A Phase 3 interventional study of Guselkumab and Guselkumab in Crohn's Disease, sponsored by Janssen Research & Development, LLC. Recruiting at 85 sites in 17 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
Among 13 studies testing guselkumab in Crohn Disease — 6 open to participants now, 11 under way, 7 of them phase 3. guselkumab · Crohn Disease.
Among the 13 studies testing guselkumab in Crohn Disease, this one is the 8th largest by planned enrollment, is one of 3 that started in 2024, is one of 8 in phase 3, reaches primary completion later than 7 of the 10 other live ones, and was the 7th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →6 of the 13 studies testing guselkumab in Crohn Disease are open now, in 12 countries. Each count lists the studies.
guselkumab: first FDA approval 2017 (TREMFYA), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 3 started in 2024.
Median enrollment 196 across the 13 interventional studies. Of the 2 that completed or were terminated, 2 (100%) have results posted.
12 of 13 have an industry lead sponsor. The 5 most frequent:
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.
25 studies in Crohn Disease by Janssen Research & Development, LLC: 7 open now, 11 under way, 8 of them phase 3. Of 12 finished, 7 (58%) have results posted.
Among the 25 studies in Crohn Disease by Janssen Research & Development, LLC, this one is the 14th largest by planned enrollment of the 22 interventional ones, is one of 2 that started in 2024, is one of 11 in phase 3, reaches primary completion later than 5 of the 10 other live ones, and was the 19th registered.
Janssen Research & Development, LLC’s Crohn Disease studies by the year they started, since 2011.
5 of the studies testing guselkumab in Crohn Disease that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT07654751Janssen Research & Development, LLCA Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically | 2027-08-31 |
| NCT07310095Xian-Janssen Pharmaceutical Ltd.A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) | 2027-09-15 |
Among the 13 studies testing guselkumab in Crohn Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Janssen Research & Development, LLC’s 25 in Crohn Disease:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
Drug: Guselkumab
Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
Drug: Guselkumab
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
Drug: Guselkumab
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
Drug: Guselkumab
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
Drug: Guselkumab
Guselkumab will be administered subcutaneously.
Also known as: CNTO1959, TREMFYA
Guselkumab will be administered intravenously.
Also known as: CNTO1959, TREMFYA
Percentage of Participants with Clinical Remission at Week 52
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
Time frame: Week 52
Percentage of Participants with Clinical Response at Week 12
Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Time frame: Week 12
Percentage of Participants with Clinical Response at Week 52
Percentage of participants with clinical response at Week 52 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Time frame: Week 52
Percentage of Participants with Clinical Remission at Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Time frame: Week 12
Percentage of Participants with Endoscopic Remission at Week 52
Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score \<=4 and at least a 2-point reduction from baseline and no subscore \>1.
Time frame: Week 52
Percentage of Participants with Corticosteroid-free Remission at Week 52
Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score \<=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52.
Time frame: Week 52
Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52
Percentage of participants with sustained clinical remission at Weeks 12, 24, and 52 will be assessed. Sustained clinical remission is defined as PCDAI \<=10 at Weeks 12, 24, and 52.
Time frame: Weeks 12, 24, and 52
Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2)
Percentage of participants with clinical remission by PRO-2 will be assessed. Clinical remission by PRO-2 is defined as stool frequency (SF) \<=3 and abdominal pain (AP) \<=1 and no worsening of SF and AP from baseline.
Time frame: Week 12 and/or Week 52
Serum Concentration of Guselkumab During Induction Phase
Serum concentrations of guselkumab will be assessed. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive immunoassay method.
Time frame: From Week 0 to Week 12
Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase
Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration.
Time frame: At Weeks 16, 24, 36, 48 and 52
Change from Baseline in Body Weight at Weeks 12, 24, and 52
Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52
Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52
Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height at Weeks 12, 24, and 52
Change from baseline in height at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height Percentiles at Weeks 12, 24, and 52
Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height z-scores at Weeks 12, 24, and 52
Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height Velocity at Weeks 12, 24, and 52
Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Percentage of Participants with Clinical Remission
Percentage of participants with clinical remission who were assigned to guselkumab dose regimen 1 and did not receive rescue therapy at Week 52 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Response
Percentage of participants who achieve endoscopic response who were assigned to q4w maintenance therapy and did not receive rescue therapy at Week 52 will be assessed. Endoscopic response is defined as \>=50% reduction (global) and \>50% reduction (U.S specific) from SES-CD score at baseline.
Time frame: Week 52
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is 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 64
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 Mar 2024 (actual). Primary completion is estimated for Oct 2027, 43 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 43 months is close to 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 ↗
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Studies of the drug tested here: Guselkumab
Janssen Research & Development, LLC →