A Phase 3 interventional study of Placebo and placebo in Atopic Dermatitis, sponsored by Akeso. Not yet recruiting at 28 sites in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Akeso · Phase 3, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 198 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.
Drug: Placebo
AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
Drug: placebo
placebo subcutaneous injection Q2W until week 46.
placebo subcutaneous injection Q3W until week 45.
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
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).
Time frame: at week 18 （day 127)
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
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).
Time frame: at week 18 （day 127)
Percentage change in affected Body Surface Area (BSA)
Percentage change in BSA from baseline.
Time frame: week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
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).
Time frame: week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
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.
Time frame: week 0 to week 52
Incidence of Adverse Events (AE)
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: week 0 to week 52
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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