A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

Phase 1

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: KHK4083

• Registration Number: NCT03096223
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Study Start: 2017-04-10
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-25
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK4083	KHK4083	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Closed information; 🇯🇵 Sapporo, Japan