AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
DrugAK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
NCT Number: NCT06700499
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
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
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.
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).
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.
Time frame: before drug administration at week 0/4/8/12/16
Assessment of AUC 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.
Akeso
Industry
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
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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