A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

NCT03096223 | Completed Phase 1 DMC

• 1 other identifier: 4083-004
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature

  Up to 22 weeks post drug administration

Secondary Outcomes (5)

• 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

Study Arms (1)

KHK4083

EXPERIMENTAL

Drug: KHK4083

Interventions

KHK4083 DRUG

IV administration

KHK4083

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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)
• Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
• Past or current history of drug allergy
• Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
• Any planned surgical treatment during the study

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Closed information

Sapporo, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

KHK4083

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 30, 2017
• Study Start: April 10, 2017
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

JP (1)