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

Ulcerative Colitis Clinical Trial

— LUCENT-ACT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04469062
• Other study ID #: 16825
• Secondary ID: I6T-MC-AMBI2019-
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 20, 2021
• Est. completion date: June 5, 2024

Study information

• Verified date: May 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 5, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mirikizumab IV
Administered IV
• Mirikizumab SC
Administered SC
• Vedolizumab IV
Administered IV
• Placebo IV
Administered IV
• Placebo SC
Administered SC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Histologic Remission	Histologic remission based on histology.	Week 12
Secondary	Percentage of Participants in Symptomatic Remission	Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.	Week 52
Secondary	Percentage of Participants in Clinical Remission	Clinical remission based on MMS.	Week 52
Secondary	Percentage of Participants in Endoscopic Remission	Endoscopic remission based on MMS ES.	Week 52
Secondary	Percentage of Participants with Clinical Response	Clinical response based on MMS.	Week 12
Secondary	Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)	CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.	Week 52
Secondary	Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline	Percentage of participants with resolution of EIMs among those that had them at baseline.	Week 52
Secondary	Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score	Change from baseline on the IBDQ score.	Baseline, Week 52
Secondary	Percentage of Participants Undergoing Surgery for UC (Including Colectomy)	Percentage of participants undergoing surgery for UC (including colectomy).	Week 52
Secondary	Percentage of Participants Hospitalized for UC	Percentage of participants hospitalized for UC.	Week 52

External Links

•   A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)