An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

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Kyowa Kirin

Status and phase

Completed
Phase 3

Conditions

Psoriasis

Treatments

Drug: KHK4827

Study type

Interventional

Funder types

Industry

Identifiers

NCT01782937
4827-004

Details and patient eligibility

About

This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

Enrollment

30 patients

Sex

All

Ages

18+ 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 pustular psoriasis or psoriatic erythroderma.
  • Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.

Exclusion criteria

  • Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline.
  • Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
  • Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
  • Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
  • Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
  • Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
  • Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
  • Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
  • Subject has used live vaccine within 3 months of the first dose
  • Subject has previously used an anti-IL-17 biologic therapy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

KHK4827
Experimental group
Treatment:
Drug: KHK4827

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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