Clinical trial NCT03096223: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-30
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Voluntary written informed consent to participate in the study
2. 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
3. Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka \& Langeland Severity Index
4. Investigator Global Assessment(IGA) ≥3 (moderate) at screening

Exclusion Criteria:

1. 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)
2. 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)
3. Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
4. Past or current history of drug allergy
5. Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
6. Any planned surgical treatment during the study
7. Any skin disease that may affect the clinical symptom assessment
8. Pregnant or lactating women, or women willing to have a child during the study period

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
timeFrame: Up to 22 weeks post drug administration
Secondary outcomes:
measure: Serum KHK4083 concentration
timeFrame: Up to 22 weeks post drug administration
measure: Maximum concentration (Cmax)
timeFrame: Up to 22 weeks post drug administration
measure: Time to reach Cmax (tmax)
timeFrame: Up to 22 weeks post drug administration
measure: Area under the curve (AUC)
timeFrame: Up to 22 weeks post drug administration
measure: Anti-KHK4083 antibody production
timeFrame: Up to 22 weeks post drug administration
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Closed information
Study officials:
References: