Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT07616687
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Crohn Disease (CD)
  • Intensification

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Mar 15, 2029
Completion
Mar 15, 2029

Study Design

Enrollment
210 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab Dose Optimization Strategy
    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.

Primary Outcome Measure

- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48 [ Time Frame: Week 48 +/- 12Weeks for the patients who are intensified between Week 32 and Week 48 ]

Central Contacts

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