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

NCT01782937 | Completed Phase 3

• 1 other identifier: 4827-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression (CGI)

  CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened

  52 weeks

Secondary Outcomes (10)

• Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)

  52 weeks

• American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)

  52 weeks

• Pustular symptom score (only in subjects with pustular psoriasis)

  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)

  52 weeks

• sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)

  52 weeks

Study Arms (1)

KHK4827

EXPERIMENTAL

Drug: KHK4827

Interventions

KHK4827 DRUG

140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

KHK4827

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

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

Chiyoda-ku, Tokyo, 100-8185, Japan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 4, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

JP (1)