Ulcerative ColitisPhase 3SHINE-2NCT05784246
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
A Phase 3 study testing Mirikizumab IV and Mirikizumab SC in people with Ulcerative Colitis, run by Eli Lilly and Company at 34 sites in 11 countries.
Trial summary
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC). 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 IV and Mirikizumab SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 34 sitesin 11 countries
- Study dates
- 22 Nov 2023to 1 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
- Have moderate to severe UC.
- Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
- Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
Who cannot join
- Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- Have immune deficiency syndrome.
- Previous bowel resection or intestinal surgery.
- Evidence of toxic megacolon.
- History or current evidence of cancer of the gastrointestinal tract.
Trial locations and contacts
34 sites in 11 countries.
34 sites in 11 countries
United States6 sites
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Riley Childrens Hospital
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of California, San Francisco
San Francisco, California, 94158
Washington University
St Louis, Missouri, 63110-1010
Japan6 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Institute of Science Tokyo Hospital
Bunkyō City, 113-8519
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871
Saga University Hospital
Saga, 849-8501
National Center for Child Health and Development
Setagaya-ku, 157-8535
Yokohama City University Medical Center, Center of IBD
Yokohama, 232-0024
Poland5 sites
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin, 71-434
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw, 04-730
Centrum Medyczne Oporow
Wroclaw, 52-416
Israel4 sites
Shaare Zedek
Jerusalem, 9103102
Hadassah University Hospital, Ein Kerem
Jerusalem, 911200
Schneider Children's Medical Center
Petah Tikva, 4920235
King Fahad Medical City
Rishon LeZiyyon, 70300
Germany3 sites
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
LMU-Campus Innenstadt
München, 80337
Helios Klinikum Wuppertal
Wuppertal, 42283
South Korea3 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Severance Hospital, Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
Italy2 sites
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, 50139
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161
About this study
Official title: A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Read the detailed description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
- Conditions
- Ulcerative Colitis
- Being tested
- Mirikizumab IV, Mirikizumab SC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab IVDrug
Also called LY3074828
Administered IV
Mirikizumab SCDrug
Also called LY3074828
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab Weight-Based Group 1 | Experimental | Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). Receives: Drug: Mirikizumab IV; Drug: Mirikizumab SC |
| Mirikizumab Weight-Based Group 2 | Experimental | Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. Receives: Drug: Mirikizumab IV; Drug: Mirikizumab SC |
| Mirikizumab Weight-Based Group 3 | Experimental | Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. Receives: Drug: Mirikizumab IV; Drug: Mirikizumab SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Measured: Baseline to Week 52
Secondary outcomes (17)
Percentage of Participants in MMS Clinical Remission
Measured: Week 12
Percentage of Participants in MMS Clinical Response
Measured: Week 12
Percentage of Participants with Endoscopic Remission
Measured: Week 12
Percentage of Participants with Endoscopic Improvement
Measured: Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Measured: Week 12
Percentage of Participants Achieving PUCAI Clinical Remission
Measured: Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Measured: Week 12
Percentage of Participants Achieving MMS Clinical Response
Measured: Week 52
Percentage of Participants Achieving MMS Clinical Remission
Measured: Week 52
Percentage of Participants Achieving PUCAI Clinical Response
Measured: Week 52
Percentage of Participants Achieving PUCAI Clinical Remission
Measured: Week 52
Percentage of Participants Achieving Endoscopic Remission
Measured: Week 52
Percentage of Participants Achieving Endoscopic Improvement
Measured: Week 52
Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids
Measured: Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Measured: Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
PK: AUC of Mirikizumab
Measured: Baseline to Week 52
PK: Cmax of Mirikizumab
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start22 Nov 2023
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784246
- Sponsor's protocol ID
- 16634
- Other IDs
- I6T-MC-AMBA, 2022-502183-20-00
- Acronym
- SHINE-2
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05784246
- Acronym / sponsor ID
- SHINE-2 / 16634
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Detailed description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab Weight-Based Group 1 | Experimental | Drug: Mirikizumab IV, Drug: Mirikizumab SCExperimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). |
| Mirikizumab Weight-Based Group 2 | Experimental | Drug: Mirikizumab IV, Drug: Mirikizumab SCExperimental: Participants will receive mirikizumab weight-based dosing IV or SC. |
| Mirikizumab Weight-Based Group 3 | Experimental | Drug: Mirikizumab IV, Drug: Mirikizumab SCExperimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
- Have moderate to severe UC.
- Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
- Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
Key exclusion criteria (5 listed)
- Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- Have immune deficiency syndrome.
- Previous bowel resection or intestinal surgery.
- Evidence of toxic megacolon.
- History or current evidence of cancer of the gastrointestinal tract.
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 |
|---|---|---|
| Mirikizumab IVAlso: LY3074828Administered IV | Drug | Mirikizumab Weight-Based Group 1, Mirikizumab Weight-Based Group 2, Mirikizumab Weight-Based Group 3 |
| Mirikizumab SCAlso: LY3074828Administered SC | Drug | Mirikizumab Weight-Based Group 1, Mirikizumab Weight-Based Group 2, Mirikizumab Weight-Based Group 3 |
Primary outcome
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Time frame: Baseline to Week 52
17 secondary outcomes
Percentage of Participants in MMS Clinical Remission
Time frame: Week 12
Percentage of Participants in MMS Clinical Response
Time frame: Week 12
Percentage of Participants with Endoscopic Remission
Time frame: Week 12
Percentage of Participants with Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Time frame: Week 12
Percentage of Participants Achieving PUCAI Clinical Remission
Time frame: Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time frame: Week 12
Percentage of Participants Achieving MMS Clinical Response
Time frame: Week 52
Percentage of Participants Achieving MMS Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving PUCAI Clinical Response
Time frame: Week 52
Percentage of Participants Achieving PUCAI Clinical Remission
Time frame: Week 52
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 52
Percentage of Participants Achieving Endoscopic Improvement
Time frame: Week 52
Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids
Time frame: Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time frame: Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
Time frame: Baseline to Week 52
PK: Cmax of Mirikizumab
Time frame: Baseline to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
34 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirikizumab IV and Mirikizumab SC in people with Ulcerative Colitis, run by Eli Lilly and Company at 34 sites in 11 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 4 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Japan, Poland, Israel, Germany and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.