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Completed

NCT Number: NCT02004119

Phase 2 Study of KHK4577

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic 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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Sapporo, Hokkaido, 060-0063, Japan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

KHK4577

Drug

Placebo

Drug

Primary outcomes

  1. Percent improvement from baseline in Eczema Area and Severity Index (EASI)

    Time frame: Pre-dose, Week 1,2,4 and 6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Sep 11, 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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