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Completed

NCT Number: NCT03096223

A Phase 1 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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Closed information

Sapporo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Any skin disease that may affect the clinical symptom assessment
  • Pregnant or lactating women, or women willing to have a child during the study period

Treatment and study plan

KHK4083

Drug

IV administration

Primary outcomes

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

    Time frame: Up to 22 weeks post drug administration

Secondary outcomes

  1. Serum KHK4083 concentration

    Time frame: Up to 22 weeks post drug administration

  2. Maximum concentration (Cmax)

    Time frame: Up to 22 weeks post drug administration

  3. Time to reach Cmax (tmax)

    Time frame: Up to 22 weeks post drug administration

  4. Area under the curve (AUC)

    Time frame: Up to 22 weeks post drug administration

  5. Anti-KHK4083 antibody production

    Time frame: Up to 22 weeks post drug administration

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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