NCT04469062

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Typical duration for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

July 10, 2020

Last Update Submit

May 4, 2021

Conditions

Ulcerative Colitis

Keywords

Interleukin-23 (IL-23) antibodyIL-23p19

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants in Histologic Remission

    Histologic remission based on histology.

    Week 12

Secondary Outcomes (9)

  • Percentage of Participants in Symptomatic Remission

    Week 52

  • Percentage of Participants in Clinical Remission

    Week 52

  • Percentage of Participants in Endoscopic Remission

    Week 52

  • Percentage of Participants with Clinical Response

    Week 12

  • Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)

    Week 52

  • +4 more secondary outcomes

Study Arms (3)

Mirikizumab

EXPERIMENTAL

Mirikizumab administered intravenously (IV) and subcutaneously (SC).

Drug: Mirikizumab IVDrug: Mirikizumab SC

Vedolizumab

ACTIVE COMPARATOR

Vedolizumab administered IV.

Drug: Vedolizumab IV

Placebo

PLACEBO COMPARATOR

Placebo administered SC and IV.

Drug: Placebo IVDrug: Placebo SC

Interventions

Mirikizumab IVDRUG

Administered IV

Also known as: LY3074828
Mirikizumab
Mirikizumab SCDRUG

Administered SC

Also known as: LY3074828
Mirikizumab
Vedolizumab IVDRUG

Administered IV

Vedolizumab
Placebo IVDRUG

Administered IV

Placebo
Placebo SCDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 13, 2020

Study Start

April 20, 2021

Primary Completion

March 13, 2024

Study Completion

June 5, 2024

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information