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LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEli Lilly and Company

About this trial

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).

Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC

Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.

Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization

Are up-to-date on colorectal cancer surveillance per local society guidelines

Disqualifiers

Have a current diagnosis of

Crohn's disease

Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or

primary sclerosing cholangitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4268989

    Drug

    Administered PO

  • Mirikizumab

    Drug

    Administered IV then SC

  • LY4268989 Placebo

    Drug

    Administered PO

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: LY4268989 + MirikizumabExperimental treatment 2 interventions
Group B: Mirikizumab + LY4268989 PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)

The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability

Time frame
Week 12

Secondary outcomes

1

Percentage of Participants Who Achieve Clinical Response with mMS

Time frame
Week 12
2

Percentage of Participants Who Achieve Endoscopic Improvement

Time frame
Week 12
3

Percentage of Participants Who Achieve Symptomatic Remission

Time frame
Week 12
4

Percentage of Participants Who Achieve Clinical Remission with mMS

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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