Clinical trial NCT03703102: Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: AD
eczema
skin diseases
biologics
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2018-10-11
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subcutaneous administration
Primary purpose: TREATMENT

Brief summary: 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 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).

Primary outcomes:
measure: Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
timeFrame: Baseline to Week 16
measure: Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 16
measure: EASI Score at Each Time Point
timeFrame: 56 Weeks
measure: Percent Change From Baseline in EASI Score at Each Time Point
timeFrame: 56 Weeks
measure: Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
timeFrame: 56 Weeks
measure: SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
timeFrame: 56 Weeks
measure: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
timeFrame: 56 Weeks
measure: Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
timeFrame: 56 Weeks
measure: Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
timeFrame: 56 Weeks
measure: Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
timeFrame: 56 Weeks
measure: Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
timeFrame: 56 Weeks
measure: Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
timeFrame: 56 Weeks
measure: Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
timeFrame: 56 Weeks
measure: Dermatology Life Quality Index (DLQI) at Each Time Point
timeFrame: 56 Weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Kyowa Investigational Site US-19
state: California
city: Irvine
country: United States
facility: Kyowa Investigational Site US-17
state: California
city: Los Angeles
country: United States
facility: Kyowa Investigational Site US-09
state: California
city: Santa Ana
country: United States
facility: Kyowa Investigational Site US-05
state: California
city: Aurora
country: United States
facility: Kyowa Investigational Site US-10
state: Colorado
city: Clearwater
country: United States
facility: Kyowa Investigational Site US-14
state: Florida
city: Boston
country: United States
facility: Kyowa Investigational Site US-04
state: Massachusetts
city: New York
country: United States
facility: Kyowa Investigational Site US-01
state: New York
city: Charlotte
country: United States
facility: Kyowa Investigational Site US-20
state: North Carolina
city: Cleveland
country: United States
facility: Kyowa Investigational Site US-11
state: Ohio
city: Portland
country: United States
facility: Kyowa Investigational Site US-08
state: Oregon
city: Dallas
country: United States
facility: Kyowa Investigational Site US-02
state: Texas
city: Galveston
country: United States
facility: Kyowa Investigational Site US-07
state: Texas
city: Markham
country: Canada
facility: Kyowa Investigational Site CA-02
state: Ontario
city: Richmond Hill
country: Canada
facility: Kyowa Investigational Site CA-03
state: Ontario
city: Richmond Hill
country: Canada
facility: Kyowa Investigational Site CA-08
state: Ontario
city: Quebec City
country: Canada
facility: Kyowa Investigational Site CA-07
state: Quebec
city: Quebec City
country: Canada
facility: Kyowa Investigational Site CA-09
state: Quebec
city: Sherbrooke
country: Canada
facility: Kyowa Investigational Site CA-04
state: Quebec
city: Aachen
country: Germany
facility: Kyowa Investigational Site GE-13
city: Berlin
country: Germany
facility: Kyowa Investigational Site GE-07
city: Berlin
country: Germany
facility: Kyowa Investigational Site GE-14
city: Darmstadt
country: Germany
facility: Kyowa Investigational Site GE-08
city: Frankfurt am Main
country: Germany
facility: Kyowa Investigational Site GE-05
city: Hamburg
country: Germany
facility: Kyowa Investigational Site GE-02
city: Hannover
country: Germany
facility: Kyowa Investigational Site GE-11
city: Langenau
country: Germany
facility: Kyowa Investigational Site GE-01
city: Aichi
country: Japan
facility: Kyowa Investigational Site JP-17
city: Aichi
country: Japan
facility: Kyowa Investigational Site JP-27
city: Chiba
country: Japan
facility: Kyowa Investigational Site JP-24
city: Fukuoka
country: Japan
facility: Kyowa Investigational Site JP-08
city: Fukuoka
country: Japan
facility: Kyowa Investigational Site JP-09
city: Fukuoka
country: Japan
facility: Kyowa Investigational Site JP-12
city: Fukuoka
country: Japan
facility: Kyowa Investigational Site JP-19
city: Fukuoka
country: Japan
facility: Kyowa Investigational Site JP-26
city: Gifu
country: Japan
facility: Kyowa Investigational Site JP-14
city: Hokkaido
country: Japan
facility: Kyowa Investigational Site JP-01
city: Hokkaido
country: Japan
facility: Kyowa Investigational Site JP-02
city: Hokkaido
country: Japan
facility: Kyowa Investigational Site JP-04
city: Hokkaido
country: Japan
facility: Kyowa Investigational Site JP-29
city: Ibaraki
country: Japan
facility: Kyowa Investigational Site JP-31
city: Kagoshima
country: Japan
facility: Kyowa Investigational Site JP-10
city: Kagoshima
country: Japan
facility: Kyowa Investigational Site JP-11
city: Kanagawa
country: Japan
facility: Kyowa Investigational Site JP-05
city: Kanagawa
country: Japan
facility: Kyowa Investigational Site JP-06
city: Kanagawa
country: Japan
facility: Kyowa Investigational Site JP-21
city: Mie
country: Japan
facility: Kyowa Investigational Site JP-18
city: Miyagi
country: Japan
facility: Kyowa Investigational Site JP-20
city: Morioka
country: Japan
facility: Kyowa Investigational Site JP-28
city: Shimane
country: Japan
facility: Kyowa Investigational Site JP-25
city: Tochigi
country: Japan
facility: Kyowa Investigational Site JP-15
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-03
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-07
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-13
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-16
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-22
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-23
city: Tokyo
country: Japan
facility: Kyowa Investigational Site JP-30
Study officials:
affiliation: Kyowa Kirin Pharmaceutical International Ltd.
name: Ehsanollah Esfandiari, MD, PhD
role: STUDY_DIRECTOR
References: