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Phase 2 Study of KHK4577

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Kyowa Kirin

Status and phase

Completed
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo
Drug: KHK4577

Study type

Interventional

Funder types

Industry

Identifiers

NCT02004119
4577-002

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

93 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
KHK4577
Experimental group
Treatment:
Drug: KHK4577

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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