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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 March 2015
• Main ID: NCT01782937
• Date of registration: 27/01/2013
• Prospective Registration: Yes
• Primary sponsor: Kyowa Hakko Kirin Company, Limited
• Public title: An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis
• Scientific title: A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
• Date of first enrolment: February 2013
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01782937
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: KHK4827

Primary Outcome(s)

Clinical Global Impression (CGI) [Time Frame: 52 weeks]

Secondary Outcome(s)

Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [Time Frame: 52 weeks]

Pustular symptom score (only in subjects with pustular psoriasis) [Time Frame: 52 weeks]

Development of anti-KHK4827 antibody [Time Frame: 52 weeks]

Incidence and types of adverse events and adverse reactions [Time Frame: 52 weeks]

Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma) [Time Frame: 52 weeks]

Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma) [Time Frame: 52 weeks]

sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma) [Time Frame: 52 weeks]

American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [Time Frame: 52 weeks]

Laboratory values and vital signs [Time Frame: 52 weeks]

Profiles of pharmacokinetics [Time Frame: 52 weeks]

Secondary ID(s)

4827-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors