A Phase 4 interventional study of Guselkumab in Crohn Disease (CD) and Intensification, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Phase 4, Interventional, and Treatment
Crohn's disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterized by phases of relapse and remission. Tumor necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12/23 are the main therapeutic agents to obtain deep remission and prevent disability. Despite the significant advances these biologics represent in treating inflammatory bowel disease (IBD), many patients experience suboptimal responses, including primary non-response or a loss of effectiveness over time, often leading to treatment discontinuation. For all these medications, a dose-response relationship has been demonstrated and an increase in dose or dosing frequency is recommended. Dose escalation is now an essential therapeutic approach necessary in 30 to 50% of CD patients treated with biologics. This strategy, supported by international guidelines, allows for long-term efficacy to be maintained without compromising safety.
Guselkumab (GUS) is a monoclonal antibody targeting the p19 subunit of IL-23. In a recent phase III trial (GALAXI), GUS demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo and ustekinumab. In the GALAXI phase III program, at least 30% of patients did not achieve clinical response after a 12-week intravenous induction, and almost 20% experienced a loss of response by week 44. In these patients, the benefit of an intensified dose of GUS (200 mg q4w) maintenance remains to be determined to guide clinicians in optimizing its use in clinical practice. The investigator aimed to evaluate the one-year effectiveness of GUS in CD in real-world settings and under optimal conditions allowing dose intensification.
Interventionnel, open multicenter study, the objectives are:
Primary Objective To evaluate the one-year effectiveness of GUS in CD in real-world setting.
Secondary Objectives
Exclusion Criteria:
Participants with active Crohn disease receive guselkumab treatment as part of a treat-to-target strategy. During maintenance therapy, dose optimization may be performed according to clinical response criteria defined in the protocol.
Drug: Guselkumab
Guselkumab is a human monoclonal antibody targeting IL-23. In this study, patients receive guselkumab as part of a treat-to-target strategy. At week 12 (W12), patients are managed according to disease response: those with adequate response continue standard maintenance dosing, while non-responders are escalated to an intensified treatment regimen with adjusted dosing frequency.
- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48
Steroid-free clinical remission (SFCR), defined as clinical remission measured by the patient reprt outcome, PRO2 : abdominal pain ≤ 1 and stool frequency ≤ 3, without corticosteroid use at the time of assessment, combined with fecal calprotectin \< 250 µg/g.
Time frame: Week 48 +/- 12Weeks for the patients who are intensified between Week 32 and Week 48
- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48
Steroid free clinical remission measured by abdominal pain ≤ 1 and stool frequency ≤ 3 with feacal calprotection \< 250 ug/g at Week 48
Time frame: Week 48 (+/-12Weeks)
- Morphological remission at Week 48 assessed using the same tool that was used for the patient's inclusion: endoscopy, MRI or IUS (major secondary endpoint),
Evaluation of the morphological remission at W48 by one of the morphological exams: endoscopy: SES-CD \<3 points, MRI: bowel wall thickness ≤3 mm without contrast enhancement, IUS: bowel wall thickness ≤3 mm without color doppler signal
Time frame: Week 48
SFCR associated with fecal calprotectin < 250 ug/g at Week 12, Week 24 and Week 48,
Evaluation of the clinical remission by PRO2: abdominal pain ≤ 1 and stool frequency ≤ 3, without corticoids associates with a biological remission defined by calprotectin \< 250 ug/g
Time frame: Week 12, Week 24 and Week 48
Clinical remission at Week 12, Week 24 and Week 48
Evaluation of the Clinical remission at the visits by the patient report outcome PRO2: abdominal pain ≤ 1 and stool frequency ≤ 3
Time frame: Week 12, Week 24 and Week 48
Biomarker remission at Week 12, Week 24 and Week 48
Evaluation of the biomarker remission: CRP \< 5 g/L and fecal calprotectin \<250 ug/g
Time frame: Week 12, Week 24 and Week 48,
Need for GUS dose intensification (Week 12, Week 24 and Week 48)
Evaluation of the need of intensification at the visits if the FC increase (\> 25% with a minimal cut-off of 250 ug/g) between W12 and W48 or by a FC \> 250 µg/g at W24, or disease activity confirmed by : Endoscopy: SES-CD \> 3 points or IUS: bowel wall thickness ≥ 3 mm and/or with color doppler signal, or MRI : bowel wall thickness ≥3 mm and/or with contrast enhancement.
Time frame: Week 12, Week 24 and Week 48
Serum levels of guselkumab (Week 12, Week 24 and Week 48)
Analysis of the serum level of guselkumab
Time frame: Week 12, Week 24 and Week 48
Neutralizing antibodies to guselkumab (Week 12, Week 24 and Week 48)
Evaluation of the neutralization antibodies to guselkumab
Time frame: Week 12, Week 24 and Week 48
Crohn's Disease-related hospitalization during study period (Week 12, Week 24 and Week 48)
Crohn's Disease-related hospitalization during study period
Time frame: Week 12, Week 24 and Week 48
-Change in the Short Inflammatory Bowel Disease Questionnaire(SIBD-Q) from baseline (Week 12, Week 24 and Week 48)
Analysis of the change in SIBD-Q (quality of life index) during the study Score range: 10 - 70 The higher the score, the better the patient's clinical status (i.e., greater likelihood of remission).
Time frame: Week 12, Week 24 and Week 48
Guselkumab persistence
Evaluation of the Guselkumab persistence during the study
Time frame: Week 48
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives