Across 100 unique European CTIS inflammatory bowel disease trials authorized in 2024–2026, clinical remission was the dominant endpoint family, appearing in 69/100 trials and as a primary endpoint in 52/100 trials. Endoscopic response or improvement appeared in 53/100 trials, while safety endpoints appeared in 53/100 trials, making the IBD endpoint landscape a remission-plus-endoscopy model with safety as a frequent secondary or early-phase anchor.
Clinical remission appeared in 69/100 trials (69.0%), followed by endoscopic response/improvement and safety/tolerability, each in 53/100 trials (53.0%). Endoscopic remission/healing and symptom or PRO-2 outcomes each appeared in 47/100 trials (47.0%).
European IBD trials are not built around symptom relief alone: 53/100 included endoscopic response or improvement and 47/100 included endoscopic remission or healing, showing that objective mucosal assessment is nearly as central as clinical remission.
Clinical remission was primary in 52/100 trials (52.0%). As secondary endpoints, clinical remission remained common in 49/100 trials (49.0%), but endoscopic remission/healing reached 45/100 (45.0%), symptoms/PRO-2 reached 43/100 (43.0%), and safety endpoints reached 38/100 (38.0%). Exploratory or other endpoints were recorded in 1/100 trial (1.0%).
| Endpoint family | Primary | Secondary | Exploratory / other |
|---|---|---|---|
| Clinical remission | 52.0% | 49.0% | 0.0% |
| Endoscopic response / improvement | 29.0% | 38.0% | 0.0% |
| Symptoms / PRO-2 / urgency | 21.0% | 43.0% | 0.0% |
| Safety / tolerability | 17.0% | 38.0% | 0.0% |
| Endoscopic remission / healing | 4.0% | 45.0% | 0.0% |
| Biomarkers / inflammatory markers | 5.0% | 26.0% | 1.0% |
| Quality of life / fatigue / disability | 0.0% | 33.0% | 1.0% |
The primary endpoint layer is narrower than the secondary layer: 52/100 trials used clinical remission as primary, while secondary endpoints expanded into endoscopic remission/healing in 45/100 trials, symptoms/PRO-2 in 43/100, safety in 38/100, quality of life in 33/100, and biomarkers in 26/100.
The dataset included 49/100 ulcerative colitis trials, 37/100 Crohn’s disease trials, 12/100 mixed UC + Crohn’s or broad IBD trials, and 2/100 broad IBD/other IBD trials. Clinical remission appeared in 35/49 UC trials (71.4%) and 29/37 Crohn’s trials (78.4%), while endoscopic response/improvement appeared in 23/49 UC trials (46.9%) versus 27/37 Crohn’s trials (73.0%).
| Disease group | Trials | Clinical remission | Endoscopic response / improvement | Safety |
|---|---|---|---|---|
| Ulcerative colitis | 49 | 35 / 49 · 71.4% | 23 / 49 · 46.9% | 25 / 49 · 51.0% |
| Crohn’s disease | 37 | 29 / 37 · 78.4% | 27 / 37 · 73.0% | 19 / 37 · 51.4% |
| Mixed UC + Crohn’s / broad IBD | 12 | 5 / 12 · 41.7% | 4 / 12 · 33.3% | 8 / 12 · 66.7% |
| Broad IBD / other IBD | 2 | 0 / 2 · 0.0% | 0 / 2 · 0.0% | 1 / 2 · 50.0% |
Crohn’s disease trials were more endoscopy-forward: 27/37 Crohn’s trials included endoscopic response/improvement versus 23/49 UC trials. UC trials still relied heavily on remission, with clinical remission present in 35/49 and symptom/PRO-2 endpoints present in 26/49.
Phase-specific analysis used 50 Phase II and 56 Phase III CTIS phase memberships. Clinical remission appeared in 31/50 Phase II memberships (62.0%) and 42/56 Phase III memberships (75.0%). Steroid-free remission increased from 3/50 Phase II memberships (6.0%) to 16/56 Phase III memberships (28.6%), while quality of life/fatigue/disability increased from 11/50 (22.0%) to 23/56 (41.1%).
| Endpoint family | Phase II, n=50 | Phase III, n=56 |
|---|---|---|
| Clinical remission | 31 / 50 · 62.0% | 42 / 56 · 75.0% |
| Endoscopic response / improvement | 26 / 50 · 52.0% | 31 / 56 · 55.4% |
| Safety / tolerability | 26 / 50 · 52.0% | 29 / 56 · 51.8% |
| Endoscopic remission / healing | 21 / 50 · 42.0% | 27 / 56 · 48.2% |
| Quality of life / |