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


Kyowa Kirin Pharmaceutical Development, Inc.
NCT ID: NCT03703102
Last Updated: July 1, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.
  • Location: Not Provided

Official Title

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)

Purpose

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.

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

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 ≥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).

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 ≥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).

Additional Information, Locations & Contacts

Sponsors & Collaborators

Kyowa Kirin Pharmaceutical Development, Inc.

Kyowa Kirin Co., Ltd.

Investigators

Study Director: Ehsanollah Esfandiari, MD, PhD

Kyowa Kirin Pharmaceutical International Ltd.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03703102

Location

Contacts

Kyowa Investigational Site US-17

Irvine, California 92697

United States

Kyowa Investigational Site US-09

Los Angeles, California 90033

United States

Kyowa Investigational Site US-05

Santa Ana, California 92701

United States

Kyowa Investigational Site US-10

Aurora, Colorado 80010

United States

Kyowa Investigational Site US-14

Clearwater, Florida 33756

United States

Kyowa Investigational Site US-13

Indianapolis, Indiana 46256

United States

Kyowa Investigational Site US-04

Boston, Massachusetts 02115

United States

Kyowa Investigational Site US-12

Bronx, New York 10461

United States

Kyowa Investigational Site US-01

New York, New York 10029

United States

Kyowa Investigational Site US-11

Cleveland, Ohio 44106

United States

Kyowa Investigational Site US-08

Portland, Oregon 97239

United States

Kyowa Investigational Site US-18

Johnston, Rhode Island 02919

United States

Kyowa Investigational Site US-02

Dallas, Texas 75230

United States

Kyowa Investigational Site US-07

Galveston, Texas 77555

United States

Kyowa Investigational Site US-16

San Antonio, Texas 78229

United States

Kyowa Investigational Site CA-02

Markham, Ontario

Canada

Kyowa Investigational Site CA-06

Peterborough, Ontario

Canada

Kyowa Investigational Site CA-03

Richmond Hill, Ontario

Canada

Kyowa Investigational Site CA-08

Richmond Hill, Ontario

Canada

Kyowa Investigational Site CA-04

Sherbrooke, Quebec

Canada

Kyowa Investigational Site CA-07

Quebec,

Canada

Kyowa Investigational Site CA-09

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-10

Bonn,

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 GE-11

Hannover,

Germany

Kyowa Investigational Site GE-01

Langenau,

Germany

Kyowa Investigational Site GE-04

Osnabrück,

Germany

Kyowa Investigational Site JP-17

Aichi,

Japan

Kyowa Investigational Site JP-27

Aichi,

Japan

Kyowa Investigational Site JP-24

Chiba,

Japan

Kyowa Investigational Site JP-08

Fukuoka,

Japan

Kyowa Investigational Site JP-09

Fukuoka,

Japan

Kyowa Investigational Site JP-12

Fukuoka,

Japan

Kyowa Investigational Site JP-19

Fukuoka,

Japan

Kyowa Investigational Site JP-26

Fukuoka,

Japan

Kyowa Investigational Site JP-14

Gifu,

Japan

Kyowa Investigational Site JP-01

Hokkaido,

Japan

Kyowa Investigational Site JP-02

Hokkaido,

Japan

Kyowa Investigational Site JP-04

Hokkaido,

Japan

Kyowa Investigational Site JP-29

Hokkaido,

Japan

Kyowa Investigational Site JP-31

Ibaraki,

Japan

Kyowa Investigational Site JP-10

Kagoshima,

Japan

Kyowa Investigational Site JP-11

Kagoshima,

Japan

Kyowa Investigational Site JP-05

Kanagawa,

Japan

Kyowa Investigational Site JP-06

Kanagawa,

Japan

Kyowa Investigational Site JP-21

Kanagawa,

Japan

Kyowa Investigational Site JP-18

Mie,

Japan

Kyowa Investigational Site JP-20

Miyagi,

Japan

Kyowa Investigational Site JP-28

Morioka,

Japan

Kyowa Investigational Site JP-25

Shimane,

Japan

Kyowa Investigational Site JP-15

Tochigi,

Japan

Kyowa Investigational Site JP-03

Tokyo,

Japan

Kyowa Investigational Site JP-07

Tokyo,

Japan

Kyowa Investigational Site JP-13

Tokyo,

Japan

Kyowa Investigational Site JP-16

Tokyo,

Japan

Kyowa Investigational Site JP-22

Tokyo,

Japan

Kyowa Investigational Site JP-23

Tokyo,

Japan

Kyowa Investigational Site JP-30

Tokyo,

Japan