A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

NCT04469062 — Phase 3, Withdrawn, Eli Lilly and Company

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A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Registry	NCT04469062, acronym LUCENT-ACT
Status	Withdrawn - The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	Eli Lilly and Company (Industry)
Conditions	Ulcerative Colitis
Interventions	Mirikizumab IV, Mirikizumab SC, Vedolizumab IV, Placebo IV, Placebo SC (Drug)
Dates	start 2021-04-20 (estimated), primary completion 2024-03-13 (estimated), completion 2024-06-05 (estimated), first posted 2020-07-13, last updated 2021-05-06

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Mirikizumab	Experimental	Drug: Mirikizumab IV; Drug: Mirikizumab SC	Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Vedolizumab	Active comparator	Drug: Vedolizumab IV	Vedolizumab administered IV.
Placebo	Placebo comparator	Drug: Placebo IV; Drug: Placebo SC	Placebo administered SC and IV.

Mirikizumab IV (Drug), also known as LY3074828: Administered IV
Mirikizumab SC (Drug), also known as LY3074828: Administered SC
Vedolizumab IV (Drug): Administered IV
Placebo IV (Drug): Administered IV
Placebo SC (Drug): Administered SC

+Outcome measures

Primary outcomes

Percentage of Participants in Histologic Remission [Week 12]: Histologic remission based on histology.

Secondary outcomes

Percentage of Participants in Symptomatic Remission [Week 52]: Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
Percentage of Participants in Clinical Remission [Week 52]: Clinical remission based on MMS.
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 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.
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [Baseline, Week 52]: Change from baseline on the IBDQ score.
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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company

+Funding

NIH grants: 2019

My Notes

Public

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