Ulcerative ColitisPhase 2SHINE-1NCT04004611
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
A Phase 2 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 37 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mirikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 37 sitesin 5 countries
- Study dates
- 18 May 2020to 15 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
United States22 sites
Emory University
Atlanta, Georgia, 30322
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342
Boston Children's Hospital
Boston, Massachusetts, 02115
Riley Hospital for Children
Carmel, Indiana, 46302
University of Chicago Hospital
Chicago, Illinois, 60637
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
The Abbigail Wexner Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Colorado
Denver, Colorado, 80045
Pediatrics Specialists of Virginia
Fairfax, Virginia, 22031
Cook Children's Hospital
Fort Worth, Texas, 76104
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Texas Childrens Hospital
Houston, Texas, 77030
Goryeb Children's Hospital / Atlantic Health System
Morristown, New Jersey, 07960
Icahn Sch of Med at Mt. Sinai
New York, New York, 10029
Children's Hospital of The King's Daughters Inc
Norfolk, Virginia, 23507
Childrens Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
MGH for Children - Waltham
Waltham, Massachusetts, 02451
Japan7 sites
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo, 113-8519
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Saitama Children's Medical Center
Saitama-shi, Saitama, 330 8777
National Center For Child Health And Development
Setagaya-ku, Tokyo, 157-8535
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 2308765
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 1C9
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Israel3 sites
Rambam Medical Center
Haifa, 3109601
The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
Jerusalem
Schneider Children's Medical Center
Petah Tikva, 4920235
South Korea2 sites
Kyungpook National University Medical Center Chilgok Hospital
Daegu, 41404
Seoul National University Hospital
Seoul, 3080
About this study
Official title: A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Mirikizumab
- Keywords
- Interleukin-23 (IL-23) antibody, IL-23p19, Pediatric
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Also called LY3074828
Administered IV and SC
| Study group | Role | What they receive |
|---|---|---|
| Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV) | Experimental | Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks. Receives: Drug: Mirikizumab |
| Open Label Induction Period: 10 mg/kg Miri IV | Experimental | Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. Receives: Drug: Mirikizumab |
| Open Label Induction Period: 300 mg Miri IV | Experimental | Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: 50 mg Miri subcutaneous (SC) | Experimental | Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: 100 mg Miri SC | Experimental | Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: 200 mg Miri SC | Experimental | Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC | Experimental | Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC | Experimental | Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
| Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC | Experimental | Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed. Receives: Drug: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Clearance of Mirikizumab
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.
Measured: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Secondary outcomes (12)
Percentage of Participants in Clinical Remission
Clinical remission at week 52 is defined as achieving a 9-point modified Mayo score (MMS) for rectal bleeding (RB) = 0, stool frequency (SF) = 0 or 1 and endoscopy (ES) = 0 or 1 (excluding friability). The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration.
Measured: Week 52
Percentage of Participants in Clinical Response
Clinical response at week 52 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of ≥2 points and ≥30% from baseline with either a decrease of rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
Measured: Week 52
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
Corticosteroid-free clinical remission was defined as an SF subscore = 0 or 1, RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 52-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Measured: Week 52
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
The PUCAI is a clinician-administered, 6-item questionnaire that measures: abdominal pain; RB; stool consistency; number of stools; nocturnal stools; and activity level. For PUCAI score all items are answered as an average over the 'past 2 days'. A total disease activity score is calculated from 0 to 85, with Severe 65-85; Moderate:35-60; Mild:10-30, and None:<10. The clinician will record the participant or caregiver/legal guardian responses for the PUCAI electronically as source data in the tablet device at appropriate visits. PUCAI clinical remission is defined as a PUCAI score of <10 points.
Measured: Week 52
Percentage of Participants in Clinical Response Based on the PUCAI
PUCAI clinical response is defined as a reduction in baseline PUCAI score of ≥20 points.
Measured: Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 52. ES subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
Measured: Week 52
Percentage of Participants in Symptomatic Remission
Symptomatic remission at week 52 is defined as a Mayo score for RB=0, SF=0 or 1 with ≥ 1 point decrease from baseline.
SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).
RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
Measured: Week 52
Height Velocity (in Centimeters/Year)
Observed height velocity by gender and age group was calculated. Age groups for which this was summarized were 2 to <8, 8 to <12, and 12 to <18. Observed height velocity by gender and age group was calculated at baseline according to the following formula: (Present Height [cm] - Previous Height [cm])/Interval (months) Between Measurements × 12.
Measured: Week 52
Change From Baseline in Body Weight
Change from Baseline in body weight by gender and age group was calculated.
Measured: Baseline, Week 52
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
Histologic-endoscopic mucosal remission is defined as achieving both histologic remission and endoscopic remission. Histologic remission is defined as Geboes histological subscores of 0 for parameters: 2B (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction), and 5 (erosion or ulceration).
Measured: Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Measured: Baseline, Week 12
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start18 May 2020
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004611
- Sponsor's protocol ID
- 17410
- Other IDs
- I6T-MC-AMBU, 2019-001298-96, 2019
- Acronym
- SHINE-1
- Status last verified
- Mar 2024
- First submitted
- 29 Jun 2019
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Kaplan JL, Bousvaros A, Turner D, Dubinsky M, Larkin A, Johns J, Otani Y, Crandall W, Komocsar WJ, Hyams JS. Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):100-109. doi: 10.1016/S2468-1253(25)00196-7. Epub 2025 Nov 19.
PubMed 41270771
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04004611
- Acronym / sponsor ID
- SHINE-1 / 17410
- Conditions
- Ulcerative Colitis
- Keywords
- Interleukin-23 (IL-23) antibody, IL-23p19, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV) | Experimental | Drug: MirikizumabParticipants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks. |
| Open Label Induction Period: 10 mg/kg Miri IV | Experimental | Drug: MirikizumabParticipants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. |
| Open Label Induction Period: 300 mg Miri IV | Experimental | Drug: MirikizumabParticipants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. |
| Open Label Maintenance Period: 50 mg Miri subcutaneous (SC) | Experimental | Drug: MirikizumabParticipants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: 100 mg Miri SC | Experimental | Drug: MirikizumabParticipants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: 200 mg Miri SC | Experimental | Drug: MirikizumabParticipants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC | Experimental | Drug: MirikizumabParticipants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC | Experimental | Drug: MirikizumabParticipants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC | Experimental | Drug: MirikizumabParticipants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirikizumabAlso: LY3074828Administered IV and SC | Drug | Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV), Open Label Induction Period: 10 mg/kg Miri IV, Open Label Induction Period: 300 mg Miri IV, Open Label Maintenance Period: 100 mg Miri SC, Open Label Maintenance Period: 200 mg Miri SC, Open Label Maintenance Period: 50 mg Miri subcutaneous (SC), Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC, Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC, Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC |
Primary outcome
Pharmacokinetics (PK): Clearance of Mirikizumab
Time frame: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
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.
12 secondary outcomes
Percentage of Participants in Clinical Remission
Time frame: Week 52
Percentage of Participants in Clinical Response
Time frame: Week 52
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
Time frame: Week 52
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time frame: Week 52
Percentage of Participants in Clinical Response Based on the PUCAI
Time frame: Week 52
Percentage of Participants in Endoscopic Remission
Time frame: Week 52
Percentage of Participants in Symptomatic Remission
Time frame: Week 52
Height Velocity (in Centimeters/Year)
Time frame: Week 52
Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
Time frame: Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41270771Kaplan JL, Bousvaros A, Turner D, Dubinsky M, Larkin A, Johns J, Otani Y, Crandall W, Komocsar WJ, Hyams JS. Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):100-109. doi: 10.1016/S2468-1253(25)00196-7. Epub 2025 Nov 19.
- A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Japan, Canada, Israel, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Clearance of Mirikizumab (time frame: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.