A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

• Sponsor: Kyowa Kirin Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03096223
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: KHK4083	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis
• Actual Study Start Date: Apr 10, 2017
• Actual Primary Completion Date: Feb 7, 2018
• Actual Study Completion Date: Feb 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KHK4083	Drug: KHK4083; IV administration

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature [Up to 22 weeks post drug administration]

Secondary Outcome Measures

1. Serum KHK4083 concentration [Up to 22 weeks post drug administration]

2. Maximum concentration (Cmax) [Up to 22 weeks post drug administration]

3. Time to reach Cmax (tmax) [Up to 22 weeks post drug administration]

4. Area under the curve (AUC) [Up to 22 weeks post drug administration]

5. Anti-KHK4083 antibody production [Up to 22 weeks post drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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)

2. Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items

3. Past or current history of drug allergy

4. Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment

5. Any planned surgical treatment during the study

6. Any skin disease that may affect the clinical symptom assessment

7. Pregnant or lactating women, or women willing to have a child during the study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Closed information	Sapporo		Japan

Sponsors and Collaborators

• Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyowa Kirin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03096223
• Other Study ID Numbers: 4083-004
• First Posted: Mar 30, 2017
• Last Update Posted: Mar 27, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; KHK4083

Study Results

No Results Posted as of Mar 27, 2018