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A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
18 Years to N/A
– Voluntarily signed informed consent to participate in the study;
– 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;
– EASI score ≥16 at screening and baseline;
– IGA score ≥3 (moderate) at both screening and baseline;
– BSA ≥10% at both screening and baseline;
– 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
– 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;
– 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)
– Neutrophil count: <1.5×10³/μL- Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;- 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).
Kyowa Kirin Pharmaceutical Development, Inc.
Kyowa Kirin Co., Ltd.
Study Director: Ehsanollah Esfandiari, MD, PhD
Kyowa Kirin Pharmaceutical International Ltd.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03703102