Ulcerative Colitis, Ulcerative Colitis Chronic
Conditions
Keywords
CXCR1/2 Ligand receptor antagonist, IL-23 p19 antibody, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Colitis, Colitis, Ulcerative, Anti-Inflammatory Agents, Mirikizumab, Eltrekibart, Adult, Moderate to Severe
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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). * Must meet contraception requirements.
Exclusion criteria
* 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. * Have a history of certain adenomas, dysplasia's, or malignancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission | Week 12 | Percentage of Participants Achieving Clinical Remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Response | Week 12 | Percentage of Participants Achieving Clinical Response |
| Percentage of Participants Achieving Endoscopic Improvement | Week 12 | Percentage of Participants Achieving Endoscopic Improvement |
| Percentage of Participants Achieving Endoscopic Remission | Week 12 | Percentage of Participants Achieving Endoscopic Remission |
| Percentage of Participants Achieving Clinical Remission | Week 52 | Percentage of Participants Achieving Clinical Remission |
| Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement | Week 12 | Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement |
| Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | Baseline, Week 12 | Change From Baseline to Week 12 in IBDQ Total Score |
| Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart | Week 12 | PK: Ctrough ss of Eltrekibart |
| PK: Ctrough ss of Mirikizumab | Week 12 | PK: Ctrough ss of Mirikizumab |
Countries
Argentina, Belgium, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Poland, Romania, Serbia, Spain, Turkey (Türkiye), United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed