Crohn Disease (CD)Phase 4OPTIMNCT07616687
Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study
A Phase 4 study testing Guselkumab in people with Crohn Disease (CD) and Intensification, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Intensification
- What is being tested?
- Guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2026to 15 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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 join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn Disease (CD), Intensification
- Being tested
- Guselkumab
- Keywords
- Crohn's disease, Intensification, Guselkumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
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 group | Role | What they receive |
|---|---|---|
| Guselkumab Dose Optimization Strategy | Experimental | 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. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at 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.
Measured: 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
Steroid free clinical remission measured by abdominal pain ≤ 1 and stool frequency ≤ 3 with feacal calprotection < 250 ug/g at Week 48
Measured: Week 48 (+/-12Weeks)
Secondary outcomes (10)
- 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),
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
Measured: Week 48
SFCR associated with fecal calprotectin < 250 ug/g at 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
Measured: Week 12, Week 24 and Week 48
Clinical remission at 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
Measured: Week 12, Week 24 and Week 48
Biomarker remission at Week 12, Week 24 and Week 48
Evaluation of the biomarker remission: CRP < 5 g/L and fecal calprotectin <250 ug/g
Measured: Week 12, Week 24 and Week 48,
Need for GUS dose intensification (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.
Measured: Week 12, Week 24 and Week 48
Serum levels of guselkumab (Week 12, Week 24 and Week 48)
Analysis of the serum level of guselkumab
Measured: Week 12, Week 24 and Week 48
Neutralizing antibodies to guselkumab (Week 12, Week 24 and Week 48)
Evaluation of the neutralization antibodies to guselkumab
Measured: Week 12, Week 24 and Week 48
Crohn's Disease-related hospitalization during study period (Week 12, Week 24 and Week 48)
Crohn's Disease-related hospitalization during study period
Measured: 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)
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).
Measured: Week 12, Week 24 and Week 48
Guselkumab persistence
Evaluation of the Guselkumab persistence during the study
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start18 Jun 2026
- Primary completion15 Mar 2029 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will receive subcutaneous guselkumab (GUS) 400 mg every 4 weeks during the induction period at Weeks 0, 4, and 8. At Week 12, treatment response will be assessed based on patient-reported outcomes (PRO2) and fecal calprotectin (FC): * Primary responders, defined as a decrease ≥ 30% in PRO2 and ≥ 25% in FC, will receive GUS 100 mg every 8 weeks as maintenance therapy. * Primary non-responders, defined as the absence of a ≥ 30% decrease in PRO2 or a ≥ 25% decrease in FC at Week 12, will directly receive GUS 200 mg every 4 weeks as maintenance therapy. In case of loss of response for the primary responders between Weeks 12 and 48 defined as an increase in FC \> 25% with a minimum cutoff of 250 µg/g, or an FC value \> 250 µg/g at Week 24, or objective disease activity confirmed by IUS, MRI, treatment will be intensified to GUS 200 mg every 4 weeks. This response-driven treatment strategy explains the need for additional visits during the maintenance period.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathurin Fumery, Investigator, Principal investigator, Hospital of Amiens, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616687
- Sponsor's protocol ID
- GETAID-2025-03
- Other IDs
- 2025-524573-16-00, 2025
- Acronym
- OPTIM
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
PubMed 384378547. Panaccione R, Hart A, Steinwurz F et al. S1052 Efficacy and Safety of Subcutaneous Guselkumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease: Results Through Week 48 From the Phase 3 GRAVITI Study. Am J Gastroenterology 119(10S):p S740-S741, October 2024
6. Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn's disease: results of the GALAXI 2 & 3 phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.
Gordon H, Minozzi S, Kopylov U, Verstockt B, Chaparro M, Buskens C, Warusavitarne J, Agrawal M, Allocca M, Atreya R, Battat R, Bettenworth D, Bislenghi G, Brown SR, Burisch J, Casanova MJ, Czuber-Dochan W, de Groof J, El-Hussuna A, Ellul P, Fidalgo C, Fiorino G, Gisbert JP, Sabino JG, Hanzel J, Holubar S, Iacucci M, Iqbal N, Kapizioni C, Karmiris K, Kobayashi T, Kotze PG, Luglio G, Maaser C, Moran G, Noor N, Papamichael K, Peros G, Reenaers C, Sica G, Sigall-Boneh R, Vavricka SR, Yanai H, Myrelid P, Adamina M, Raine T. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2024 Oct 15;18(10):1531-1555. doi: 10.1093/ecco-jcc/jjae091. No abstract available.
PubMed 38877997Peyrin-Biroulet L, Danese S, Argollo M, Pouillon L, Peppas S, Gonzalez-Lorenzo M, Lytras T, Bonovas S. Loss of Response to Vedolizumab and Ability of Dose Intensification to Restore Response in Patients With Crohn's Disease or Ulcerative Colitis: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2019 Apr;17(5):838-846.e2. doi: 10.1016/j.cgh.2018.06.026. Epub 2018 Jun 20.
PubMed 29935327Singh S, Murad MH, Fumery M, Sedano R, Jairath V, Panaccione R, Sandborn WJ, Ma C. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1002-1014. doi: 10.1016/S2468-1253(21)00312-5. Epub 2021 Oct 22.
PubMed 34688373Feuerstein JD, Ho EY, Shmidt E, Singh H, Falck-Ytter Y, Sultan S, Terdiman JP; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021 Jun;160(7):2496-2508. doi: 10.1053/j.gastro.2021.04.022. No abstract available.
PubMed 34051983
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Care With Guselkumab In Crohn's Disease
- ClinicalTrials.gov ID
- NCT07616687
- Acronym / sponsor ID
- OPTIM / GETAID-2025-03
- Conditions
- Crohn Disease (CD), Intensification
- Keywords
- Crohn's disease, Intensification, Guselkumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will receive subcutaneous guselkumab (GUS) 400 mg every 4 weeks during the induction period at Weeks 0, 4, and 8. At Week 12, treatment response will be assessed based on patient-reported outcomes (PRO2) and fecal calprotectin (FC): * Primary responders, defined as a decrease ≥ 30% in PRO2 and ≥ 25% in FC, will receive GUS 100 mg every 8 weeks as maintenance therapy. * Primary non-responders, defined as the absence of a ≥ 30% decrease in PRO2 or a ≥ 25% decrease in FC at Week 12, will directly receive GUS 200 mg every 4 weeks as maintenance therapy. In case of loss of response for the primary responders between Weeks 12 and 48 defined as an increase in FC > 25% with a minimum cutoff of 250 µg/g, or an FC value > 250 µg/g at Week 24, or objective disease activity confirmed by IUS, MRI, treatment will be intensified to GUS 200 mg every 4 weeks. This response-driven treatment strategy explains the need for additional visits during the maintenance period.
| Arm | Type | Receives |
|---|---|---|
| Guselkumab Dose Optimization Strategy | Experimental | Drug: GuselkumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - 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),
Key exclusion criteria (7 listed)
- - Patient under legal protection,
- Previous exposure to an anti-IL23
- Combination of advanced therapy with GUS,
- Patient with ostomy,
- Pregnant or breastfeeding woman,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabGuselkumab 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. | Drug | Guselkumab Dose Optimization Strategy |
Primary outcome
- 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.
- 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
10 secondary outcomes
- 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
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
Clinical remission at Week 12, Week 24 and Week 48
Time frame: 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,
Need for GUS dose intensification (Week 12, Week 24 and Week 48)
Time frame: 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
Neutralizing antibodies to guselkumab (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)
Time frame: 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
Guselkumab persistence
Time frame: Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 38437854Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1.
- Background7. Panaccione R, Hart A, Steinwurz F et al. S1052 Efficacy and Safety of Subcutaneous Guselkumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease: Results Through Week 48 From the Phase 3 GRAVITI Study. Am J Gastroenterology 119(10S):p S740-S741, October 2024
- Background6. Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn's disease: results of the GALAXI 2 & 3 phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.
- Background: PubMed 38877997Gordon H, Minozzi S, Kopylov U, Verstockt B, Chaparro M, Buskens C, Warusavitarne J, Agrawal M, Allocca M, Atreya R, Battat R, Bettenworth D, Bislenghi G, Brown SR, Burisch J, Casanova MJ, Czuber-Dochan W, de Groof J, El-Hussuna A, Ellul P, Fidalgo C, Fiorino G, Gisbert JP, Sabino JG, Hanzel J, Holubar S, Iacucci M, Iqbal N, Kapizioni C, Karmiris K, Kobayashi T, Kotze PG, Luglio G, Maaser C, Moran G, Noor N, Papamichael K, Peros G, Reenaers C, Sica G, Sigall-Boneh R, Vavricka SR, Yanai H, Myrelid P, Adamina M, Raine T. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2024 Oct 15;18(10):1531-1555. doi: 10.1093/ecco-jcc/jjae091. No abstract available.
- Background: PubMed 29935327Peyrin-Biroulet L, Danese S, Argollo M, Pouillon L, Peppas S, Gonzalez-Lorenzo M, Lytras T, Bonovas S. Loss of Response to Vedolizumab and Ability of Dose Intensification to Restore Response in Patients With Crohn's Disease or Ulcerative Colitis: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2019 Apr;17(5):838-846.e2. doi: 10.1016/j.cgh.2018.06.026. Epub 2018 Jun 20.
- Background: PubMed 34688373Singh S, Murad MH, Fumery M, Sedano R, Jairath V, Panaccione R, Sandborn WJ, Ma C. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1002-1014. doi: 10.1016/S2468-1253(21)00312-5. Epub 2021 Oct 22.
- Background: PubMed 34051983Feuerstein JD, Ho EY, Shmidt E, Singh H, Falck-Ytter Y, Sultan S, Terdiman JP; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021 Jun;160(7):2496-2508. doi: 10.1053/j.gastro.2021.04.022. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease (CD)
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
RecruitingPhase 4
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease
Crohn Disease (CD)
RecruitingPhase 2
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Inflammatory Bowel Diseases, Crohn's Disease
RecruitingPhase 4
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathurin Fumery, Investigator principal investigator
Hospital of Amiens, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guselkumab in people with Crohn Disease (CD) and Intensification, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MIRA RAAD (0033 6 85 29 97 64, mraad@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616687, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.