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Trial Design
Baseline
Characteristics
Eligibility Criteria
Efficacy
Endpoints
Co-primary endpoints: Clinical remission at week 12 (ELEVATE UC 52 and ELEVATE UC 12) and week 52 (ELEVATE UC 52)2
Primary efficacy analysis was done in patients with a baseline mMS† of 5 to 9 (ELEVATE UC 52: n=409; ELEVATE UC 12: n=334)1,2
ELEVATE UC 52 used a treat through trial design, which may more closely represent real-world practice.2-4
The treat-through trial design of ELEVATE UC 52 may more accurately represent clinical practice2,3
A treat-through trial reflects outcomes for all patients who started therapy, not just those who responded during induction3
Includes non-responders and patients who respond late to treatment, representing real-world practice3,4
ELEVATE UC 52 (N=433) | ELEVATE UC 12 (N=354) | |
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Mean age | 40 years | 40 years |
Gender (female) | 45% | 41% |
Modified Mayo score (mMS) | ||
4 | 6% | 6% |
5-7 (moderate) | 67% | 67% |
>7 (severe) | 28% | 27% |
Biologic/JAK inhibitor (JAKi) exposure | ||
Biologic or JAKi naive | 70% | 67% |
Biologic or JAKi prior exposure | 30% | 33% |
>1 biologic or JAKi exposed | 14% | 18% |
Patients with isolated proctitis | 8% | 8% |
Concomitant treatment for UC at baseline | ||
Oral corticosteroids | 31% | 28% |
Oral aminosalicylates (5-ASAs) | 77% | 83% |
Patients 16 to 80 years of age with moderately to severely active ulcerative colitis (UC)* and a documented history of inadequate response, a loss of response, or an intolerance to ≥1 therapy approved for the treatment of UC†
Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll in both trials, with enrollment capped at 15% of total patients‡
Patients were allowed to receive concomitant treatment for UC before trial screening, provided they were on:
Previous treatment with ≥3 biologics or ≥2 biologics + a JAK inhibitor
A high risk of requiring a colectomy in the next 3 months (per investigator)
A clinically relevant cardiac condition§
ELEVATE UC 52 |
ELEVATE UC 12 |
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Endpoints | Definitions | Week 12 |
Week 52 | Week 12 |
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Primary endpoint |
Clinical remission |
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Key secondary endpoints | Endoscopic improvement |
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Symptomatic remission |
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Histologic-endoscopic mucosal improvement |
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Corticosteroid-free clinical remission |
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N/A | ![]() |
N/A | |
Sustained clinical remission |
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Other prespecified secondary endpoint | Clinical response |
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Read about clinical remission seen in patients on VELSIPITY®.
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