Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03703102

Run by

Kyowa Kirin, Inc.

People needed

274

Starts

2018-10-22

Expected to finish

2020-11-12

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 risks).

You may not qualify if…

• 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).

Where it is running

• Kyowa Investigational Site US-17 — Irvine, California, United States
• Kyowa Investigational Site US-09 — Los Angeles, California, United States
• Kyowa Investigational Site US-05 — Santa Ana, California, United States
• Kyowa Investigational Site US-10 — Aurora, Colorado, United States
• Kyowa Investigational Site US-14 — Clearwater, Florida, United States
• Kyowa Investigational Site US-04 — Boston, Massachusetts, United States
• Kyowa Investigational Site US-01 — New York, New York, United States
• Kyowa Investigational Site US-20 — Charlotte, North Carolina, United States
• Kyowa Investigational Site US-11 — Cleveland, Ohio, United States
• Kyowa Investigational Site US-08 — Portland, Oregon, United States
• Kyowa Investigational Site US-02 — Dallas, Texas, United States
• Kyowa Investigational Site US-07 — Galveston, Texas, United States
• Kyowa Investigational Site CA-02 — Markham, Ontario, Canada
• Kyowa Investigational Site CA-03 — Richmond Hill, Ontario, Canada
• Kyowa Investigational Site CA-08 — Richmond Hill, Ontario, Canada
• Kyowa Investigational Site CA-07 — Québec, Quebec, Canada
• Kyowa Investigational Site CA-09 — Québec, Quebec, Canada
• Kyowa Investigational Site CA-04 — Sherbrooke, Quebec, Canada
• Kyowa Investigational Site GE-13 — Aachen, Germany
• Kyowa Investigational Site GE-07 — Berlin, Germany
• Kyowa Investigational Site GE-14 — Berlin, Germany
• Kyowa Investigational Site GE-08 — Darmstadt, Germany
• Kyowa Investigational Site GE-05 — Frankfurt am Main, Germany
• Kyowa Investigational Site GE-02 — Hamburg, Germany
• Kyowa Investigational Site US-19 — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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