LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

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

About this trial

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.

The study will last up to approximately 108 weeks, excluding screening.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC

Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1

Have evidence of UC extending proximal to the rectum

Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years

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 orally

  • Placebo

    Drug

    Administered orally

Treatment groups

1,431 Participants
are divided into 3 treatment groups
Group A: LY4268989 Study Dose 1Experimental treatment 1 intervention
Group B: LY4268989 Study Dose 2Experimental treatment 1 intervention
Group C: Placebo Study DosePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Week 10
2

Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10

Time frame
Week 52

Secondary outcomes

1

Percentage of Participants Who Achieve Clinical Response with mMS

Time frame
Week 10
2

Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10

Time frame
Week 10 Up to Week 52
3

Percentage of Participants Who Achieve Symptomatic Response

Time frame
Baseline Up to Week 8
4

Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10

Time frame
Week 10 Up to Week 52

Other outcomes

Sponsors and contacts

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