Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04004611 · ClinicalTrials.gov registry record · Phase 2
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
A Phase 2 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 20
- Study locations
NCT04004611: Completed Phase 2 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
NCT04004611 is a Phase 2 study of Ulcerative Colitis that has completed, run by Eli Lilly and Company. The registered enrollment target is 26 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04004611, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Conditions Studied
Interventions
- DRUG Mirikizumab
Study Locations (20)
California
- Childrens Hospital of Orange County - Orange
- UCSF Medical Center at Mission Bay - San Francisco
Georgia
- Emory University - Atlanta
- Children's Center for Digestive Health Care, LLC - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
- MGH for Children - Waltham - Waltham
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
- The Abbigail Wexner Research Institute at Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Texas
- Cook Children's Hospital - Fort Worth
- Texas Childrens Hospital - Houston
Colorado
- Children's Hospital of Colorado - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-05-18 |
| Est. Completion | 2023-03-15 |
| Phase | Phase 2 |
What the finished NCT04004611 record still lists
NCT04004611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Mirikizumab is the first listed.
NCT04004611 names 20 study sites across 14 states, led by California, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04004611 about?
NCT04004611 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)". 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.
What is the current status of trial NCT04004611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2020-05-18. Estimated completion is 2023-03-15.
What conditions does trial NCT04004611 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04004611?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT04004611?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04004611 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04004611's enrollment target sits among peer trials
26 107th of 122 higher than 15 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
RECRUITING · Phase 2
-
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
RECRUITING · Phase 2
-
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
RECRUITING · Phase 2
-
Treatment of UC With Novel Therapeutics
RECRUITING · Phase 2
-
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
RECRUITING · Phase 2
-
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI