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CompletedNCT02004119Updated Sep 11, 2018

Phase 2 Study of KHK4577

A Phase 2 interventional study of KHK4577 and Placebo in Atopic Dermatitis, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 93 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    KHK4577

    Drug: KHK4577

Interventions

  • DrugKHK4577
  • DrugPlacebo
06

What researchers measure

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

07

Study locations

1 site
  • For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
    Sapporo, Hokkaido 060-0063, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02004119
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Dec 6, 2013
Start date
Nov 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Sep 11, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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