A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.

Study Overview

• Status: Completed
• Conditions: Crohns Disease
• Intervention / Treatment: Drug: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Abiko, Japan, 270-1168
    • KOKIKAI Tokatsu Tsujinaka Hospital
  • Bunkyō City, Japan, 113 8519
    • Institute of Science Tokyo Hospital
  • Hitachi, Japan, 317-0077
    • Hitachi General Hospital
  • Hokkaido, Japan, 078 8510
    • Asahikawa Medical University Hospital
  • Kamakura, Japan, 247-0056
    • Ofuna Chuo Hospital
  • Kishiwada, Japan, 5960042
    • Kishiwada Tokushukai Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Nara, Japan, 635-0022
    • Kenseikai Dongo Hospital
  • Nishinomiya Shi, Japan, 663 8501
    • Hyogo Medical University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Saitama, Japan, 350 8550
    • Saitama Medical Center
  • Sapporo, Japan, 004-0041
    • Sapporo Tokushukai Hospital
  • Sendai Miyagi, Japan, 9810914
    • Sendai Kosei Hospital
  • Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Shinjuku- Ku, Japan, 162-8655
    • National Center for Global Health and Medicine
  • Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Sumida Ku, Japan, 130 8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Toyama, Japan, 9308550
    • Toyama Prefectural Central Hospital
  • Toyohashi, Japan, 441-8570
    • National Hospital Organization Toyohashi Medical Center
  • Ōita, Japan, 870 0823
    • Ishida Clinic of IBD and Gastroenterology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
• Have screening laboratory test results within the protocol specified parameters
• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
• Unstable doses of concomitant Crohn's disease therapy
• Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
• Prior exposure to p40 inhibitors or p19 inhibitors
• Any medical contraindications preventing study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guselkumab; Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.	Drug: Guselkumab; Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.; Other Names: CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported.	From baseline (Week 0) up to Week 48
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (SAE) was 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.	From baseline (Week 0) up to Week 48
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)	Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters	Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters	Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With TEAEs of Infections	Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With TEAEs of Injection-site Reactions	Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With TEAEs Temporally Associated With Infusion	Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent	TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicated greater severity.	From baseline (Week 0) up to Week 48
Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs	Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.	From baseline (Week 0) up to Week 48
Number of Participants With Concomitant Medications for Crohn's Disease	Number of participants with concomitant medications for Crohn's disease were reported.	From screening (Week -8) up to Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Response Through Week 48	Number of participants with clinical response through Week 48 were reported. Clinical response was defined as a greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score less than <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Number of Participants With Clinical Remission Through Week 48	Number of participants with clinical remission through Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48	Number of participants with PRO-2 remission through Week 48 were reported. PRO-2 remission was defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline. Mean daily AP score was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores score at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48	Change from baseline in SES-CD score at Week 48 were reported. The SES-CD score was used to evaluate endoscopic improvement. The SES-CD was based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for the narrowing component which only attain a maximum total score of 11 because, the presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.	Baseline (Week 0) and Week 48
Serum Concentation of Guselkumab	Serum concentration of guselkumab were reported.	Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8
Number of Participants With Anti-Guselkumab Antibodies Through Week 48	Number of participants with anti-guselkumab antibodies through Week 48 were reported.	From Week 0 through Week 48
Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48	Number of participants with neutralizing-guselkumab antibodies through Week 48 were reported.	From Week 0 through Week 48
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration	Change from baseline in inflammatory PD marker of CRP concentration were reported.	Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels	Change from baseline in inflammatory PD marker of FC levels were reported.	Baseline (Week 0), Weeks 4, 8, 12, 24, and 48
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	Change from baseline in CDAI score at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.	At Week 48
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	Number of participants in clinical response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical response was defined as a >=100-point reduction from baseline in CDAI score or CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.	At Week 48
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	Number of participants in clinical remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.	At Week 48
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	Number of participants in endoscopic response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic response was defined as >=50 % improvement from baseline in SES-CD score or SES-CD score less than or equal to (<=) 2. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores across all segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.	At Week 48
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48	Number of participants in endoscopic remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic remission: an SES-CD score <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual subcomponent. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in total score of 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores (all segments) & it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.	At Week 48
Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline	Change from baseline in the average daily P.Eq oral corticosteroid dose (excluding Budesonide) through Week 48 among participants receiving oral corticosteroids other than Budesonide at baseline were reported.	Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	Number of participants not receiving concomitant corticosteroids at Week 48 among participants receiving concomitant corticosteroids at baseline were reported.	At Week 48
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	Number of participants not receiving concomitant corticosteroids for at least 30 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.	Up to Week 48
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline	Number of participants not receiving concomitant corticosteroids for at least 90 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.	Up to Week 48

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.
• Investigators: Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): September 12, 2025

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; guselkumab
• Other Study ID Numbers: CR108801; CNTO1959CRD3003 (Other Identifier: Janssen Research & Development, LLC)

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 and 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
• product manufactured in and exported from the U.S.: Yes