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NCT Number: NCT06767540

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

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.

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

placebo subcutaneous injection Q2W until week 46.

Primary outcomes

  1. Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75

    Time frame: at week 18 （day 127)

    At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).

  2. Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points

    Time frame: at week 18 （day 127)

    At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).

Secondary outcomes

  1. Percentage change in affected Body Surface Area (BSA)

    Time frame: week 0 to week 52

    Percentage change in BSA from baseline.

  2. percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores

    Time frame: week 0 to week 52

    percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable).

  3. Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score

    Time frame: week 0 to week 52

    Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.

  4. Incidence of Adverse Events (AE)

    Time frame: week 0 to week 52

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqin Wang

CONTACT

[email protected]

86 (0760) 8987 3999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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 Atopic Dermatitis (AD) in Adolescents

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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