Guselkumab with dose increases when needed in adults with Crohn's disease
Tests guselkumab, with higher doses if needed, in adults with Crohn's disease.
Key facts
- Who runs it
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Where
- Amiens Cedex 1, Bayonne, Besançon, Clermont-Ferrand, Clichy, Colmar Cedex, Colombes Cedex, Créteil, Dijon, Grenoble Cedex 9, La Roche Sur Yon Cedex 9, Le Kremlin Bicetre Cedex, Lille Cedex, Marseille, Montpellier Cedex 5, Nantes, Neuilly-Sur-Seine, Nice, Paris, Paris Cedex 12, Paris Cedex 18, Pessac Cedex, Pierre-Bénite, Reims Cedex, Rennes, Roubaix, Saint-Priest-en-Jarez, Toulon, Toulouse Cedex 3, Toulouse Cedex 9, and Vandoeuvre Les Nancy, FranceSee the 31 sites
- Trial code
- Registry title
- Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 210 people, planned
- Started
- 18 Jun 2026
- Expected to end
- 15 Mar 2029
- Type of study
- Interventional
- Treatments tested
- Guselkumab
- Record updated
- 30 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active Crohn's disease who will start guselkumab. It follows them for one year, with the dose raised if needed.
- Age
- 18 to 64 years
- Sex
- All sexes
- Disease stage
- Crohn's disease with active symptoms (abdominal pain > 1 or stool frequency > 3), faecal calprotectin > 250 ug/g, and active disease seen on endoscopy, MRI or ultrasound within 2 months.
- Earlier treatment
- People who have never had an advanced therapy, or have had one or more, can join. Anyone who has had an anti-IL23 drug cannot join.
- Biomarker or test result
- Faecal calprotectin above 250 ug/g.
Main reasons for not taking part
- Earlier treatment with an anti-IL23 drug
- Advanced therapy given together with guselkumab
- Ostomy
- Pregnant or breastfeeding
- Mainly perianal Crohn's disease
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- - 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
Who cannot take part
- Previous exposure to an anti-IL23
- Combination of advanced therapy with GUS,
- Patient with perianal CD predominant disease
- Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis
- - Patient under legal protection,
- Patient with ostomy,
- Pregnant or breastfeeding woman,
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- CHU BesançonBesançon, FranceTaking people
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranceTaking people
- Hopital BeaujonClichy, FranceTaking people
- Centre Hospitalier De ColmarColmar Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisColombes Cedex, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Bicetre HospitalLe Kremlin Bicetre Cedex, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-Seine, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Institut Mutualiste MontsourisParis, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Centre Hospitalier Universitaire De BordeauxPessac Cedex, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- Centre hospitalier de RoubaixRoubaix, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-MerToulon, FranceTaking people
- Clinique PasteurToulouse Cedex 3, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Guselkumab Dose Optimization StrategyTreatment being tested
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.
Treatment: Guselkumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Optimal Care With Guselkumab In Crohn's Disease
- Plain-language title
- Guselkumab with dose increases when needed in adults with Crohn's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07616687, who can take part
- Record updated
- 30 June 2026