A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

PHASE3CompletedINTERVENTIONAL
Enrollment

992

Participants

Timeline

Start Date

November 3, 2014

Primary Completion Date

October 1, 2015

Study Completion Date

July 1, 2020

Conditions
Psoriasis
Interventions
DRUG

Guselkumab 100 mg

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

DRUG

Placebo for guselkumab

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

DRUG

Adalimumab

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.

DRUG

Placebo for adalimumab

Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).

Trial Locations (93)

Unknown

Birmingham

Bakersfield

Los Angeles

San Diego

Santa Monica

Aurora

Coral Gables

Tampa

Newnan

Sandy Springs

Chicago

Rolling Meadows

Skokie

Indianapolis

Plainfield

Louisville

Andover

Fort Gratiot

Troy

St Louis

Albuquerque

New York

Gahanna

Norman

Portland

Pittsburgh

Johnston

Arlington

Houston

Salt Lake City

Seattle

Spokane

Benowa

Hectorville

Melbourne

Parkville

Westmead

Woolloongabba

Barrie

Hamilton

Mississauga

Ottawa

Richmond Hill

Toronto

Waterloo

Windsor

Jihlava

Náchod

Pardubice

Pilsen

Prague

Ústí nad Labem

Dresden

Gera

Hamburg

Kiel

Leipzig

Lübeck

Münster

Tübingen

Witten

Bialystok

Bydgoszcz

Gdansk

Krakow

Lodz

Lublin

Olsztyn

Poznan

Torun

Warsaw

Wroclaw

Chelyabinsk

Cherepovets

Moscow

Rostov-on-Don

Ryazan

Saint Petersburg

Yaroslavl

Busan

Daejeon

Gwangju

Incheon

Seongnam

Seoul

Suwon

Badalona

Barcelona

Bilbao Vizcaya

Madrid

Murcia

Pontevedra

Valencia

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02207244 - A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment | Biotech Hunter | Biotech Hunter