Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study
Phase 4 · Testing Guselkumab · 1 site · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Guselkumab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease (CD) and Intensification.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- \- Patients with a diagnosis of CD according to ECCO guidelines,
- 18 years of age or older at the time of informed consent,
- Absence of contraindication to guselkumab,
Plus 5 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 210 participants are expected to take part.
- Start date: 2026-06-18.
- Main results expected around 2029-03-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- - Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at Week 48 (Week 48 +/- 12Weeks for the patients who are intensified between Week 32 and Week 48)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Intensification |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Enrollment | 210 (estimated) |
| Start date | 2026-06-18 |
| Primary completion (est.) | 2029-03-15 |
| First posted | 2026-06-01 |
| Last updated | 2026-06-30 |
| Official title | Optimal Care With Guselkumab In Crohn's Disease |
| ClinicalTrials.gov ID | NCT07616687 |
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.
Full eligibility criteria (from the record)
Inclusion Criteria: * \- Patients with a diagnosis of CD according to ECCO guidelines, * 18 years of age or older at the time of informed consent, * Absence of contraindication to guselkumab, * Active disease according to PRO2 (abdominal pain > 1 or stool frequency > 3), and faecal calprotectin > 250 ug/g, * Objective active disease documented within ≤ 2 months by endoscopy or by MRI when not contraindicated, orby IUS), * Not currently participating in any interventional research. * Patient naïve or exposed to one or more advanced therapy, in accordance with the approved indication for guselkumab in Crohn's disease. * Females of childbearing potential must have a negative serum pregnancy test at the baseline Visit. Exclusion Criteria: * \- Patient under legal protection, * Previous exposure to an anti-IL23 * Combination of advanced therapy with GUS, * Patient with ostomy, * Pregnant or breastfeeding woman, * Patient with perianal CD predominant disease. * Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie | Amiens | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.