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A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (SHINE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004611
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study is designed to evaluate how the body processes and gets rid of mirikizumab. The study will also evaluate safety and response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 17 visits.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mirikizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
Estimated Study Start Date : December 12, 2019
Estimated Primary Completion Date : April 22, 2022
Estimated Study Completion Date : April 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)
Drug: Mirikizumab
Administered IV and SC
Other Name: LY3074828

Experimental: Mirikizumab Dose 2
Mirikizumab administered IV and SC. Participants ≤40 kg
Drug: Mirikizumab
Administered IV and SC
Other Name: LY3074828

Experimental: Mirikizumab Dose 3
Mirikizumab administered IV and SC. Participants ≤40 kg
Drug: Mirikizumab
Administered IV and SC
Other Name: LY3074828




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Baseline through Week 24 ]
    Clearance of Mirikizumab


Secondary Outcome Measures :
  1. Percentage of Participants in Clinical Remission [ Time Frame: Week 12 ]
    Clinical Remission based on the modified Mayo Score (MMS)

  2. Percentage of Participants in Clinical Response [ Time Frame: Week 12 ]
    Clinical Response based on the MMS

  3. Percentage of Participants who Entered the Study on Corticosteroids and who are in MMS Clinical Remission without the use of Corticosteroids [ Time Frame: Week 52 ]
    Corticosteroid-free Clinical Remission based on the MMS

  4. Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI) [ Time Frame: Week 12 ]
    Clinical Remission based on the PUCAI

  5. Percentage of Participants in Clinical Response Based on the PUCAI [ Time Frame: Week 12 ]
    Clinical Response based on the PUCAI

  6. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic Remission based on the MMS Endoscopic Subscore (ES)

  7. Percentage of Participants in Symptomatic Remission [ Time Frame: Week 12 ]
    Symptomatic Remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) Subscores

  8. Height Velocity (in Centimeters/Year) [ Time Frame: Week 26, Week 52 ]
    Height Velocity (in Centimeters/Year)

  9. Change from Baseline in Body Weight [ Time Frame: Week 52 ]
    Change from Baseline in Body Weight

  10. Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]
    Mucosal healing based on a histologic disease activity index

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
  • Have evidence of UC extending proximal to the rectum
  • Participants 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 therapy for UC

Exclusion Criteria:

  • Participants with 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 with current evidence of toxic megacolon
  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004611


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

  Show 32 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04004611     History of Changes
Other Study ID Numbers: 17410
I6T-MC-AMBU ( Other Identifier: Eli Lilly and Company )
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Interleukin-23 (IL-23) antibody
IL-23p19
Pediatric
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases