Phase 2 Study of KHK4577

NCT02004119 | Completed Phase 2

• 1 other identifier: 4577-002
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  Pre-dose, Week 1,2,4 and 6

Secondary Outcomes (5)

• Change from baseline in Investigator's Global Assessment score

  Pre-dose, Week 1,2,4 and 6

• Dermatology Life Quality Index

  Pre-dose, Week 1,2,4 and 6

• Visual Analog Scale (itching)

  Pre-dose, Week 1,2,4 and 6

• Incidence of patients with adverse events

  From Day 1 through Week 6

• Profile of pharmacokinetics of plasma KHK4577 concentration

  pre-dose, Week 1,2,4 and 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

KHK4577

EXPERIMENTAL

Drug: KHK4577

Interventions

KHK4577 DRUG

KHK4577

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

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

Sapporo, Hokkaido, 060-0063, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 11, 2018

Record last verified: 2018-08

Locations

JP (1)