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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 3; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos José Maria Ramos Mejía
  • Buenos Aires, Argentina, B1878DVB
    • CER Instituto Medico
  • Ciudad de Buenos Aires, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Universitario de Córdoba
  • Córdoba, Argentina, X5002AOQ
    • Sanatorio Duarte Quiroz
  • La Plata, Argentina, B1900AXI
    • Hospital Italiano de La Plata
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar Del Plata
  • Rosario, Argentina, S2000KDS
    • Hospital Provincial Del Centenario
• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Camperdown, Australia, 2050
    • Royal Prince Alfred Hospital
  • Clayton, Australia, 3168
    • Monash Health
  • Herston, Australia, 4029
    • Royal Brisbane and Women's Hospital
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Parkville, Australia, 3050
    • Royal Melbourne Hospital
  • South Brisbane, Australia, 4101
    • IBD Clinical Trials Mater Research
  • Woodville South, Australia, 5011
    • The Queen Elizabeth Hospital
  • Woolloongabba, Australia, 4102
    • Princess Alexandra Hospital
• Belgium
  • Aalst, Belgium, 9300
    • Onze -Lieve-Vrouwziekenhuis
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Roeselare, Belgium, 8800
    • AZ DELTA
• Brazil
  • Botucatu, Brazil, 18618-687
    • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  • Brasília, Brazil, 70200-730
    • L2IP Instituto de Pesquisas Clinicas
  • Campinas, Brazil, 13060-904
    • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
  • Curitiba, Brazil, 80430-180
    • CDC - Centro Digestivo de Curitiba
  • Jaú, Brazil, 17201 130
    • CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
  • Juiz de Fora, Brazil, 36033 318
    • Galileo Pesquisa Clinica
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90430-001
    • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
  • Salvador, Brazil, 41500-300
    • CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
  • Santo André, Brazil, 09080-110
    • Pesquisare Saude
  • São José do Rio Preto, Brazil, 15015-110
    • Kaiser Hospta
  • São Paulo, Brazil, 01236030
    • BR TRIALS Ensaios Clinicos e Consultoria Ltda
  • São Paulo, Brazil, 01401-002
    • Instituto D Or de Pesquisa e Ensino IDOR
  • Votuporanga, Brazil, 15500-269
    • Integral Pesquisa e Ensino
• Bulgaria
  • Sofia, Bulgaria, 1680
    • DCC Convex EOOD
  • Sofia, Bulgaria, 1606
    • Medical centre Asklepion
  • Targovishte, Bulgaria, 7700
    • Medical Center Leo Clinic EOOD
• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie GI Associates
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100029
    • China Japan Friendship Hospital
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Chongqing, China, 400014
    • Chongqing General Hospital
  • Ganzhou, China, 341000
    • First Affiliated Hospital of Gannan Medical University
  • Guangzhou, China, 510280
    • ZhuJiang Hospital of Southern Medical University
  • Guangzhou, China, 510260
    • The second Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Hangzhou, China, 310003
    • The First Affiliated Hospital Zhejiang University College of Medicine
  • Hefei, China, 230022
    • The First Affiliated Hospital of Anhui Medical University
  • Jinhua, China, 321009
    • Jinhua Municipal Central Hospital
  • Lanzhou, China, 730030
    • Lanzhou University Second Hospital
  • Luoyang, China, 471003
    • The First Affiliated Hospital of Henan University of Science And Technology
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210009
    • Zhongda Hospital Southeast University
  • Shanghai, China, 200123
    • Shanghai East Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital Shanghai Jiao Tong University
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518101
    • Shenzhen Hospital of Southern Medical University
  • Shijiazhuang, China, 050004
    • The Second Hospital of Hebei Medical University
  • Shiyan, China, 442000
    • Taihe Hospital
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Wuxi, China, 214023
    • Wuxi People s Hospital
  • Yinchuan, China, 750011
    • General Hospital of Ningxia Medical Hospital
  • Zhengzhou, China, 450014
    • The Second Affiliated Hospital of Zhengzhou University
• Czechia
  • Hradec Kralova, Czechia, 500 02
    • Gastroenterologie, s.r.o., Hradec Kralove
  • Ostrava, Czechia, 722 00
    • Artroscan s r o
  • Prague, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Prague, Czechia, 15000
    • Axon Clinical s.r.o.
  • Prague, Czechia, 190 00
    • ISCARE a.s.
  • České Budějovice, Czechia, 37001
    • Nemocnice Ceske Budejovice a s
• France
  • Besançon, France, 25030
    • CHRU Besancon Hopital Jean Minjoz
  • Le Kremlin-Bicêtre, France, 94270
    • Hopital de Bicetre
  • Montpellier, France, 34295 Cedex 5
    • CHRU Montpellier - Hopital Saint-Eloi
  • Neuilly-sur-Seine, France, 92200
    • Clinique Ambroise Paré
  • Nice, France, 06202
    • CHU de Nice Hopital de l Archet
  • Nîmes, France, 30932
    • Polyclinique Du Grand Sud
  • Pessac, France, 33604
    • CHU de Bordeaux - Hospital Haut-Leveque
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon HCL
  • Reims, France, 51092
    • CHU de Reims
  • Saint-Mandé, France, 94160
    • Hôpital d'Instruction des Armées BEGIN
  • Saint-Priest-en-Jarez, France, 42270
    • CHU Saint Etienne Hopital Nord
  • Toulouse, France, 31059
    • Chu Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • CHU Nancy Brabois
• Germany
  • Dachau, Germany, 85221
    • Medizinisches Versorgungszentrum (MVZ) Dachau
  • Duisburg, Germany, 47055
    • MVZ Sanaklinikum Duisburg
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Jerichow, Germany, 39319
    • Praxisgemeinschaft Jerichow
  • Lüneburg, Germany, 21339
    • Staedtisches Klinikum Lueneburg
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvédség Egészségügyi Központ
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem AOK
  • Debrecen, Hungary, 4025
    • Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont
• India
  • Gurugram, India, 122002
    • Fortis Memorial Research Institute
  • Hyderabad, India, 500032
    • Asian Institute of Gastroenterology
  • Manipal, India, 576104
    • Kasturba Medical College Hospital
  • Mumbai, India, 400016
    • P D Hinduja National Hospital and Medical Research Center
  • Surat, India, 395002
    • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
• Israel
  • Afula, Israel, 1834111
    • Ha'Emek Medical Center
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center
  • Holon, Israel, 5822012
    • Wolfson Medical Center
  • Jerusalem, Israel, 93624
    • Lev Talpiot Clinic
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center - Jerusalem, ISRAEL
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
• Japan
  • Bunkyō City, Japan, 113-8510
    • Tokyo Medical and Dental University Hospital
  • Chūōku, Japan, 1040061
    • Ginza central clinic
  • Fujiidera-shi, Japan, 583-0027
    • Sai Gastroenterology Proctology
  • Fukuoka, Japan, 814 0180
    • Fukuoka University Hospital
  • Fukushima, Japan, 960 1295
    • Fukushima Medical University Hospital
  • Hachinohe, Japan, 031-8555
    • Hachinohe City Hospital
  • Hachiōji, Japan, 192-0032
    • Tokai University Hachioji Hospital
  • Hamamatsu, Japan, 432-8061
    • Matsuda Hospital
  • Higashiibaraki-gun, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kagoshima, Japan, 892-0843
    • Kagoshima IBD Gastroenterology Clinic
  • Kanazawa, Japan, 920-8650
    • National Hospital Organization Kanazawa Medical Center
  • Kashiwa, Japan, 277-0871
    • Tsujinaka Hospital Kashiwanoha
  • Kitakyushu, Japan, 800-0296
    • Kyushu Rosai Hospital
  • Kumagaya-shi, Japan, 360-8567
    • Kumagaya General Hospital
  • Kure, Japan, 737-0023
    • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • Matsudo, Japan, 270-2251
    • Tokushukai Chiba-Nishi General Hospital
  • Matsumoto, Japan, 399-8701
    • National Hospital Organization Matsumoto Medical Center
  • Nagoya, Japan, 460-0022
    • Yokoyama IBD Clinic
  • Okayama, Japan, 700-0013
    • Okayama Saiseikai General Hospital
  • Osaka, Japan, 530-0011
    • Kinshukai Infusion Clinic
  • Osaka, Japan, 543 8555
    • Japanese Red Cross Osaka Hospital
  • Shimotsuga Gun, Japan, 321 0293
    • Dokkyo Medical University Hospital
  • Shinjuku Ku, Japan, 162 8655
    • Center Hospital of the National Center for Global Health and Medicine
  • Sumida Ku, Japan, 130 8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Sunto-gun, Japan, 411-8611
    • National Hospital Organization Shizuoka Medical Center
  • Urayasu, Japan, 279-0021
    • Juntendo University Hospital Urayasu
  • Utsunomiya, Japan, 320-0003
    • Kanke Gastrointestinal Clinic
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
  • Ōita, Japan, 870-0033
    • Oita Red Cross Hospital
  • Ōita, Japan, 870-0823
    • Ishida Clinic of IBD and Gastroenterology
  • Ōsaka-sayama, Japan, 589-8511
    • Kindai University Hospital
• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital
  • Amman, Jordan, 11194
    • The Speciality Hospital (TSH) / Advanced Clinical Center
  • Aydoun, Jordan, 21166
    • Irbid Specialty Hospital
  • Irbid, Jordan, 22110
    • King Abdullah University Hospital
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • George Town, Malaysia, 10990
    • Hospital Pulau Pinang
  • Johor Bahru, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Seremban, Malaysia, 70300
    • Hospital Tuanku Jaafar
• Mexico
  • Chihuahua City, Mexico, 31207
    • SCIENTIA Investigacion Clinica SC
  • Guadalajara, Mexico, 44650
    • Clinica de Investigacion en Reumatologia y Obesidad
  • Mexico City, Mexico, 03300
    • Clinicos Asociados BOCM, SC
  • Mexico City, Mexico, 14050
    • Hospital Médica Sur Tlalpan
  • Mexico City, Mexico, 07369
    • Centro de Investigacion Clinica Acelerada S.C
  • Monterrey, Mexico, 64610
    • Centro Regiomontano de Estudios Clínicos Roma S.C.
  • Monterrey, Mexico, 64710
    • Fundacion Santos Y De La Garza Evia IBP
  • Mérida, Mexico, 97070
    • Medical Care & Research SA de CV
  • Saltillo, Mexico, 25020
    • Clinical Research Institute Saltillo S.A. de C.V.
  • San Pedro Garza García, Mexico, 66220
    • Oncare
• New Zealand
  • Boulcott, New Zealand, 5010
    • Hutt Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Grafton, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
• Poland
  • Bialystok, Poland, 15-322
    • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
  • Chojnice, Poland, 89 600
    • Centrum Medyczne Lukamed Sp z o o
  • Chojnice, Poland, 89 600
    • Centrum Medyczne Lukamed Sp z o o 1
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Krakow, Poland, 30 363
    • Centrum Medyczne Plejady
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych REUMED Filia nr 2
  • Poznan, Poland, 60 309
    • EMC Instytut Medyczny SA PL CERTUS
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne Medyk
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Torun, Poland, 87 100
    • GASTROMED Sp. z o.o.
  • Warsaw, Poland, 03 712
    • Bodyclinic Sp. z o.o. sp. k
  • Warsaw, Poland, 04 501
    • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
  • Wroclaw, Poland, 53 149
    • Przychodnia Vistamed
  • Wroclaw, Poland, 53 611
    • Melita Medical Sp. z o.o.
  • Zamość, Poland, 22-400
    • Pro Life Medica Sp z o o ETG Zamosc
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • FNsP F.D.R. Banska Bystrica
  • Bratislava, Slovakia, 811 09
    • Cliniq s.r.o.
  • Košice, Slovakia, 040 13
    • ENDOMED s.r.o
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Hospital
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Gwangju, South Korea, 61453
    • Chosun University Hospital
  • Gyeonggi-do, South Korea, 15355
    • Korea University Ansan Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital
  • Seoul, South Korea, 130 050
    • Kyung Hee University Hospital
  • Suwon, South Korea, 16247
    • The Catholic University of Korea, St. Vincent's Hospital
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Villajoyosa, Spain, 03570
    • Hosp. de La Marina Baixa
  • Zaragoza, Spain, 50009
    • Hosp. Univ. Miguel Servet
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University
  • Izmir, Turkey (Türkiye), 35040
    • Ege University Medical Faculty
  • Mersin, Turkey (Türkiye), 33343
    • Mersin University Medical Faculty
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona
  • California
    • Apple Valley, California, United States, 92307
      • Om Research LLC 1
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Florida
    • Clearwater, Florida, United States, 33762
      • Gastro Florida
    • Kissimmee, Florida, United States, 34741
      • I.H.S. Health. LLC
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services LLC
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC
    • Orlando, Florida, United States, 32806
      • Orlando Health
    • Temple Terrace, Florida, United States, 34209
      • Theia Clincial Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of Georgia, P.C
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central GA
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Health Center
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center
  • New York
    • Hollis, New York, United States, 11423
      • Smart Medical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • University of North Carolina
    • High Point, North Carolina, United States, 27260
      • Peters Medical Research
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
    • Westlake, Ohio, United States, 44145
      • Gastro Intestinal Research Institute of Northern Ohio LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny General Hospital of Research
    • Uniontown, Pennsylvania, United States, 15401
      • Frontier Clinical Research
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Gastroenterology Associates of Orangeburg, SC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • San Antonio, Texas, United States, 78229
      • UT Health Science Center at San Antonio
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
    • Victoria, Texas, United States, 77407
      • Victoria Gastroenterology
  • Utah
    • Ogden, Utah, United States, 84403
      • Care Access Research, Ogden
    • Salt Lake City, Utah, United States, 84124
      • Gastroenterology Associates
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Guselkumab; Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.	Drug: Guselkumab Dose 1; Guselkumab (Dose 1) will be administered as SC injection.; Drug: Guselkumab Dose 2; Guselkumab (Dose 2) will be administered as SC injection.
Experimental: Group 2: Guselkumab; Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.	Drug: Guselkumab Dose 1; Guselkumab (Dose 1) will be administered as SC injection.; Drug: Guselkumab Dose 3; Guselkumab (Dose 3) will be administered as SC injection.
Placebo Comparator: Group 3: Placebo; Participants will receive matching placebo SC injection.	Other: Placebo; Placebo will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission at Week 12	Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Symptomatic Remission at Week 12	Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.	Week 12
Percentage of Participants With Endoscopic Improvement at Week 12	Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.	Week 12
Percentage of Participants in Clinical Response at Week 12	Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.	Week 12
Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12	Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.	Week 12
Percentage of Participants in Clinical Remission at Week 24	Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.	Week 24
Percentage of Participants in Symptomatic Remission at Week 24	Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.	Week 24
Percentage of Participants With Endoscopic Improvement at Week 24	Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.	Week 24
Percentage of Participants in Clinical Response at Week 24	Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by >= 30% and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.	Week 24

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Long M, Allegretti JR, Danese S, Germinaro M, Baker T, Alvarez Y, Kavalam M, Han C, Jorgens S, Jiang L, Zhang H, Hisamatsu T, Rubin DT, Peyrin-Biroulet L; ASTRO Study Group. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Apr;11(4):284-298. doi: 10.1016/S2468-1253(25)00322-X. Epub 2026 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): April 2, 2024
• Study Completion (Estimated): October 6, 2028

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colitis, Ulcerative; Guselkumab
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CR109228; 2022-000365-41 (EudraCT Number); CNTO1959UCO3004 (Other Identifier: Janssen Research & Development, LLC); 2023-504719-34-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No