A Phase 3 interventional study of Guselkumab and Risankizumab in Crohn Disease, sponsored by Janssen Research & Development, LLC. Recruiting at 164 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 530 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Drug: Guselkumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
Drug: Risankizumab
Guselkumab will be administered.
Also known as: CNTO1959
Risankizumab will be administered.
Number of Participants with Deep Remission at Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Time frame: At Week 52
Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52
Clinical remission is defined as CDAI score \< 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic response is defined as \>50 percent (%) improvement from baseline in the SES CD or SES-CD score \<= 2 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response.
Time frame: At Week 52
Number of Participants with Endoscopic Remission at Week 52
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \> 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Time frame: At Week 52
Number of Participants with Clinical Remission at Week 52
Clinical remission is defined as CDAI score \< 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame: At Week 52
Number of Participants with Steroid-Free Clinical Remission at Week 52
Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score \< 150-point.
Time frame: At Week 52
Number of Participants with Abnormalities in Laboratory Parameters
Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported.
Time frame: Up to Week 148
Number of Participants With Change From Baseline in Laboratory Abnormalities
Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported.
Time frame: Up to week 148
Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to Week 165
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 164 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2028, 30 months after the start.
Of 70 industry-sponsored phase 3 interventional studies under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 69. This study's planned 30 months is below that.
Counting every sponsor, half of 88 studies reached it within 49 months; a quarter within 36 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Guselkumab · Risankizumab
Janssen Research & Development, LLC →