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Trial record 43 of 739 for:    "Dermatitis, Atopic"

A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03096223
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
Kyowa Hakko 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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: KHK4083 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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 : April 10, 2017
Actual Primary Completion Date : February 7, 2018
Actual Study Completion Date : February 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: KHK4083 Drug: KHK4083
IV administration

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03096223

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Closed information
Sapporo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

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Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT03096223     History of Changes
Other Study ID Numbers: 4083-004
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs