A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Registration Number
- NCT05528510
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 418
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Guselkumab Guselkumab Dose 1 Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection. Group 1: Guselkumab Guselkumab Dose 2 Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection. Group 2: Guselkumab Guselkumab Dose 1 Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection. Group 2: Guselkumab Guselkumab Dose 3 Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection. Group 3: Placebo Placebo Participants will receive matching placebo SC injection.
- Primary Outcome Measures
Name Time Method Clinical Remission Week 12 Clinical remission per modified Mayo score.
- Secondary Outcome Measures
Name Time Method Clinical Response Weeks 12 and 24 Clinical response per modified Mayo score.
Clinical Remission Week 24 Clinical remission per modified Mayo score.
Symptomatic Remission Weeks 12 and 24 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).
Endoscopic Improvement Weeks 12 and 24 Endoscopic improvement per Mayo endoscopy subscore.
Histologic-Endoscopic Mucosal Improvement Week 12 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).
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention Up to Week 268 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.
Trial Locations
- Locations (235)
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
Kinshukai Infusion Clinic
🇯🇵Osaka, Japan
Hospital Umum Sarawak
🇲🇾Kuching, Malaysia
Hospital Tuanku Jaafar
🇲🇾Seremban, Malaysia
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
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 Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.
🇵🇱Grudziadz, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Centrum Medyczne Promed
🇵🇱Krakow, Poland
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, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Istanbul University
🇹🇷Istambul, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, 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
🇦🇷Cordoba, Argentina
Hospital Privado Universitario De Cordoba
🇦🇷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, 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
🇧🇷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
BR TRIALS Ensaios Clinicos e Consultoria Ltda
🇧🇷Sao Paulo, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
🇧🇷Sao Paulo, Brazil
Kaiser Hospta
🇧🇷São José Do Rio Preto, 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
🇨🇳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, China
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, Czechia
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
CHU Saint Etienne Hopital Nord
🇫🇷Saint Priest en Jarez, France
Hopital d'Instruction des Armees BEGIN
🇫🇷Saint-Mande, France
CHU Rangueil
🇫🇷Toulouse, France
CHU Nancy Brabois
🇫🇷Vandoeuvre Les nancy, France
Medizinisches Versorgungszentrum (MVZ) Dachau
🇩🇪Dachau, Germany
MVZ Sanaklinikum Duisburg
🇩🇪Duisburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Praxisgemeinschaft Jerichow
🇩🇪Jerichow, Germany
Staedtisches Klinikum Lueneburg
🇩🇪Lueneburg, 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
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku, Japan
Ginza central clinic
🇯🇵Chuo-ku, 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
🇯🇵Hachioji, Japan
Matsuda Hospital
🇯🇵Hamamatsu shi, 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
Oita Red Cross Hospital
🇯🇵Oita, Japan
Ishida Clinic of IBD and Gastroenterology
🇯🇵Oita, Japan
Okayama Saiseikai General Hospital
🇯🇵Okayama, Japan
Kindai University Hospital
🇯🇵Osaka-Sayama, Japan
Japanese Red Cross Osaka Hospital
🇯🇵Osaka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga Gun, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida ku, Japan
National Hospital Organization Shizuoka Medical Center
🇯🇵Sunto-gun, Japan
Center Hospital of the 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, 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
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
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
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic university of Korea ST Vincent Hospital
🇰🇷Suwon si, Korea, Republic of
Hospital Selayang
🇲🇾Batu Caves, Malaysia
Hospital Pulau Pinang
🇲🇾George Town, Malaysia
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Malaysia
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, Mexico
Hutt Hospital
🇳🇿Boulcott, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
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
Przychodnia Vistamed
🇵🇱Wroclaw, Poland
Melita Medical Sp. z o.o.
🇵🇱Wroclaw, Poland
Pro Life Medica Sp z o o ETG Zamosc
🇵🇱Zamosc, Poland
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, Slovakia
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan