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Phase 2 Study of KHK4577

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ClinicalTrials.gov Identifier: NCT02004119
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: KHK4577 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: KHK4577 Drug: KHK4577



Primary Outcome Measures :
  1. Percent improvement from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Pre-dose, Week 1,2,4 and 6 ]

Secondary Outcome Measures :
  1. Change from baseline in Investigator's Global Assessment score [ Time Frame: Pre-dose, Week 1,2,4 and 6 ]
  2. Dermatology Life Quality Index [ Time Frame: Pre-dose, Week 1,2,4 and 6 ]
  3. Visual Analog Scale (itching) [ Time Frame: Pre-dose, Week 1,2,4 and 6 ]
  4. Incidence of patients with adverse events [ Time Frame: From Day 1 through Week 6 ]
  5. Profile of pharmacokinetics of plasma KHK4577 concentration [ Time Frame: pre-dose, Week 1,2,4 and 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has signed voluntarily the written informed consent form to participate in this study.
  • Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
  • Rajka & Langeland criteria of >/= 4.5 at screening visit
  • Investigator's Global Assessment (IGA) score of >/= 3 at screening visit

Exclusion Criteria:

  • Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
  • Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
  • Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
  • Subject has complications / history of drug abuse or alcoholism.
  • Subject has drug allergy or history of allergic reaction to a drug medicine.
  • Subject has a significant concurrent medical conditions as defined in the study protocol.
  • Subject is breast-feeding, pregnant or planning to become pregnant in this 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 ClinicalTrials.gov identifier (NCT number): NCT02004119


Locations
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Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Sapporo, Hokkaido, Japan, 060-0063
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02004119     History of Changes
Other Study ID Numbers: 4577-002
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases