Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment khk4827
Phase phase 3
Sponsor Kyowa Hakko Kirin Company, Limited
Start date March 2013
End date December 2015
Trial size 140 participants
Trial identifier NCT01782924, 4827-003

Summary

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Primary purpose treatment
Arm
(Experimental)
khk4827
(Experimental)
khk4827

Primary Outcomes

Measure
Incidence and types of adverse events and adverse reactions
time frame: 52 weeks
Laboratory values and vital signs
time frame: 52 weeks
Development of anti-KHK4827 antibody
time frame: 52 weeks

Secondary Outcomes

Measure
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
time frame: 52 weeks
A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
time frame: 52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
time frame: 52 weeks
sPGA of "clear (0)"
time frame: 52 weeks
Body surface area involvement (BSA) of lesion
time frame: 52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
time frame: 52 weeks
Profiles of pharmacokinetics
time frame: 52 weeks

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - Subject has voluntarily signed the written informed consent form to participate in this study - Subject has completed the week 12 evaluation of Study 4827-002 Exclusion Criteria: - Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) - Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators

Additional Information

Official title An Extension Study in Subjects With Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Kyowa Hakko Kirin Company, Limited.