DESTINY II
Sponsor study identifier
Secondary identifiers
OTHER · 2024-A02839-38
interventional
42
1 country
8
Study Start
October 13, 2025
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Crohn's disease (CD) (\> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): \> 40% and \> 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to \> 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2025
Actual (reported)May 15, 2025
Actual (reported)October 13, 2025
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative endoscopic recurrence
Postoperative endoscopic recurrence at 6 months, defined by a Rutgeerts index ≥ i2. This primary endpoint will be defined by endoscopic procedure at 6 months postoperatively.
6 months post-operative
Early dosage of fecal calprotectin at 3 months
Standard dosage of fecal calprotectin at 6 months
An early dosage of faecal calprotectin will be done for the active arm group.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU d'Amiens
Amiens, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Lille
Lille, France
Anthony Buisson
University Hospital, Clermont-Ferrand
First Submitted
May 7, 2025
First Posted
May 15, 2025
Study Start
October 13, 2025
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
HCL
Lyon, France
AP-HM
Marseille, France
CHU de Montpellier
Montpellier, France
Chu de Nice
Nice, France
CHU de Toulouse
Toulouse, France
Study Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 5, 2026
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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