A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT ID: NCT05528510

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2028-10-06

Brief Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Guselkumab

Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Group Type: EXPERIMENTAL

Guselkumab Dose 1

Intervention Type: DRUG

Guselkumab (Dose 1) will be administered as SC injection.

Guselkumab Dose 2

Intervention Type: DRUG

Guselkumab (Dose 2) will be administered as SC injection.

Group 2: Guselkumab

Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Group Type: EXPERIMENTAL

Guselkumab Dose 1

Intervention Type: DRUG

Guselkumab (Dose 1) will be administered as SC injection.

Guselkumab Dose 3

Intervention Type: DRUG

Guselkumab (Dose 3) will be administered as SC injection.

Group 3: Placebo

Participants will receive matching placebo SC injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be administered as SC injection.

Interventions

Guselkumab Dose 1

Guselkumab (Dose 1) will be administered as SC injection.

Intervention Type: DRUG

Guselkumab Dose 2

Guselkumab (Dose 2) will be administered as SC injection.

Intervention Type: DRUG

Guselkumab Dose 3

Guselkumab (Dose 3) will be administered as SC injection.

Intervention Type: DRUG

Placebo

Placebo will be administered as SC injection.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form
• 18 years of age or older
• Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
• Moderately to severely active UC as per the modified Mayo score
• Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
• Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
• Receiving prohibited medications and treatments
• UC limited to the rectum only
• Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Research Solutions of Arizona

Litchfield Park, Arizona, United States

Om Research LLC

Apple Valley, California, United States

Om Research LLC

Lancaster, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Gastro Florida

Clearwater, Florida, United States

I.H.S. Health. LLC

Kissimmee, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, United States

Vista Health Research, LLC

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Theia Clincial Research, LLC

Temple Terrace, Florida, United States

Digestive Healthcare of Georgia, P.C

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Gastroenterology Associates of Central GA

Macon, Georgia, United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Detroit Clinical Research Center

Farmington Hills, Michigan, United States

Smart Medical Research

Hollis, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Dayton Gastroenterology, Inc

Dayton, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio LLC

Westlake, Ohio, United States

Allegheny General Hospital of Research

Pittsburgh, Pennsylvania, United States

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Gastroenterology Associates of Orangeburg, SC

Orangeburg, South Carolina, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

UT Health Science Center at San Antonio

San Antonio, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Victoria Gastroenterology

Victoria, Texas, United States

Care Access Research, Ogden

Ogden, Utah, United States

Gastroenterology Associates

Salt Lake City, Utah, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Cer Instituto Medico

Buenos Aires, , Argentina

Hospital General de Agudos José Maria Ramos Mejía

Buenos Aires, , Argentina

Clinica Adventista Belgrano

Ciudad de Buenos Aires, , Argentina

Sanatorio Duarte Quiroz

Córdoba, , Argentina

Hospital Privado Universitario De Cordoba

Córdoba, , Argentina

Hospital Italiano de La Plata

La Plata, , Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, , Argentina

Hospital Provincial del Centenario

Rosario, , Argentina

Royal Adelaide Hospital

Adelaide, , Australia

Royal Prince Alfred Hospital

Camperdown, , Australia

Monash Health

Clayton, , Australia

Royal Brisbane and Women's Hospital

Herston, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

Royal Melbourne Hospital

Parkville, , Australia

IBD Clinical Trials Mater Research

South Brisbane, , Australia

The Queen Elizabeth Hospital

Woodville South, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Onze -Lieve-Vrouwziekenhuis

Aalst, , Belgium

CHU Saint-Pierre

Brussels, , Belgium

AZ Delta

Roeselare, , Belgium

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

L2IP Instituto de Pesquisas Clinicas

Brasília, , Brazil

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, , Brazil

CDC - Centro Digestivo de Curitiba

Curitiba, , Brazil

CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

Jaú, , Brazil

Galileo Pesquisa Clinica

Juiz de Fora, , Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, , Brazil

CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

Salvador, , Brazil

Pesquisare Saude

Santo André, , Brazil

Kaiser Hospta

São José do Rio Preto, , Brazil

BR TRIALS Ensaios Clinicos e Consultoria Ltda

São Paulo, , Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, , Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, , Brazil

Medical centre Asklepion

Sofia, , Bulgaria

DCC Convex EOOD

Sofia, , Bulgaria

Medical Center Leo Clinic EOOD

Targovishte, , Bulgaria

Fraser Clinical Trials Inc.

New Westminster, British Columbia, Canada

Barrie GI Associates

Barrie, Ontario, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

China Japan Friendship Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

West China Hospital Sichuan University

Chengdu, , China

Chongqing General Hospital

Chongqing, , China

First Affiliated Hospital of Gannan Medical University

Ganzhou, , China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

ZhuJiang Hospital of Southern Medical University

Guangzhou, , China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, , China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, , China

The First Affiliated Hospital of Anhui Medical University

Hefei, , China

Jinhua municipal central hospital

Jinhua, , China

Lanzhou University Second Hospital

Lanzhou, , China

The first affiliated hospital of Henan University of science and technology

Luoyang, , China

Nanjing Drum Tower Hospital

Nanjing, , China

Zhongda Hospital Southeast University

Nanjing, , China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, , China

Shanghai East Hospital

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

Shenzhen Hospital of Southern Medical University

Shenzhen, , China

The Second Hospital of Hebei Medical University

Shijiazhuang, , China

Taihe Hospital

Shiyan, , China

Renmin Hospital of Wuhan University

Wuhan, , China

Wuxi People s Hospital

Wuxi, , China

General Hospital of Ningxia Medical Hospital

Yinchuan, , China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Nemocnice Ceske Budejovice a s

České Budějovice, , Czechia

Gastroenterologie, s.r.o., Hradec Kralove

Hradec Kralova, , Czechia

Artroscan s r o

Ostrava, , Czechia

Synexus Czech s.r.o.

Prague, , Czechia

AXON Clinical s.r.o.

Prague, , Czechia

ISCARE a.s.

Prague, , Czechia

CHRU Besancon Hopital Jean Minjoz

Besançon, , France

Hopital de Bicetre

Le Kremlin-Bicêtre, , France

CHRU Montpellier - Hopital Saint-Eloi

Montpellier, , France

Clinique Ambroise Pare

Neuilly-sur-Seine, , France

CHU de Nice Hopital de l Archet

Nice, , France

Polyclinique Du Grand Sud

Nîmes, , France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, , France

Hospices Civils de Lyon HCL

Pierre-Bénite, , France

CHU de Reims

Reims, , France

Hopital d'Instruction des Armees BEGIN

Saint-Mandé, , France

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, , France

CHU Rangueil

Toulouse, , France

CHU Nancy Brabois

Vandœuvre-lès-Nancy, , France

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, , Germany

MVZ Sanaklinikum Duisburg

Duisburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Praxisgemeinschaft Jerichow

Jerichow, , Germany

Staedtisches Klinikum Lueneburg

Lüneburg, , Germany

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Semmelweis Egyetem AOK

Budapest, , Hungary

Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

Debrecen, , Hungary

Fortis Memorial Research Institute

Gurugram, , India

Asian Institute Of Gastroenterology

Hyderabad, , India

Kasturba Medical College Hospital

Manipal, , India

P D Hinduja National Hospital and Medical Research Center

Mumbai, , India

SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

Surat, , India

Ha'Emek Medical Center

Afula, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center - Jerusalem, ISRAEL

Jerusalem, , Israel

Lev Talpiot Clinic

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tokyo Medical and Dental University Hospital

Bunkyō City, , Japan

Ginza central clinic

Chūōku, , Japan

Sai Gastroenterology Proctology

Fujiidera-shi, , Japan

Fukuoka University Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Hachinohe City Hospital

Hachinohe, , Japan

Tokai University Hachioji Hospital

Hachiōji, , Japan

Matsuda Hospital

Hamamatsu, , Japan

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, , Japan

National Hospital Organization Kanazawa Medical Center

Kanazawa, , Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, , Japan

Kyushu Rosai Hospital

Kitakyushu, , Japan

Kumagaya General Hospital

Kumagaya-shi, , Japan

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, , Japan

Tokushukai Chiba-Nishi General Hospital

Matsudo, , Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, , Japan

Yokoyama IBD Clinic

Nagoya, , Japan

Okayama Saiseikai General Hospital

Okayama, , Japan

Kinshukai Infusion Clinic

Osaka, , Japan

Japanese Red Cross Osaka Hospital

Osaka, , Japan

Oita Red Cross Hospital

Ōita, , Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, , Japan

Kindai University Hospital

Ōsaka-sayama, , Japan

Dokkyo Medical University Hospital

Shimotsuga Gun, , Japan

Center Hospital of the National Center for Global Health and Medicine

Shinjuku Ku, , Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, , Japan

National Hospital Organization Shizuoka Medical Center

Sunto-gun, , Japan

Juntendo University Hospital Urayasu

Urayasu, , Japan

Kanke Gastrointestinal Clinic

Utsunomiya, , Japan

Yokohama City University Medical Center

Yokohama, , Japan

The Speciality Hospital (TSH) / Advanced Clinical Center

Amman, , Jordan

Jordan University Hospital

Amman, , Jordan

Irbid Specialty Hospital

Aydoun, , Jordan

King Abdullah University Hospital

Irbid, , Jordan

Hospital Selayang

Batu Caves, , Malaysia

Hospital Pulau Pinang

George Town, , Malaysia

Hospital Sultanah Aminah

Johor Bahru, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital Umum Sarawak

Kuching, , Malaysia

Hospital Tuanku Jaafar

Seremban, , Malaysia

SCIENTIA Investigacion Clinica SC

Chihuahua City, , Mexico

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, , Mexico

Clinicos Asociados BOCM, SC

Mexico City, , Mexico

Centro de Investigacion Clinica Acelerada S.C

Mexico City, , Mexico

Hospital Médica Sur Tlalpan

Mexico City, , Mexico

Medical Care & Research SA de CV

Mérida, , Mexico

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, , Mexico

Fundacion Santos Y De La Garza Evia IBP

Monterrey, , Mexico

Clinical Research Institute Saltillo S.A. de C.V.

Saltillo, , Mexico

Oncare

San Pedro Garza García, , Mexico

Hutt Hospital

Boulcott, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

Auckland City Hospital

Grafton, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, , Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Centrum Medyczne Lukamed

Chojnice, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Centrum Medyczne Promed

Krakow, , Poland

Zespol Poradni Specjalistycznych REUMED Filia nr 2

Lublin, , Poland

EMC Instytut Medyczny SA PL CERTUS

Poznan, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

GASTROMED Sp. z o.o.

Torun, , Poland

Bodyclinic Sp. z o.o. sp. k

Warsaw, , Poland

Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Przychodnia Vistamed

Wroclaw, , Poland

Melita Medical Sp. z o.o.

Wroclaw, , Poland

Pro Life Medica Sp z o o ETG Zamosc

Zamość, , Poland

FNsP F.D.R. Banska Bystrica

Banská Bystrica, , Slovakia

Cliniq s.r.o.

Bratislava, , Slovakia

ENDOMED s.r.o

Košice, , Slovakia

KM Management spol. s r.o.

Nitra, , Slovakia

Inje University Haeundae Paik Hospital

Busan, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

National Cancer Center

Goyang-si, , South Korea

Chosun university hospital

Gwangju, , South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

The Catholic university of Korea ST Vincent Hospital

Suwon, , South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Hosp. de La Marina Baixa

Villajoyosa, , Spain

Hosp. Univ. Miguel Servet

Zaragoza, , Spain

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Istanbul University

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; China; Czechia; France; Germany; Hungary; India; Israel; Japan; Jordan; Malaysia; Mexico; New Zealand; Poland; Slovakia; South Korea; Spain; Taiwan; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO1959UCO3004

Identifier Type: OTHER

Identifier Source: secondary_id

2022-000365-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504719-34-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109228

Identifier Type: -

Identifier Source: org_study_id