A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096223
• Other study ID #: 4083-004
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2017
• Last updated: March 25, 2018
• Start date: April 10, 2017
• Est. completion date: February 7, 2018

Study information

• Verified date: March 2018
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• KHK4083
IV administration

Locations

Country	Name	City	State
Japan	Closed information	Sapporo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature		Up to 22 weeks post drug administration
Secondary	Serum KHK4083 concentration		Up to 22 weeks post drug administration
Secondary	Maximum concentration (Cmax)		Up to 22 weeks post drug administration
Secondary	Time to reach Cmax (tmax)		Up to 22 weeks post drug administration
Secondary	Area under the curve (AUC)		Up to 22 weeks post drug administration
Secondary	Anti-KHK4083 antibody production		Up to 22 weeks post drug administration