A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: KHK4083

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Sapporo, Japan
    • Closed information

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: KHK4083	Drug: KHK4083; IV administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature	Up to 22 weeks post drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum KHK4083 concentration	Up to 22 weeks post drug administration
Maximum concentration (Cmax)	Up to 22 weeks post drug administration
Time to reach Cmax (tmax)	Up to 22 weeks post drug administration
Area under the curve (AUC)	Up to 22 weeks post drug administration
Anti-KHK4083 antibody production	Up to 22 weeks post drug administration

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2017
• Primary Completion (ACTUAL): February 7, 2018
• Study Completion (ACTUAL): February 7, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Dermatologic Agents; KHK4083
• Other Study ID Numbers: 4083-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No