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NCT Number: NCT06092762

A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

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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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 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 ≥18≤75 years old.
  • Atopic dermatitis (AD) diagnosed at least half a year before screening.
  • Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
  • Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months

Exclusion criteria

  • Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
  • 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)
  • Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
  • Received allergen specific immunotherapy within the 3 months before randomization.
  • Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Treatment and study plan

AK120

Drug

subcutaneous injection every 2 weeks

Primary outcomes

  1. Incidence of adverse events(AE)

    Time frame: week 0 to week 24

    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

Secondary outcomes

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

    Time frame: at week 2/4/8/12/16 /20 and 24

  2. Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50

    Time frame: at week 2/4/8/12/16 /20 and 24

  3. Percentage change in (Eczema Area and Severity Index) EASI scores from baseline

    Time frame: at week 2/4/8/12/16 /20 and 24

  4. Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA

    Time frame: at week 2/4/8/12/16 /20 and 24

  5. Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline

    Time frame: at week 2/4/8/12/16 /20 and 24

  6. Percentage change in (affected body surface area) BSA score from baseline

    Time frame: at week 2/4/8/12/16 /20 and 24

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Nov 25, 2024

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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