NCT07616687 Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study
| NCT ID | NCT07616687 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-06-18 |
| Primary Completion | 2029-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 210 participants in total. It began in 2026-06-18 with a primary completion date of 2029-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Mathurin Fumery, Investigator
PRINCIPAL INVESTIGATOR
Hospital of Amiens, France
Frequently Asked Questions
Who can join the NCT07616687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07616687 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07616687 currently recruiting?
Yes, NCT07616687 is actively recruiting participants. Contact the research team at mraad@getaid.org for enrollment information.
Where is the NCT07616687 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT07616687 clinical trial?
NCT07616687 is sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. The principal investigator is Mathurin Fumery, Investigator at Hospital of Amiens, France. The trial plans to enroll 210 participants.