Back to resultsA Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KHK4083
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
Inclusion Criteria:
- Voluntary written informed consent to participate in the study
- Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
- Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka & Langeland Severity Index
- Investigator Global Assessment(IGA) ≥3 (moderate) at screening
Exclusion Criteria:
Any of the following clinically significant concurrent illnesses:
- Type 1 diabetes
- Poorly controlled type 2 diabetes (HbA1c >8.5%)
- Congestive heart failure (class II to IV of the New York Heart Association classification)
- Myocardial infarction within 1 year
- Unstable angina pectoris within 1 year
- Poorly controlled hypertension (systolic pressure >150 mm Hg or diastolic pressure >90 mm Hg at screening)
- Severe chronic lung diseases requiring oxygen therapy
- Multiple sclerosis or other demyelinating diseases
- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
- Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
- Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
- Past or current history of drug allergy
- Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
- Any planned surgical treatment during the study
- Any skin disease that may affect the clinical symptom assessment
- Pregnant or lactating women, or women willing to have a child during the study period
Sites / Locations
- Closed information
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK4083
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Secondary Outcome Measures
Serum KHK4083 concentration
Maximum concentration (Cmax)
Time to reach Cmax (tmax)
Area under the curve (AUC)
Anti-KHK4083 antibody production
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03096223
Brief Title
A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis
Official Title
A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK4083
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK4083
Intervention Description
IV administration
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Time Frame
Up to 22 weeks post drug administration
Secondary Outcome Measure Information:
Title
Serum KHK4083 concentration
Time Frame
Up to 22 weeks post drug administration
Title
Maximum concentration (Cmax)
Time Frame
Up to 22 weeks post drug administration
Title
Time to reach Cmax (tmax)
Time Frame
Up to 22 weeks post drug administration
Title
Area under the curve (AUC)
Time Frame
Up to 22 weeks post drug administration
Title
Anti-KHK4083 antibody production
Time Frame
Up to 22 weeks post drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary written informed consent to participate in the study
Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka & Langeland Severity Index
Investigator Global Assessment(IGA) ≥3 (moderate) at screening
Exclusion Criteria:
Any of the following clinically significant concurrent illnesses:
Type 1 diabetes
Poorly controlled type 2 diabetes (HbA1c >8.5%)
Congestive heart failure (class II to IV of the New York Heart Association classification)
Myocardial infarction within 1 year
Unstable angina pectoris within 1 year
Poorly controlled hypertension (systolic pressure >150 mm Hg or diastolic pressure >90 mm Hg at screening)
Severe chronic lung diseases requiring oxygen therapy
Multiple sclerosis or other demyelinating diseases
Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
Past or current history of drug allergy
Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
Any planned surgical treatment during the study
Any skin disease that may affect the clinical symptom assessment
Pregnant or lactating women, or women willing to have a child during the study period
Facility Information:
Facility Name
Closed information
City
Sapporo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis
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