Inflamatory bowel Ulcerative Colitis
Conditions
Interventions
This study involves a comparison of IV administration of mirikizumab versus
placebo during a 12-week induction period. Mirikizumab or Placebo is given as
an intravenous infusion (Weeks 0, 4, 8).
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients *18 and *80 years of age at the time of initial screening 2. Diagnosis of UC for at least 3 months prior to baseline. 3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). 4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. 5. If female, must meet the contraception requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis). 2. Patients with a previous colectomy. 3. Patients with current evidence of toxic megacolon. 4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti- IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is clinical remission at Week 12 (mirikizumab versus placebo). Clinical remission is based on the MMS and is defined in protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| The MMS and the composite SF and RB score, derived from assessment of the Mayo score, will be used to determine the major secondary endpoints. The major secondary endpoints are as follows: - Clinical response at Week 12. - Endoscopic remission at Week 12. - Symptomatic remission at Week 4. - Symptomatic remission at Week 12. - Clinical response at Week 12 in the biologic-failed population | — |
Countries
Netherlands
Outcome results
None listed