Atopic Dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : KHK4083
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational mater
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily signed informed consent to participate in the study; 2) Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;; 3) EASI score >= 16 at screening and baseline; 4) IGA score >= 3 (moderate) at both screening and baseline; 5) BSA >= 10% at both screening and baseline; 6) Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks);
Exclusion criteria
Exclusion criteria: 1) Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c >=9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders; 2) Any of the following laboratory abnormalities at screening: - Serum creatinine: >1.5 mg/dL - AST or ALT:>=2.5 times the upper limit of normal (ULN) - Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator; 3) Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percent change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score | — |
Secondary
| Measure | Time frame |
|---|---|
| other - | — |
Countries
Europe, Japan, North America
Outcome results
None listed