Ulcerative Colitis
Conditions
Keywords
Interleukin-23 (IL-23) antibody, IL-23p19
Brief summary
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
Interventions
DRUGMirikizumab IV
Administered IV
DRUGMirikizumab SC
Administered SC
DRUGVedolizumab IV
Administered IV
DRUGPlacebo IV
Administered IV
DRUGPlacebo SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a diagnosis of UC for at least 3 months prior to baseline * Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS) * Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC * Participants must, if female, meet the contraception requirements
Exclusion criteria
* Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) * Participants must not have had a previous colectomy * Participants must not have current evidence of toxic megacolon * Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab * Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Histologic Remission | Week 12 | Histologic remission based on histology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Undergoing Surgery for UC (Including Colectomy) | Week 52 | Percentage of participants undergoing surgery for UC (including colectomy). |
| Percentage of Participants Hospitalized for UC | Week 52 | Percentage of participants hospitalized for UC. |
| Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline | Week 52 | Percentage of participants with resolution of EIMs among those that had them at baseline. |
| Percentage of Participants in Symptomatic Remission | Week 52 | Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores. |
| Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score | Baseline, Week 52 | Change from baseline on the IBDQ score. |
| Percentage of Participants in Endoscopic Remission | Week 52 | Endoscopic remission based on MMS ES. |
| Percentage of Participants with Clinical Response | Week 12 | Clinical response based on MMS. |
| Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline) | Week 52 | CS free remission without surgery based on clinical remission, symptomatic remission and no CS use. |
| Percentage of Participants in Clinical Remission | Week 52 | Clinical remission based on MMS. |
Outcome results
None listed