Phase 2 N=26 Treatment

A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT04004611 ↗

Enrolled (actual)

Serious AEs

5.8%

Results posted

Oct 2023

Primary outcome: Primary: Pharmacokinetics (PK): Clearance of Mirikizumab — 0.000190 Liters per hour per kilogram (L/hr/kg)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mirikizumab (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Clearance of Mirikizumab	0.000190	—
SECONDARY Percentage of Participants in Clinical Remission	0.0; 62.5; 55.6; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants in Clinical Response	0.0; 75.0; 88.9; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids	0.0; 62.5; 55.6; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)	0.0; 75.0; 77.8; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants in Clinical Response Based on the PUCAI	0.0; 75.0; 88.9; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants in Endoscopic Remission	0.0; 62.5; 55.6; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants in Symptomatic Remission	0.0; 75.0; 66.7; 0.0; 0.0; 0.0	—
SECONDARY Height Velocity (in Centimeters/Year)	NA; 8.65; 4.54; 4.14; 2.97; NA	—
SECONDARY Change From Baseline in Body Weight	NA; 8; 9; 9; 8; NA	—
SECONDARY Percentage of Participants With Histologic-Endoscopic Mucosal Remission	0.0; 62.5; 44.4; 0.0; 0.0; 0.0	—
SECONDARY Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12	-3; -3; NA; -4; -2; -1	—
SECONDARY Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52	NA; NA; 0; -2; -5; -4	—

Summary

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.

Eligibility Criteria

Inclusion Criteria

Participants weighing >10 kg
Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
Participants must have evidence of UC extending proximal to the rectum
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Exclusion Criteria

Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
Participants must not have had surgery to remove part of their colon
Participants must not have current evidence of toxic megacolon
Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04004611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.