Atopic Dermatitis
Conditions
Interventions
Oral administration of KT-621 or matching Placebo QD
Sponsors
Watanabe Toshiyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 12 to 75 years of age, inclusive, at the time of signing the informed consent form (ICF) or informed assent form (IAF) - Chronic AD that has been present for at least 3 years (for participants >= 18 years of age) or 1 year (for participants = 16 at the Screening and Baseline visit - vIGA-AD score >= 3 (scale of 0 to 4) at the Screening and Baseline visits - At least 10% BSA of AD involvement at the Screening and Baseline visits - Weekly average Peak Pruritus NRS >= 4 at the Baseline visit - History within the 6 months prior to the Baseline visit of either an inadequate response to, or contraindication to topical medications for the treatment of AD - Application of a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit
Exclusion criteria
Exclusion criteria: - An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks prior to Baseline. - Known history of, or suspected, significant current immunosuppression, including a history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration - Clinically significant history or evidence of any active or suspected parasitic infection within 4 weeks of the Baseline visit, or travel within the 3 months before baseline to areas of high parasitic exposure, as determined by local or international health guidelines or epidemiological data - Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks of the Baseline visit, or superficial skin infections within 1 week of the Baseline visit - Presence of other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments - Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures - Prohibited therapy received within a specified time frame prior to the Baseline visit - History of inadequate response to any therapeutic agent targeting IL-4, IL-13, and/or the JAK-STAT pathway (eg, dupilumab, lebrikizumab, upadacitinib, abrocitinib) at approved doses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Week 16 in the EASI score | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of participants with EASI-75 at Week 16 - Proportion of participants who achieve a vIGA-AD score of 0 to 1 (on a 5-point scale) and a reduction from baseline of at least 2 points at Week 16 - Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16 - Proportion of participants with EASI-90 at Week 16 - Proportion of participants with EASI-50 at Week 16 - Percentage change from baseline to Week 16 in Peak Pruritus NRS score - Percentage change from baseline to Week 16 in BSA affected by AD - Percentage change from baseline to Week 16 in the SCORAD score - Change from baseline to Week 16 in the POEM - Change from baseline to Week 16 in the DLQI | — |
Countries
Australia, Canada, Czech Republic, Germany, Japan, Poland, South Korea, United States of America
Contacts
Public ContactToshiyo Watanabe
PPD-SNBL K.K.
Outcome results
None listed