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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05528510
Other study ID # CR109228
Secondary ID 2022-000365-41CN
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 13, 2022
Est. completion date October 10, 2025

Study information

Verified date April 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 418
Est. completion date October 10, 2025
Est. primary completion date April 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.
Guselkumab Dose 2
Guselkumab (Dose 2) will be administered as SC injection.
Guselkumab Dose 3
Guselkumab (Dose 3) will be administered as SC injection.
Other:
Placebo
Placebo will be administered as SC injection.

Locations

Country Name City State
Argentina 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 Hospital Privado Universitario de Córdoba Cordoba
Argentina Sanatorio Duarte Quiroz Cordoba
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
Australia 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
Belgium Onze -Lieve-Vrouwziekenhuis Aalst
Belgium CHU Saint-Pierre Brussels
Belgium AZ Delta Roeselare
Brazil Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu) Botucatu
Brazil L2IP Instituto de Pesquisas Clinicas Brasilia
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 Jau
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 Andre
Brazil Kaiser Hospta São José Do Rio Preto
Brazil BR TRIALS-Ensaios Clinicos e Consultoria Ltda Sao Paulo
Brazil Instituto D Or de Pesquisa e Ensino (IDOR) Sao Paulo
Brazil INTEGRAL Pesquisa e Ensino Votuporanga
Bulgaria DCC Convex EOOD Sofia
Bulgaria Medical centre Asklepion Sofia
Bulgaria Medical Center Leo Clinic EOOD Targovishte
Canada Barrie GI Associates Barrie Ontario
Canada Fraser Clinical Trials Inc. New Westminster British Columbia
Canada Royal University Hospital Saskatoon Saskatchewan
China 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 1st affiliated hospital of Anhui Medical University Hefei
China Jinhua municipal central hospital Jinhua
China Lanzhou University Second Hospital Lan Zhou
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 Shi Jia Zhuang Shi
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
Czechia Nemocnice Ceske Budejovice, a.s. Ceske Budejovice
Czechia Gastroenterologie, s.r.o., Hradec Kralove Hradec Kralova
Czechia Artroscan s r o Ostrava
Czechia AXON Clinical s.r.o. Prague
Czechia Synexus Czech s.r.o. Praha 2
Czechia ISCARE a.s. Praha 9
France CHRU Besancon Hopital Jean Minjoz Besancon Cedex
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 Benite
France CHU de Reims Reims Cedex
France Hopital d'Instruction des Armees BEGIN Saint-Mande
France CHU Saint-Etienne - Hopital Nord Saint-Priest en Jarez
France CHU Rangueil Toulouse
France CHU Nancy Brabois Vandoeuvre-Les -nancy
Germany Medizinisches Versorgungszentrum (MVZ) Dachau Dachau
Germany MVZ Sanaklinikum Duisburg Duisburg
Germany Medizinische Hochschule Hannover Hannover
Germany Praxisgemeinschaft Jerichow Jerichow
Germany Staedtisches Klinikum Lueneburg Lueneburg
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Semmelweis Egyetem AOK Budapest
Hungary Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont Debrecen
India 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
Israel Ha'Emek Medical Center Afula
Israel Bnai Zion Medical Center Haifa
Israel Wolfson Medical Center Holon
Israel Lev Talpiot Clinic Jerusalem
Israel Shaare Zedek Medical Center - Jerusalem, ISRAEL Jerusalem
Israel Galilee Medical Center Nahariya
Israel Chaim Sheba Medical Center Ramat Gan
Japan Tokyo Medical and Dental University Hospital Bunkyo-ku
Japan Ginza central clinic Chuo-ku
Japan Sai Clinic, Gastrointestinal and Protology Divisions Fujiidera-shi
Japan Fukuoka University Hospital Fukuoka
Japan Fukushima Medical University Hospital Fukushima
Japan Hachinohe City Hospital Hachinohe
Japan Tokai University Hachioji Hospital Hachioji
Japan Matsuda Hospital Hamamatsu-shi
Japan National Hospital Organization Mito Medical Center Higashiibaraki-gun
Japan Kagoshima IBD Gastroenterology Clinic Kagoshima
Japan Kagoshima University Hospital 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 Chiba-Nishi General Hospital Matsudo
Japan National Hospital Organization Matsumoto Medical Center Matsumoto
Japan Yokoyama IBD Clinic Nagoya
Japan Ishida Clinic of IBD and Gastroenterology Oita
Japan Oita Red Cross Hospital Oita
Japan Okayama Saiseikai General Hospital Okayama
Japan Japanese Red Cross Osaka Hospital Osaka
Japan Kinshukai Infusion Clinic Osaka
Japan Kindai University Hospital Osaka-Sayama
Japan Dokkyo Medical University Hospital Shimotsuga Gun
Japan Tokyo Metropolitan Bokutoh Hospital Sumida-ku
Japan National Hospital Organization Shizuoka Medical Center Sunto-gun
Japan National Center for Global Health and Medicine Tokyo
Japan Juntendo University Hospital Urayasu Urayasu
Japan Kanke Gastrointestinal Clinic Utsunomiya-shi
Japan Yokohama City University Medical Center Yokohama
Jordan Jordan University Hospital Amman
Jordan The Speciality Hospital (TSH) / Advanced Clinical Center Amman
Jordan Irbid Specialty Hospital Aydoun
Jordan King Abdullah University Hospital Irbid
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of National Cancer Center Goyang-Si
Korea, Republic of Chosun university hospital Gwangju
Korea, Republic of Korea University Ansan Hospital Gyeonggi-do
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic university of Korea, ST Vincent Hospital Suwon-si
Malaysia 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
Mexico SCIENTIA Investigacion Clinica SC Chihuahua
Mexico Centro de Investigacion Clinica Acelerada S.C Ciudad de Mexico
Mexico Hospital Médica Sur Tlalpan Ciudad de Mexico
Mexico Clinica de Investigacion en Reumatologia y Obesidad Guadalajara
Mexico Medical Care & Research SA de CV Merida
Mexico Clinicos Asociados BOCM, SC Mexico City
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 Garcia
New Zealand Hutt Hospital Boulcott
New Zealand Christchurch Hospital Christchurch
New Zealand Dunedin Hospital Dunedin
New Zealand Auckland City Hospital Grafton
New Zealand Waikato Hospital Hamilton
Poland 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 Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j. Grudziadz
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 Rzeszow
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland GASTROMED Sp. z o.o. Torun
Poland Gabinety Lekarskie Bodyclinic Warszawa
Poland Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus Warszawa
Poland Melita Medical Sp. z o.o. Wroclaw
Poland Przychodnia Vistamed Wroclaw
Poland Pro Life Medica Sp z o o ETG Zamosc Zamosc
Slovakia FNsP F.D.R. Banska Bystrica Banska Bystrica
Slovakia Cliniq s.r.o. Bratislava
Slovakia ENDOMED s.r.o Kosice
Slovakia KM Management spol. s r.o. Nitra
Spain Hosp. Univ. Germans Trias I Pujol Badalona
Spain Hosp. Virgen Macarena Sevilla
Spain Hosp. de La Marina Baixa Villajoyosa
Spain Hosp. Univ. Miguel Servet Zaragoza
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei City
Turkey Istanbul University Istambul
Turkey Ege University Medical Faculty Izmir
Turkey Mersin University Medical Faculty Mersin
United States Om Research LLC Apple Valley California
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Digestive Healthcare of Georgia, P.C Atlanta Georgia
United States University of North Carolina Chapel Hill North Carolina
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States Gastro Florida Clearwater Florida
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Dayton Gastroenterology, Inc Dayton Ohio
United States Detroit Clinical Research Center Farmington Hills Michigan
United States Peters Medical Research High Point North Carolina
United States Smart Medical Research Hollis New York
United States I.H.S. Health. LLC Kissimmee Florida
United States Om Research LLC Lancaster California
United States Research Solutions of Arizona Litchfield Park Arizona
United States Gastroenterology Associates of Central GA Macon Georgia
United States Columbus Clinical Services LLC Miami Florida
United States Vista Health Research, LLC Miami Florida
United States Care Access Research, Ogden Ogden Utah
United States Gastroenterology Associates of Orangeburg, SC Orangeburg South Carolina
United States Orlando Health Orlando Florida
United States Allegheny General Hospital of Research Pittsburgh Pennsylvania
United States Gastroenterology Associates Salt Lake City Utah
United States Southern Star Research Institute, LLC San Antonio Texas
United States UT Health Science Center at San Antonio San Antonio Texas
United States Medical Associates Research Group, Inc. San Diego California
United States Theia Clincial Research, LLC Temple Terrace Florida
United States Cotton O'Neil Digestive Health Center Topeka Kansas
United States Tyler Research Institute, LLC Tyler Texas
United States Frontier Clinical Research Uniontown Pennsylvania
United States Victoria Gastroenterology Victoria Texas
United States Northshore Gastroenterology Research, LLC Westlake Ohio

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  India,  Israel,  Japan,  Jordan,  Korea, Republic of,  Malaysia,  Mexico,  New Zealand,  Poland,  Slovakia,  Spain,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Remission Clinical remission per modified Mayo score. Week 12
Secondary Symptomatic Remission Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Weeks 12 and 24
Secondary Endoscopic Improvement Endoscopic improvement per Mayo endoscopy subscore. Weeks 12 and 24
Secondary Clinical Response Clinical response per modified Mayo score. Weeks 12 and 24
Secondary Clinical Remission Clinical remission per modified Mayo score. Week 24
Secondary Histologic-Endoscopic Mucosal Improvement Histologic-endoscopic mucosal improvement is defined as a combination of histologic improvement according to the Geboes grading system and endoscopic improvement (Mayo endoscopy subscore of 0 or 1 without friability). Week 12
Secondary Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Up to Week 112
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