NCT01748539

Brief Summary

This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

December 10, 2012

Last Update Submit

September 3, 2013

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12

    12 weeks

Secondary Outcomes (8)

  • PASI 75 at Week 12

    12 Weeks

  • PASI 50, 90 and 100 at Week 12

    12 weeks

  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12

    12 Weeks

  • sPGA of "clear (0)" at Week 12

    12 weeks

  • Body surface area involvement (BSA) of lesion at Week 12

    12 weeks

  • +3 more secondary outcomes

Study Arms (4)

KHK4827 70mg SC

EXPERIMENTAL
Drug: KHK4827

KHK4827 140mg SC

EXPERIMENTAL
Drug: KHK4827

KHK4827 210mg SC

EXPERIMENTAL
Drug: KHK4827

Placebo SC

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KHK4827DRUG
KHK4827 140mg SCKHK4827 210mg SCKHK4827 70mg SC
PlaceboDRUG
Placebo SC

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
  • 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.
  • Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

You may not qualify if:

  • Subject diagnosed with erythrodermic psoriasis, pustular 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 investigational product 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 the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus
  • , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)
  • Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy
  • Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines
  • Subject has used ustekinumab within 6 months of the first dose
  • Subject has previously used an anti-interleukin-17 biologic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chiyoda-ku, Tokyo, Japan

Location

Related Publications (1)

  • Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24.

    PMID: 26547109DERIVED

MeSH Terms

Interventions

brodalumab

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

JP(1)