Health TrialsbyHealthPanel

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

ConditionsUlcerative ColitisUlcerative Colitis Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have had an established diagnosis of UC of ≥3 months in duration before baseline.

Have moderately to severely active UC as assessed by the UC disease activity score.

Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).

Are on a stable dose of certain oral UC medications (including corticosteroids).

Disqualifiers

Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.

Have experienced a thrombotic event within 24 weeks before baseline.

Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.

Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eltrekibart

    Drug

    Administered

  • Mirikizumab

    Drug

    Administered

  • Placebo

    Drug

    Administered

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Eltrekibart + PlaceboExperimental treatment 3 interventions
Group B: Mirikizumab + PlaceboExperimental treatment 2 interventions
Group C: Eltrekibart + MirikizumabExperimental treatment 2 interventions
Group D: PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Clinical Remission

Percentage of Participants Achieving Clinical Remission

Time frame
Week 12

Secondary outcomes

1

Percentage of Participants Achieving Clinical Response

Percentage of Participants Achieving Clinical Response

Time frame
Week 12
2

Percentage of Participants Achieving Endoscopic Improvement

Percentage of Participants Achieving Endoscopic Improvement

Time frame
Week 12
3

Percentage of Participants Achieving Endoscopic Remission

Percentage of Participants Achieving Endoscopic Remission

Time frame
Week 12
4

Percentage of Participants Achieving Clinical Remission

Percentage of Participants Achieving Clinical Remission

Time frame
Week 52

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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