A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

PHASE3CompletedINTERVENTIONAL
Enrollment

872

Participants

Timeline

Start Date

October 7, 2014

Primary Completion Date

December 25, 2015

Study Completion Date

May 24, 2016

Conditions
Psoriasis
Interventions
DRUG

Ustekinumab

45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.

DRUG

Guselkumab

100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.

DRUG

Placebo for ustekinumab

Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.

DRUG

Placebo for guselkumab

Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Trial Locations (85)

Unknown

Birmingham

Bakersfield

Los Angeles

Santa Monica

Coral Gables

Ocala

Alpharetta

Atlanta

Arlington Heights

Chicago

Skokie

Indianapolis

Plainfield

Louisville

Boston

Troy

Buffalo

New York

Portland

Pittsburgh

Johnston

Nashville

Arlington

Austin

Dallas

San Antonio

Webster

Norfolk

Spokane

Fremantle

Victoria Park

Woden

Woolloongabba

Surrey

Vancouver

Moncton

Halifax

Ajax

Richmond Hill

Montreal

Québec

Berlin

Bonn

Essen

Gera

Hamburg

Leipzig

Lübeck

Mahlow

Münster

Witten

Bialystok

Bydgoszcz

Gdansk

Krakow

Lodz

Lublin

Olsztyn

Poznan

Torun

Warsaw

Wroclaw

Chelyabinsk

Krasnodar

Lipetsk

Saint Petersburg

Stavropol

Ufa

Yekaterinburg

Anyang

Incheon

Seoul

A Coruña

Alcorcón

Alicante

Barcelona

Madrid

Taichung

Tainan City

Taipei

Taoyuan District

Dudley

Dundee

London

Salford

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02203032 - A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab | Biotech Hunter | Biotech Hunter