NCT02004119CompletedPhase 2
Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
KHK4577
Experimental
Intervention: KHK4577 (Drug)
Outcomes
Primary Outcomes
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Time Frame: Pre-dose, Week 1,2,4 and 6
Secondary Outcomes
- Dermatology Life Quality Index(Pre-dose, Week 1,2,4 and 6)
- Incidence of patients with adverse events(From Day 1 through Week 6)
- Change from baseline in Investigator's Global Assessment score(Pre-dose, Week 1,2,4 and 6)
- Visual Analog Scale (itching)(Pre-dose, Week 1,2,4 and 6)
- Profile of pharmacokinetics of plasma KHK4577 concentration(pre-dose, Week 1,2,4 and 6)
Investigators
Study Sites (1)
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