A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

961

Participants

Timeline

Start Date

July 10, 2015

Primary Completion Date

August 10, 2018

Study Completion Date

November 30, 2021

Conditions
Colitis, UlcerativeInflammatory Bowel Diseases
Interventions
DRUG

Placebo IV

Placebo will be administered as intravenous infusion.

DRUG

Placebo SC

Placebo will be administered Subcutaneously.

DRUG

Ustekinumab IV

Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.

DRUG

Ustekinumab SC

Ustekinumab will be administered as subcutaneously.

Trial Locations (247)

Unknown

Birmingham

La Mirada

Los Angeles

Newport Beach

Torrance

Vallejo

Lone Tree

Farmington

Washington D.C.

Gainesville

Largo

Miami

Port Orange

Tampa

Winter Park

Zephyrhills

Atlanta

Decatur

Macon

Suwanee

Idaho Falls

Chicago

Evanston

Urbana

Indianapolis

Pratt

Crestview Hills

Lexington

Louisville

Houma

Shreveport

Columbia

Boston

Ann Arbor

Chesterfield

Troy

Ypsilanti

Rochester

Jackson

Marlton

Morristown

Brooklyn

Mineola

New York

Poughkeepsie

Rochester

The Bronx

Cincinnati

Mentor

Portland

Doylestown

Hershey

Philadelphia

Sayre

Germantown

Nashville

Dallas

Houston

Irving

San Antonio

Southlake

Tyler

Salt Lake City

West Jordan

Chesapeake

Fairfax

Roanoke

Seattle

Bedford

Clayton

Concord

Fitzroy

Five Dock

Garran

Heidelberg

Liverpool

Melbourne

South Brisbane

Salzburg

Vienna

Antwerp

Ghent

Kortrijk

Leuven

Liège

Roeselaere

Pleven

Rousse

Sevlievo

Sofia

Varna

Vancouver

Victoria

Brandon

Winnipeg

Greater Sudbury

London

Montreal

Hradec Králové

Pilsen

Prague

Aarhus

Odense

Amiens

Bordeaux

Lille

Lyon

Marseille

Montpellier

Pierre-Bénite

Reims

Rennes

Saint-Etienne

Toulouse

Berlin

Essen

Freiburg im Breisgau

Hanover

Kiel

Leipzig

Lüneburg

Mannheim

Minden

Münster

Balatonfüred

Békéscsaba

Budapest

Debrecen

Miskolc

Mosonmagyaróvár

Szekszárd

Székesfehérvár

Szombathely

Vác

Beersheba

Haifa

Holon

Jerusalem

Kfar Saba

Nahariya

Petach Tikvah

Tel Aviv

Tel Litwinsky

Ageo-shi

Asahikawa

Bunkyō City

Chiba

Chikushinoshi

Fujiidera

Fukuoka-ken

Higashi-Ibaraki

Hirosaki

Hiroshima

Isesaki

Izumo

Kagoshima

Kahoku

Kobe

Kochi

Kurume

Kyoto

Midori-ku

Nagasaki

Nara

Nishinomiya

Numakunai

Osaka

Ōita

Saga

Saga-ken

Saitama

Sakura

Sapporo

Sendai

Shizuoka

Sunto-gun

Takamatsu

Tokorozawa

Tokyo

Toyama

Toyota

Tsu

Tsuchiura

Wakayama

Yamanashi

Amsterdam

Maastricht

Auckland

Christchurch

Dunedin

Lower Hutt

Milford

Gdansk

Krakow

Lodz

Puławy

Sopot

Szczecin

Warsaw

Wroclaw

Bucharest

Oradea

Romania

Timișoara

Irkutsk

Kazan'

Moscow

Moscva

Novosibirsk

Rostov-on-Don

Ryazan

Saint Petersburg

Stavropol

Ufa

Belgrade

Kragujevac

Niš

Vojvodina

Bratislava

Prešov

Daegu

Guri-si

Seoul

Suwon

Chernivtsi

Dnipropetrovsk

Ivano-Frankivsk

Kharkiv

Kiyv

Kyiv

Lviv

Odesa

Sumy

Uzhhorod

Vinnytsia

Zaporizhzhia

Zhaporozhia

Birmingham

Cambridge

Coventry

Doncaster

Edinburgh

Liverpool

London

Salford

Southampton

Sutton in Ashfield

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02407236 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter