Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 4 for:    KHK4083

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703102
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Kyowa Kirin, Inc.

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE October 22, 2018
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
Percent change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to 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%).
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Percent change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to Week 16 ]
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • 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 [ Time Frame: Baseline to 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%).
  • Change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to 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%).
  • Change and percent change from baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) score [ Time Frame: Baseline to Week 16 ]
    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.
  • Achievement of an Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 [ Time Frame: Baseline to 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) [ Time Frame: Baseline to Week 16 ]
    The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
  • Change and percent change from baseline to Week 16 in pruritus Numerical Rating Scale (NRS) score [ Time Frame: Baseline to Week 16 ]
    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 and percent change from baseline to Week 16 in sleep disturbance Numerical Rating Scale (NRS) score [ Time Frame: Baseline to Week 16 ]
    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) [ Time Frame: Baseline to Week 16 ]
    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.
  • Change and percent change from baseline in Eczema Area and Severity Index (EASI) score at each time point [ Time Frame: 56 Weeks ]
    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%).
  • Achievement of EASI-50, EASI-75, or EASI-90 at each time point [ Time Frame: 56 Weeks ]
    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%).
  • Change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score at each time point [ Time Frame: 56 Weeks ]
    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.
  • 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 [ Time Frame: 56 Weeks ]
    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 [ Time Frame: 56 Weeks ]
    The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
  • Change and percent change from baseline in pruritus Numerical Rating Scale (NRS) score at each time point [ Time Frame: 56 Weeks ]
    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 and percent change from baseline in sleep disturbance Numerical Rating Scale (NRS) score at each time point [ Time Frame: 56 Weeks ]
    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 in Dermatology Life Quality Index (DLQI) at each time point [ Time Frame: 56 Weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
subcutaneous administration
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: KHK4083
    Anti-OX40 Monoclonal Antibody KHK4083
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Placebo Comparator: Arm A
    Subcutaneous administration of placebo
    Intervention: Drug: Placebo
  • Experimental: Arm B
    Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)
    Intervention: Drug: KHK4083
  • Experimental: Arm C
    Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)
    Intervention: Drug: KHK4083
  • Experimental: Arm D
    Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)
    Intervention: Drug: KHK4083
  • Experimental: Arm E
    Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)
    Intervention: Drug: KHK4083
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2020)
274
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
250
Actual Study Completion Date  ICMJE November 12, 2020
Actual Primary Completion Date February 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03703102
Other Study ID Numbers  ICMJE 4083-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kyowa Kirin, Inc.
Study Sponsor  ICMJE Kyowa Kirin, Inc.
Collaborators  ICMJE Kyowa Kirin Co., Ltd.
Investigators  ICMJE
Study Director: Ehsanollah Esfandiari, MD, PhD Kyowa Kirin Pharmaceutical International Ltd.
PRS Account Kyowa Kirin, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP