospital — Shenzhen
  • Hunan Pediatric Medical Union — Changsha
  • Xiangya Hospital Central South University — Changsha
  • Ning Bo No.2 Hospital — Ningbo

Identifiers

NCT: NCT06756126 · AK120-208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗