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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KHK4083
Placebo
Sponsored by
Kyowa Kirin, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring AD, eczema, skin diseases, biologics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Kyowa Investigational Site US-19
  • Kyowa Investigational Site US-17
  • Kyowa Investigational Site US-09
  • Kyowa Investigational Site US-05
  • Kyowa Investigational Site US-10
  • Kyowa Investigational Site US-14
  • Kyowa Investigational Site US-04
  • Kyowa Investigational Site US-01
  • Kyowa Investigational Site US-20
  • Kyowa Investigational Site US-11
  • Kyowa Investigational Site US-08
  • Kyowa Investigational Site US-02
  • Kyowa Investigational Site US-07
  • Kyowa Investigational Site CA-02
  • Kyowa Investigational Site CA-03
  • Kyowa Investigational Site CA-08
  • Kyowa Investigational Site CA-07
  • Kyowa Investigational Site CA-09
  • Kyowa Investigational Site CA-04
  • Kyowa Investigational Site GE-13
  • Kyowa Investigational Site GE-07
  • Kyowa Investigational Site GE-14
  • Kyowa Investigational Site GE-08
  • Kyowa Investigational Site GE-05
  • Kyowa Investigational Site GE-02
  • Kyowa Investigational Site GE-11
  • Kyowa Investigational Site GE-01
  • Kyowa Investigational Site JP-17
  • Kyowa Investigational Site JP-27
  • Kyowa Investigational Site JP-24
  • Kyowa Investigational Site JP-08
  • Kyowa Investigational Site JP-09
  • Kyowa Investigational Site JP-12
  • Kyowa Investigational Site JP-19
  • Kyowa Investigational Site JP-26
  • Kyowa Investigational Site JP-14
  • Kyowa Investigational Site JP-01
  • Kyowa Investigational Site JP-02
  • Kyowa Investigational Site JP-04
  • Kyowa Investigational Site JP-29
  • Kyowa Investigational Site JP-31
  • Kyowa Investigational Site JP-10
  • Kyowa Investigational Site JP-11
  • Kyowa Investigational Site JP-05
  • Kyowa Investigational Site JP-06
  • Kyowa Investigational Site JP-21
  • Kyowa Investigational Site JP-18
  • Kyowa Investigational Site JP-20
  • Kyowa Investigational Site JP-28
  • Kyowa Investigational Site JP-25
  • Kyowa Investigational Site JP-15
  • Kyowa Investigational Site JP-03
  • Kyowa Investigational Site JP-07
  • Kyowa Investigational Site JP-13
  • Kyowa Investigational Site JP-16
  • Kyowa Investigational Site JP-22
  • Kyowa Investigational Site JP-23
  • Kyowa Investigational Site JP-30

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm E

Arm Description

Subcutaneous administration of placebo

Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)

Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)

Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)

Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)

Outcomes

Primary Outcome Measures

Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Secondary Outcome Measures

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
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Percent Change From Baseline in EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
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
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.

Full Information

First Posted
October 9, 2018
Last Updated
May 13, 2022
Sponsor
Kyowa Kirin, Inc.
Collaborators
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03703102
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin, Inc.
Collaborators
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
AD, eczema, skin diseases, biologics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
subcutaneous administration
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Placebo Comparator
Arm Description
Subcutaneous administration of placebo
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)
Arm Title
Arm E
Arm Type
Experimental
Arm Description
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)
Intervention Type
Drug
Intervention Name(s)
KHK4083
Intervention Description
Anti-OX40 Monoclonal Antibody KHK4083
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
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
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
Description
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
Description
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time Frame
Baseline to Week 16
Title
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
Description
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
Description
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
Description
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
Description
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Description
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Description
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
Description
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Time Frame
Baseline to Week 16
Title
EASI Score at Each Time Point
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time Frame
56 Weeks
Title
Percent Change From Baseline in EASI Score at Each Time Point
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time Frame
56 Weeks
Title
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Description
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).
Time Frame
56 Weeks
Title
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
Description
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time Frame
56 Weeks
Title
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
Description
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time Frame
56 Weeks
Title
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
Description
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)
Time Frame
56 Weeks
Title
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Description
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Time Frame
56 Weeks
Title
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Description
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Time Frame
56 Weeks
Title
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Description
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Time Frame
56 Weeks
Title
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Description
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time Frame
56 Weeks
Title
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Description
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time Frame
56 Weeks
Title
Dermatology Life Quality Index (DLQI) at Each Time Point
Description
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Time Frame
56 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehsanollah Esfandiari, MD, PhD
Organizational Affiliation
Kyowa Kirin Pharmaceutical International Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Kyowa Investigational Site US-19
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Kyowa Investigational Site US-17
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Kyowa Investigational Site US-09
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Kyowa Investigational Site US-05
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Kyowa Investigational Site US-10
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Kyowa Investigational Site US-14
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Kyowa Investigational Site US-04
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Kyowa Investigational Site US-01
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Kyowa Investigational Site US-20
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Kyowa Investigational Site US-11
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Kyowa Investigational Site US-08
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Kyowa Investigational Site US-02
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Kyowa Investigational Site US-07
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Kyowa Investigational Site CA-02
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Kyowa Investigational Site CA-03
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Kyowa Investigational Site CA-08
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Kyowa Investigational Site CA-07
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Kyowa Investigational Site CA-09
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Kyowa Investigational Site CA-04
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Kyowa Investigational Site GE-13
City
Aachen
Country
Germany
Facility Name
Kyowa Investigational Site GE-07
City
Berlin
Country
Germany
Facility Name
Kyowa Investigational Site GE-14
City
Berlin
Country
Germany
Facility Name
Kyowa Investigational Site GE-08
City
Darmstadt
Country
Germany
Facility Name
Kyowa Investigational Site GE-05
City
Frankfurt am Main
Country
Germany
Facility Name
Kyowa Investigational Site GE-02
City
Hamburg
Country
Germany
Facility Name
Kyowa Investigational Site GE-11
City
Hannover
Country
Germany
Facility Name
Kyowa Investigational Site GE-01
City
Langenau
Country
Germany
Facility Name
Kyowa Investigational Site JP-17
City
Aichi
Country
Japan
Facility Name
Kyowa Investigational Site JP-27
City
Aichi
Country
Japan
Facility Name
Kyowa Investigational Site JP-24
City
Chiba
Country
Japan
Facility Name
Kyowa Investigational Site JP-08
City
Fukuoka
Country
Japan
Facility Name
Kyowa Investigational Site JP-09
City
Fukuoka
Country
Japan
Facility Name
Kyowa Investigational Site JP-12
City
Fukuoka
Country
Japan
Facility Name
Kyowa Investigational Site JP-19
City
Fukuoka
Country
Japan
Facility Name
Kyowa Investigational Site JP-26
City
Fukuoka
Country
Japan
Facility Name
Kyowa Investigational Site JP-14
City
Gifu
Country
Japan
Facility Name
Kyowa Investigational Site JP-01
City
Hokkaido
Country
Japan
Facility Name
Kyowa Investigational Site JP-02
City
Hokkaido
Country
Japan
Facility Name
Kyowa Investigational Site JP-04
City
Hokkaido
Country
Japan
Facility Name
Kyowa Investigational Site JP-29
City
Hokkaido
Country
Japan
Facility Name
Kyowa Investigational Site JP-31
City
Ibaraki
Country
Japan
Facility Name
Kyowa Investigational Site JP-10
City
Kagoshima
Country
Japan
Facility Name
Kyowa Investigational Site JP-11
City
Kagoshima
Country
Japan
Facility Name
Kyowa Investigational Site JP-05
City
Kanagawa
Country
Japan
Facility Name
Kyowa Investigational Site JP-06
City
Kanagawa
Country
Japan
Facility Name
Kyowa Investigational Site JP-21
City
Kanagawa
Country
Japan
Facility Name
Kyowa Investigational Site JP-18
City
Mie
Country
Japan
Facility Name
Kyowa Investigational Site JP-20
City
Miyagi
Country
Japan
Facility Name
Kyowa Investigational Site JP-28
City
Morioka
Country
Japan
Facility Name
Kyowa Investigational Site JP-25
City
Shimane
Country
Japan
Facility Name
Kyowa Investigational Site JP-15
City
Tochigi
Country
Japan
Facility Name
Kyowa Investigational Site JP-03
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-07
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-13
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-16
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-22
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-23
City
Tokyo
Country
Japan
Facility Name
Kyowa Investigational Site JP-30
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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