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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)

Study category: Skin

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Description

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.

Details
Age

Adult

Eligibility

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 greater or equal to 16 at screening and baseline; IGA score greater or equal to 3 (moderate) at both screening and baseline; BSA greater or equal to 10% at both screening and baseline;

Detailed Eligibility: Inclusion Criteria: 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 greater or equal to 16 at screening and baseline; IGA score greater or equal to 3 (moderate) at both screening and baseline; BSA greater or equal to 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 risks). Exclusion Criteria: 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 greater or equal to 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: less or equal to 2.5 times the upper limit of normal (ULN) Neutrophil count: <1.5?10?/uL 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).

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Elizabeth Wallace

Elizabeth Wallace

Study ID

Protocol Number: 19-0144

ClinicalTrials.gov: NCT03703102

Categories

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