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

May 27, 2026 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Optimal Care With Guselkumab In Crohn's Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

  • To evaluate the effectiveness of GUS intensification from 100 mg q8w to 200 mg q4w in patients with loss of response,
  • To evaluate the effectiveness of an intensified GUS 200 mg q4w maintenance therapy in patients who are primary non-responders to GUS SC induction at 12 weeks;
  • To assess the factors associated with GUS intensification effectiveness.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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
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.
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
Time Frame: Week 48 (+/-12Weeks)
Steroid free clinical remission measured by abdominal pain ≤ 1 and stool frequency ≤ 3 with feacal calprotection < 250 ug/g at Week 48
Week 48 (+/-12Weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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),
Time Frame: Week 48
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
Week 48
SFCR associated with fecal calprotectin < 250 ug/g at Week 12, Week 24 and Week 48,
Time Frame: 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
Week 12, Week 24 and Week 48
Clinical remission at Week 12, Week 24 and Week 48
Time Frame: 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
Week 12, Week 24 and Week 48
Biomarker remission at Week 12, Week 24 and Week 48
Time Frame: Week 12, Week 24 and Week 48,
Evaluation of the biomarker remission: CRP < 5 g/L and fecal calprotectin <250 ug/g
Week 12, Week 24 and Week 48,
Need for GUS dose intensification (Week 12, Week 24 and Week 48)
Time Frame: 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.
Week 12, Week 24 and Week 48
Serum levels of guselkumab (Week 12, Week 24 and Week 48)
Time Frame: Week 12, Week 24 and Week 48
Analysis of the serum level of guselkumab
Week 12, Week 24 and Week 48
Neutralizing antibodies to guselkumab (Week 12, Week 24 and Week 48)
Time Frame: Week 12, Week 24 and Week 48
Evaluation of the neutralization antibodies to guselkumab
Week 12, Week 24 and Week 48
Crohn's Disease-related hospitalization during study period (Week 12, Week 24 and Week 48)
Time Frame: Week 12, Week 24 and Week 48
Crohn's Disease-related hospitalization during study period
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)
Time Frame: 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).
Week 12, Week 24 and Week 48
Guselkumab persistence
Time Frame: Week 48
Evaluation of the Guselkumab persistence during the study
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Mathurin Fumery, Investigator, Hospital of Amiens, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 15, 2029

Study Completion (Estimated)

March 15, 2029

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID-2025-03
  • 2025-524573-16-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease (CD)

Clinical Trials on Guselkumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe