Ulcerative Colitis · Ulcerative Colitis Chronic
Phase 2 Study of Eltrekibart and Mirikizumab for Active Ulcerative Colitis
This Phase 2 study is examining the safety and efficacy of eltrekibart and mirikizumab, given alone or together, in adults with moderately to severely active ulcerative colitis.
Registry title: A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
46 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Eltrekibart or Mirikizumab
- Design
- Randomized · Double
- Central study contact
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559LillyTrials@Lilly.com
- Sponsor
- Eli Lilly and Company
Research question
What are the safety and efficacy of eltrekibart and mirikizumab, used alone or together, for adults with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study is looking for people diagnosed with ulcerative colitis at least three months before baseline.
- The study is looking for people whose ulcerative colitis is moderately to severely active according to the study's disease activity score.
- The study is looking for people who did not respond adequately, lost response, or could not tolerate at least one specified conventional medication or advanced therapy.
Participation overview
What participation may involve
Participants undergo screening and are randomized to a regimen involving eltrekibart, mirikizumab, their combination, or placebo. The registry states that each participant's total trial duration is about 69 weeks, including screening. What participation may involve: - Complete screening within 35 days before enrollment. - Receive an assigned regimen involving eltrekibart, mirikizumab, their combination, or placebo. - Complete assessments of clinical remission and response, including assessments reported at Weeks 12 and 52. - Complete endoscopic, histologic-endoscopic, quality-of-life, and drug-concentration assessments described as study outcomes. The registry reports about 69 weeks of participation per person, including screening; the entire study is expected to last approximately four to five years.
Study interventions
What participants may receive or do
- Eltrekibart: Eltrekibart, also identified as LY3041658, is administered either with mirikizumab or in an arm that also includes placebo.
- Mirikizumab: Mirikizumab, also identified as LY3074828, is administered alone, with eltrekibart, or in study arms that include placebo.
- Placebo: A placebo is administered in three listed study arms, but the registry's arm descriptions do not clearly specify every treatment sequence or the chance of receiving placebo.
Study design
How the comparison works
This is a randomized, parallel-group Phase 2 treatment study comparing regimens involving eltrekibart, mirikizumab, their combination, and placebo. Participants are assigned to parallel study groups by randomization. The study is double-blind: both participants and investigators are masked to treatment assignment. The listed groups use placebo and separate-drug regimens to compare eltrekibart, mirikizumab, and their combination, although some arm descriptions are ambiguous. Placebo is included in three listed arm groups; the registry does not state an individual's probability of receiving it.
Reported activities
Procedures and tests
- Screening is required within 35 days before enrollment.
- Ulcerative colitis activity is assessed using the study's UC disease activity score.
- Clinical remission is assessed at Week 12 and Week 52.
- Clinical response is assessed at Week 12.
- Endoscopic improvement and endoscopic remission are assessed at Week 12.
- Histologic-endoscopic mucosal improvement is assessed at Week 12.
- The Inflammatory Bowel Disease Questionnaire is assessed at baseline and Week 12.
- Steady-state trough concentrations of eltrekibart and mirikizumab are measured at Week 12.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- An established ulcerative colitis diagnosis must have been present for at least three months before baseline.
- Ulcerative colitis must be moderately to severely active according to the study's disease activity score.
- A person must have had an inadequate response, lost response, or intolerance to at least one conventional medication or one advanced therapy listed by the registry.
- Certain oral ulcerative colitis medications, including corticosteroids, must be taken at a stable dose.
- Participants must meet the study's contraception requirements.
Possible reasons someone may not be able to join
- Prior treatment with an anti-interleukin-23p19 or anti-interleukin-12p40 antibody is not allowed.
- A thrombotic event within 24 weeks before baseline is exclusionary.
- A current diagnosis of Crohn's disease or certain other inflammatory gastrointestinal diseases is exclusionary.
- Certain abdominal surgery within the previous three months, or likely need for ulcerative colitis surgery during the study, is exclusionary.
- A history of certain adenomas, dysplasia, or malignancies is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not state how many visits are required, how often they occur, or which visits must be in person.
- Placebo appears in three listed groups, but the registry does not report the allocation ratios or an individual's chance of receiving placebo.
- The registry requires stable doses of certain oral ulcerative colitis medications but does not identify all permitted medications, doses, or whether they continue throughout the trial.
- The registry does not provide washout periods for prior or current therapies.
- The registry does not describe rescue treatment if ulcerative colitis worsens during the study.
- Endoscopic outcomes are listed, but the registry does not state the exact number, timing, preparation, sedation, or biopsy requirements for endoscopic procedures.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether travel, lodging, meals, or parking are reimbursed.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to eltrekibart or mirikizumab after study participation ends.
- The study is recruiting overall, but listed locations have different statuses and a site's current availability must be confirmed.
Before contacting the site
Questions for the study team
- What are the treatment groups, allocation ratios, and chance of receiving placebo?
- How many visits are required during the approximately 69 weeks, and which visits must be in person?
- Which current ulcerative colitis medications may continue, and are any washout periods required?
- How many endoscopies and biopsies are required, and when are they performed?
- What happens if ulcerative colitis worsens during the study, including what rescue treatment is allowed?
- Which study-related and routine-care costs are covered, and is compensation or travel support available?
- Can any visits or assessments be completed remotely or through a clinician closer to home?
- Is the nearest listed site currently enrolling, and is the relevant cohort open?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks would a treatment change or washout pose in my clinical situation?
- Which of my current ulcerative colitis medicines might need to continue, change, or stop if I explore this study?
- What approved treatment alternatives should I compare with the study's eltrekibart and mirikizumab regimens?
- How might my prior treatments, clotting history, surgeries, or other gastrointestinal diagnoses affect the study team's review?
- How should my usual gastroenterology care and monitoring be coordinated with the research team if I pursue screening?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 18751
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Eltrekibart + Placebo
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Interventions: Drug: Eltrekibart, Drug: Mirikizumab, Drug: Placebo
Experimental
Mirikizumab + Placebo
Participants will receive mirikizumab and placebo or mirikizumab.
Interventions: Drug: Mirikizumab, Drug: Placebo
Experimental
Eltrekibart + Mirikizumab
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Interventions: Drug: Eltrekibart, Drug: Mirikizumab
Experimental
Placebo
Participants will receive placebo or mirikizumab.
Interventions: Drug: Mirikizumab, Drug: Placebo
Interventions
Drug
Eltrekibart
Administered
Drug
Mirikizumab
Administered
Drug
Placebo
Administered
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (5)
- Have had an established diagnosis of UC of ≥3 months in duration before baseline.Registry-derived · unreviewed
- Have moderately to severely active UC as assessed by the UC disease activity score.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Are on a stable dose of certain oral UC medications (including corticosteroids).Registry-derived · unreviewed
- Must meet contraception requirements.Registry-derived · unreviewed
Exclusion criteria (5)
- Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.Registry-derived · unreviewed
- Have experienced a thrombotic event within 24 weeks before baseline.Registry-derived · unreviewed
- Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.Registry-derived · unreviewed
- Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.Registry-derived · unreviewed
- Have a history of certain adenomas, dysplasia's, or malignancies.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants Achieving Clinical Remission
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission
Secondary outcome
Percentage of Participants Achieving Clinical Response
Time frame: Week 12
Percentage of Participants Achieving Clinical Response
Secondary outcome
Percentage of Participants Achieving Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Improvement
Secondary outcome
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 12
Percentage of Participants Achieving Endoscopic Remission
Secondary outcome
Percentage of Participants Achieving Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving Clinical Remission
Secondary outcome
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Time frame: Week 12
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Secondary outcome
Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in IBDQ Total Score
Secondary outcome
Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart
Time frame: Week 12
PK: Ctrough ss of Eltrekibart
Secondary outcome
PK: Ctrough ss of Mirikizumab
Time frame: Week 12
PK: Ctrough ss of Mirikizumab
Recruiting locations in the United States
AZ Gastro Care - Chandler
Not Yet RecruitingChandler, Arizona, 85225, United States
Jae Kim
Applied Research Center of Arkansas
RecruitingLittle Rock, Arkansas, 72205, United States
Angelo Coppola
Preferred Research Partners
Not Yet RecruitingLittle Rock, Arkansas, 72211, United States
John Baber
Erick Alayo Medical Corp/Gastro SB Clinic
RecruitingChula Vista, California, 91910, United States
Erick Alayo
Southern California GI and Liver Centers (SCLC)
RecruitingCoronado, California, 92118, United States
Tarek Hassanein
Valley View Research
RecruitingGarden Grove, California, 92845, United States
Michael Kurtz
United Medical Doctors
RecruitingLos Alamitos, California, 90720-3433, United States
Seyedehsan Navabi
Clinnova Research
RecruitingOrange, California, 92868-4402, United States
Amit Bhanvadia
Prospective Research Innovations
RecruitingRancho Cucamonga, California, 91730-4850, United States
Tarek Ezzeddine
Clinical Trials Management Services, LLC
RecruitingThousand Oaks, California, 91360, United States
MAHENDRA PATEL
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907-6262, United States
Bhaktasharan Patel
Medical Research Center of Connecticut, LLC
RecruitingHamden, Connecticut, 06518-3602, United States
Paul Feuerstadt
Novum Research, LLC
Not Yet RecruitingClermont, Florida, 34711, United States
Edriss Estime
I.V.A.M. Clinical & Investigational Center, LLC
Not Yet RecruitingDoral, Florida, 33126, United States
Jorge M. Venereo
Florida Research Institute
Not Yet RecruitingLakewood Rch, Florida, 34211, United States
Manuel Rodriguez
Well Pharma Medical Research Corp.
RecruitingMiami, Florida, 33173, United States
Eddie Armas
Digestive Disease Consultants DDCJAX
Not Yet RecruitingOrange Park, Florida, 32073-4752, United States
Samir Habashi
AdventHealth Orlando
Not Yet RecruitingOrlando, Florida, 32803, United States
Jennifer Seminerio Diehl
Orlando Health Digestive Health Institute
RecruitingOrlando, Florida, 32803-1248, United States
Udayakumar Navaneethan
International Center for Research LLC
RecruitingTampa, Florida, 33614, United States
Angel Rosario
Northwestern University
Not Yet RecruitingChicago, Illinois, 60611, United States
Keith Summa
Avicenna Clinical Research - SW Gastroenterology
RecruitingOak Lawn, Illinois, 60453-3754, United States
Charles Berkelhammer
Clinical Trials Management, LLC
Not Yet RecruitingMetairie, Louisiana, 70006, United States
David Dulitz
Gastroenterology Associates of Western Michigan, P.L.C.
RecruitingWyoming, Michigan, 49519, United States
Allan Coates
Smart Medical Research - Jackson Heights
RecruitingJackson Heights, New York, 11372, United States
Gulam Khan
Pioneer Clinical Research NY
RecruitingNew York, New York, 10012-3645, United States
Murray Orbuch
Digestive Disease Medicine of Central New York
RecruitingUtica, New York, 13502, United States
Harvey Allen
University of North Carolina
RecruitingChapel Hill, North Carolina, 27599, United States
Animesh Jain
GCGA Physicians, LLC dba / Gastro Health Research
RecruitingCincinnati, Ohio, 45219, United States
Pradeep Bekal
DHR Health Gastroenterology - Edinburg
RecruitingEdinburg, Texas, 78539, United States
Murthy Badiga
Gastroenterology Research of San Antonio
RecruitingSan Antonio, Texas, 78229, United States
Nicholas Martinez
Advanced Research Institute - South Ogden
RecruitingOgden, Utah, 84405, United States
John Lowe
University of Washington School Medicine
Not Yet RecruitingSeattle, Washington, 98195, United States
Scott Lee
This study also lists 161 locations outside the United States. They are not shown here.
Central study contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
Physicians interested in becoming principal investigators please contact
Contact
Registry dates
- First posted
- Sep 19, 2024
- Primary completion
- Dec 2027
- Overall completion
- Sep 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.