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NCT Number: NCT06700499

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, Beijing Municipality, China

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About this study

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 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 who are suitable for continue using biological treatment assessed by investigator

Exclusion criteria

  • Acute onset of AD within 4 weeks before drug administration.
  • The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
  • Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
  • Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
  • Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
  • any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.

Treatment and study plan

AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)

Drug

AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: through study completion, an average of 25 weeks

    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. Eczema Area and Severity Index (EASI) score

    Time frame: baseline to week 20

    Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema.

  2. Investigator's Global Assessment (IGA) 0/1

    Time frame: from baseline to week 20

    Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  3. Affected body surface area (BSA) score

    Time frame: from baseline to week 20

    Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined.

  4. Area under the curve(AUC) of AK120

    Time frame: before drug administration at week 0/4/8/12/16

    Assessment of AUC of AK120.

  5. Anti-drug antibodies (ADA) of AK120

    Time frame: before drug administration at week 0/4/8/16/20

    Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Mar 17, 2026

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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