Clinical trial NCT05528510: A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Guselkumab
Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Clinical Remission
timeFrame: Week 12
Secondary outcomes:
measure: Symptomatic Remission
timeFrame: Weeks 12 and 24
measure: Endoscopic Improvement
timeFrame: Weeks 12 and 24
measure: Clinical Response
timeFrame: Weeks 12 and 24
measure: Clinical Remission
timeFrame: Week 24
measure: Histologic-Endoscopic Mucosal Improvement
timeFrame: Week 12
measure: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 268
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona
state: Arizona
city: Apple Valley
country: United States
facility: Om Research LLC
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Kissimmee
country: United States
facility: I.H.S. Health. LLC
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services LLC
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Temple Terrace
country: United States
facility: Theia Clincial Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia, P.C
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central GA
state: Georgia
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Hollis
country: United States
facility: Smart Medical Research
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc
state: Ohio
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio LLC
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital of Research
state: Pennsylvania
city: Uniontown
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg, SC
state: South Carolina
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Victoria
country: United States
facility: Victoria Gastroenterology
state: Texas
city: Ogden
country: United States
facility: Care Access Research, Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Gastroenterology Associates
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Buenos Aires
country: Argentina
facility: Cer Instituto Medico
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos José Maria Ramos Mejía
city: Ciudad De Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Cordoba
country: Argentina
facility: Sanatorio Duarte Quiroz
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario De Cordoba
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Clayton
country: Australia
facility: Monash Health
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: South Brisbane
country: Australia
facility: IBD Clinical Trials Mater Research
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Aalst
country: Belgium
facility: Onze -Lieve-Vrouwziekenhuis
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Roeselare
country: Belgium
facility: AZ Delta
city: Botucatu
country: Brazil
facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Curitiba
country: Brazil
facility: CDC - Centro Digestivo de Curitiba
city: Jau
country: Brazil
facility: CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
city: Juiz de Fora
country: Brazil
facility: Galileo Pesquisa Clinica
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Salvador
country: Brazil
facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
city: Santo Andre
country: Brazil
facility: Pesquisare Saude
city: Sao Paulo
country: Brazil
facility: BR TRIALS Ensaios Clinicos e Consultoria Ltda
city: Sao Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: São José Do Rio Preto
country: Brazil
facility: Kaiser Hospta
city: Votuporanga
country: Brazil
facility: INTEGRAL Pesquisa e Ensino
city: Sofia
country: Bulgaria
facility: Medical centre Asklepion
city: Sofia
country: Bulgaria
facility: DCC Convex EOOD
city: Targovishte
country: Bulgaria
facility: Medical Center Leo Clinic EOOD
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Beijing
country: China
facility: China Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing General Hospital
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Lan Zhou
country: China
facility: Lanzhou University Second Hospital
city: Luoyang
country: China
facility: The first affiliated hospital of Henan University of science and technology
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
city: Shi Jia Zhuang Shi
country: China
facility: The Second Hospital of Hebei Medical University
city: Shiyan
country: China
facility: Taihe Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical Hospital
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a s
city: Hradec Kralova
country: Czechia
facility: Gastroenterologie, s.r.o., Hradec Kralove
city: Ostrava
country: Czechia
facility: Artroscan s r o
city: Prague
country: Czechia
facility: AXON Clinical s.r.o.
city: Praha 2
country: Czechia
facility: Synexus Czech s.r.o.
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Besancon Cedex
country: France
facility: CHRU Besancon Hopital Jean Minjoz
city: Le Kremlin Bicêtre
country: France
facility: Hopital de Bicetre
city: Montpellier
country: France
facility: CHRU Montpellier - Hopital Saint-Eloi
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Nîmes
country: France
facility: Polyclinique Du Grand Sud
city: Pessac
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon HCL
city: Reims Cedex
country: France
facility: CHU de Reims
city: Saint Priest en Jarez
country: France
facility: CHU Saint Etienne Hopital Nord
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees BEGIN
city: Toulouse
country: France
facility: CHU Rangueil
city: Vandoeuvre Les nancy
country: France
facility: CHU Nancy Brabois
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum (MVZ) Dachau
city: Duisburg
country: Germany
facility: MVZ Sanaklinikum Duisburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont
city: Gurugram
country: India
facility: Fortis Memorial Research Institute
city: Hyderabad
country: India
facility: Asian Institute Of Gastroenterology
city: Manipal
country: India
facility: Kasturba Medical College Hospital
city: Mumbai
country: India
facility: P D Hinduja National Hospital and Medical Research Center
city: Surat
country: India
facility: SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
city: Afula
country: Israel
facility: Ha'Emek Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center - Jerusalem, ISRAEL
city: Jerusalem
country: Israel
facility: Lev Talpiot Clinic
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Chuo-ku
country: Japan
facility: Ginza central clinic
city: Fujiidera-shi
country: Japan
facility: Sai Gastroenterology Proctology
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hachinohe
country: Japan
facility: Hachinohe City Hospital
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hamamatsu shi
country: Japan
facility: Matsuda Hospital
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kitakyushu
country: Japan
facility: Kyushu Rosai Hospital
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
city: Matsudo
country: Japan
facility: Tokushukai Chiba-Nishi General Hospital
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Nagoya
country: Japan
facility: Yokoyama IBD Clinic
city: Oita
country: Japan
facility: Oita Red Cross Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Okayama
country: Japan
facility: Okayama Saiseikai General Hospital
city: Osaka-Sayama
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Shimotsuga Gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Shinjuku ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Sunto-gun
country: Japan
facility: National Hospital Organization Shizuoka Medical Center
city: Urayasu
country: Japan
facility: Juntendo University Hospital Urayasu
city: Utsunomiya-shi
country: Japan
facility: Kanke Gastrointestinal Clinic
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Amman
country: Jordan
facility: The Speciality Hospital (TSH) / Advanced Clinical Center
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Aydoun
country: Jordan
facility: Irbid Specialty Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chosun university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Suwon si
country: Korea, Republic of
facility: The Catholic university of Korea ST Vincent Hospital
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Chihuahua
country: Mexico
facility: SCIENTIA Investigacion Clinica SC
city: Ciudad de Mexico
country: Mexico
facility: Centro de Investigacion Clinica Acelerada S.C
city: Ciudad de Mexico
country: Mexico
facility: Hospital Médica Sur Tlalpan
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Mexico City
country: Mexico
facility: Clinicos Asociados BOCM, SC
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clínicos Roma S.C.
city: Monterrey
country: Mexico
facility: Fundacion Santos Y De La Garza Evia IBP
city: Saltillo
country: Mexico
facility: Clinical Research Institute Saltillo S.A. de C.V.
city: San Pedro Garza Garcia
country: Mexico
facility: Oncare
city: Boulcott
country: New Zealand
facility: Hutt Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bialystok
country: Poland
facility: Gastromed Kralisz Romatowski Stachurska Sp. j.
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Grudziadz
country: Poland
facility: Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych REUMED Filia nr 2
city: Poznan
country: Poland
facility: EMC Instytut Medyczny SA PL CERTUS
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Bodyclinic Sp. z o.o. sp. k
city: Warszawa
country: Poland
facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Przychodnia Vistamed
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Zamosc
country: Poland
facility: Pro Life Medica Sp z o o ETG Zamosc
city: Banska Bystrica
country: Slovakia
facility: FNsP F.D.R. Banska Bystrica
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Kosice
country: Slovakia
facility: ENDOMED s.r.o
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Villajoyosa
country: Spain
facility: Hosp. de La Marina Baixa
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Istambul
country: Turkey
facility: Istanbul University
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References: