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EfficacyEfficacy Home PageTrial DesignClinical RemissionEarly Symptomatic ResponseEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesMaterialsVideosPrescribing InformationPrescribing Information 
Trial Design

Trial Design

Baseline
Characteristics

Eligibility Criteria

Efficacy
Endpoints

VELSIPITY® was studied across two Phase 3 trials1,2ELEVATE UC 52 and ELEVATE UC 12 were randomised, multicenter, double-blind, placebo-controlled trials in patients 16 to 80 years of age with moderately to severely active UC1,2ELEVATE UC 52 and ELEVATE UC 12 were randomised, multicenter, double-blind, placebo-controlled trials

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

In ELEVATE UC 52, patients whose disease had not improved or had worsened vs baseline (per investigator judgment), could discontinue treatment and, if objective disease worsening criteria were met (having an RB subscore ≥2 or an RB subscore and an SF subscore ≥4 at 2 time points ≥7 and ≤14 days apart), enroll in the OLE. In ELEVATE UC 12, at the end of week 12, patients could enroll in the OLE. In both trials, patients who did not enroll in the OLE entered a 4-week follow-up period, with visits at week 2 and at week 4.2Enrolled patients had a modified Mayo score (mMS) of 4 to 9 with an endoscopy score (ES) ≥2 and a rectal bleeding (RB) subscore ≥1.1OLE=open-label extension; R=randomization; RB=rectal bleeding; SF=stool frequency.

ELEVATE UC 52 used a treat through trial design, which may more closely represent real-world practice.2-4

Learn about a treat-through trial design

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 was the first and only 52-week, phase 3 treat-through trial of an oral advanced therapy§ in UC2
  • In the treat-through trial design for ELEVATE UC 52, patients who did not respond during the 12-week induction period were still included in the week 52 analysis, rather than being ineligible for the maintenance period as in a responder re-randomization trial3
    • This design may more closely reflect clinical practice, as it allows for delayed responses in the maintenance period3
  • In a re-randomisation trial, induction responders are re-randomised for maintenance treatment; therefore, maintenance data only reflect potential outcomes for early responders, which may inflate efficacy data3,4
Based on clinician assessment.2§Advanced therapies include S1P receptor modulators, biologics, and JAK inhibitors.2Caution is advised when comparing clinical trials; head-to-head, randomized trials provide the most reliable comparative efficacy evidence.2R=randomized; RR=re-randomized.
 ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.References:VELSIPITY® (etrasimod) Summary of Product Characteristics. Available online at www.medicines.ie.Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.Atreya R, Neurath MF. The sphingosine-1-phosphate receptor agonist etrasimod in ulcerative colitis. Lancet. 2023;401(10383):1132-1133.Ghosh S, Sandborn WJ, Colombel JF, et al. Interpreting registrational clinical trials of biological therapies in adults with inflammatory bowel diseases. Inflamm Bowel Dis. 2016;22(11):2711-2723.Legal Category S1A
Further information available on request

PP-V1A-0024 Date of preparation February 2025
Baseline Patient Characteristics1-2A majority of patients in the VELSIPITY® phase 3 trials were ideally suited for oral advanced therapy1*
  ELEVATE UC 52 (N=433) ELEVATE UC 12 (N=354)
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%
Scroll left to view table
*Advanced therapies include S1P receptor modulators, biologics, and JAK inhibitors.2†Concomitant UC therapies included stable daily doses of oral aminosalicylates and/or oral corticosteroids (≤20 mg prednisone, ≤9 mg budesonide, or equivalent steroid).1▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.References:
1. 
VELSIPITY® (etrasimod) Summary of Product Characteristics. Available online at medicines.ie.
2. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171.
3. Atreya R, Neurath MF. The sphingosine-1-phosphate receptor agonist etrasimod in ulcerative colitis. Lancet. 2023;401(10383):1132-1133.
4. Sands BE, Cheifetz AS, Nduaka CI, et al. The impact of raising the bar for clinical trials in ulcerative colitis. J Crohns Colitis. 2019;13(9):1217-1226.
Legal Category S1A
Further information available on request

PP-V1A-0024 Date of preparation February 2025
Select inclusion and exclusion criteria for ELEVATE UC 52 and ELEVATE UC 121 Select inclusion criteria:

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:

  • Stable doses of oral 5-ASAs 2 weeks before
  • Stable doses of corticosteroids (prednisone [≤20 mg/day], budesonide [≤9 mg/day], or equivalent) 4 weeks before
    • Investigators were directed to taper corticosteroids in ELEVATE UC 52 after the week 12 assessment
Select exclusion criteria:

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§

A history of opportunistic infections or macular edema Pregnancy or lactation
*In both trials, diagnosis of moderately to severely active UC was confirmed by endoscopy with ≥10 cm rectal involvement and on the basis of an mMS of 4 to 9 with a centrally read endoscopic subscore (ES) ≥2 and a rectal bleeding (RB) subscore ≥1.1Oral 5-ASAs, corticosteroids, thiopurines, JAK inhibitors, and biologics (eg, tumor necrosis factor [TNF] blockers, anti-integrins, and anti–interleukin [IL]-12 and anti–IL-23).2Enrollment of patients with isolated proctitis was capped at 15% of total population.1§A history of myocardial infarction, stroke, or second-degree or third-degree atrioventricular block.15-ASA=aminosalicylate; mMS=modified Mayo score.▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

References:
Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.VELSIPITY® (etrasimod) Summary of Product Characteristics. Available online at www.medicines.ie.
Legal Category S1A
Further information available on request

PP-V1A-0024 Date of preparation February 2025
VELSIPITY® met all primary and key secondary endpoints1,2Trial endpoints were modeled after STRIDE II treatment targets1-3
Scroll left to view table
    ELEVATE
UC 52
ELEVATE 
UC 12
  Endpoints Definitions Week
12
Week 52 Week
12
Primary
endpoint
Clinical remission
  • SF subscore of 0 or 1
  • RB subscore of 0
  • ES ≤1 (excluding friability)
Key secondary endpoints Endoscopic improvement
  • ES ≤1 (excluding friability)
Symptomatic remission
  • SF subscore of 0 (or SF subscore of 1 with a ≥1-point decrease from baseline)
  • RB subscore of 0
Histologic-endoscopic mucosal improvement
  • ES ≤1 (excluding friability)
  • Histologic remission measured by a Geboes Index score <2.0
Corticosteroid-free clinical remission
  • Clinical remission at week 52 in patients who had not received corticosteroids for ≥12 weeks prior to week 52
N/A N/A
Sustained clinical remission
  • Clinical remission at week 12 and at week 52 
Other prespecified secondary endpoint Clinical response
  • ≥2-point and a ≥30% decrease from baseline in mMS
  • ≥1-point decrease from baseline in RB subscore or absolute RB subscore ≤1
  • Primary and key secondary endpoints were controlled for multiplicity via parallel gatekeeping procedures that preserved the type I error rate at 5%1
ES=endoscopic subscore; mMS=modified Mayo score; NA=not applicable; RB=rectal bleeding; STRIDE=Selecting Therapeutic Targets in Inflammatory Bowel Disease.▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.References:Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383): 1159-1171. Supplementary appendix available at: https://www.thelancet.com/cms/10.1016/S0140-6736(23)00061-2/attachment/cdbbc759-490f-4b2a-a3a2-93bc9918b29f/mmc1.pdf. Accessed December 18, 2023.Turner D, Ricciuto A, Lewis A, et al; International Organization for the Study of IBD. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583.Legal Category S1A
Further information available on request

PP-V1A-0024 Date of preparation February 2025
Efficacy Clinical Remission

Read about clinical remission seen in patients on VELSIPITY®.

SEE CLINICAL REMISSION Loading

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