A Phase 2 interventional study of AK120 in Atopic Dermatitis, sponsored by Akeso. Completed at 26 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Akeso · Phase 2, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 180 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 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.
Drug: AK120
AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
Drug: AK120
subcutaneous injection every 2 weeks
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 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
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
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
Percentage change in (affected body surface area) BSA score from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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