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

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ClinicalTrials.gov Identifier: NCT04004611
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 29, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date November 5, 2019
Estimated Study Start Date  ICMJE December 12, 2019
Estimated Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Baseline through Week 24 ]
Clearance of Mirikizumab
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04004611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2019)
  • Percentage of Participants in Clinical Remission [ Time Frame: Week 12 ]
    Clinical Remission based on the modified Mayo Score (MMS)
  • Percentage of Participants in Clinical Response [ Time Frame: Week 12 ]
    Clinical Response based on the MMS
  • 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
  • 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
  • Percentage of Participants in Clinical Response Based on the PUCAI [ Time Frame: Week 12 ]
    Clinical Response based on the PUCAI
  • Percentage of Participants in Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic Remission based on the MMS Endoscopic Subscore (ES)
  • Percentage of Participants in Symptomatic Remission [ Time Frame: Week 12 ]
    Symptomatic Remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) Subscores
  • Height Velocity (in Centimeters/Year) [ Time Frame: Week 26, Week 52 ]
    Height Velocity (in Centimeters/Year)
  • Change from Baseline in Body Weight [ Time Frame: Week 52 ]
    Change from Baseline in Body Weight
  • Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]
    Mucosal healing based on a histologic disease activity index
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Official Title  ICMJE Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Mirikizumab
Administered IV and SC
Other Name: LY3074828
Study Arms  ICMJE
  • Experimental: Mirikizumab Dose 1
    Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)
    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose 2
    Mirikizumab administered IV and SC. Participants ≤40 kg
    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose 3
    Mirikizumab administered IV and SC. Participants ≤40 kg
    Intervention: Drug: Mirikizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 22, 2022
Estimated Primary Completion Date April 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004611
Other Study ID Numbers  ICMJE 17410
I6T-MC-AMBU ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP