Clincosm LogoSign in Get a demo

SHINE1: A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04004611
Collaborator
(none)
30
Enrollment
37
Locations
3
Arms
34.9
Anticipated Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 18 visits.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
May 18, 2020
Anticipated Primary Completion Date :
Apr 14, 2023
Anticipated Study Completion Date :
Apr 14, 2023

Arms and Interventions

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 Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 2

    Mirikizumab administered IV and SC. Participants ≤40 kg

    Drug: Mirikizumab
    Administered IV and SC
    Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Dose 3

    Mirikizumab administered IV and SC. Participants ≤40 kg

    Drug: Mirikizumab
    Administered IV and SC
    Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Clearance of Mirikizumab [Baseline through Week 52]

      Clearance of Mirikizumab

    Secondary Outcome Measures

    1. Percentage of Participants in Clinical Remission [Week 52]

      Clinical Remission based on the modified Mayo Score (MMS)

    2. Percentage of Participants in Clinical Response [Week 52]

      Clinical Response based on the MMS

    3. Percentage of Participants Who are in MMS Clinical Remission Without the Use of Corticosteroids [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) [Week 52]

      Clinical Remission based on the PUCAI

    5. Percentage of Participants in Clinical Response Based on the PUCAI [Week 52]

      Clinical Response based on the PUCAI

    6. Percentage of Participants in Endoscopic Remission [Week 52]

      Endoscopic Remission based on the MMS Endoscopic Subscore (ES)

    7. Percentage of Participants in Symptomatic Remission [Week 52]

      Symptomatic Remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) Subscores

    8. Height Velocity (in Centimeters/Year) [Week 52]

      Height Velocity (in Centimeters/Year)

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

      Change from Baseline in Body Weight

    10. Percentage of Participants with Histologic-Endoscopic Mucosal Remission [Week 52]

      Combination of endoscopic remission and 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 [Baseline, Week 52]

      Change from baseline in 7-day average of Abdominal Pain NRS score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • 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

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Childrens Hospital of Orange County Orange California United States 92868
    2 UCSF Medical Center at Mission Bay San Francisco California United States 94158
    3 Children's Hospital of Colorado Denver Colorado United States 80045
    4 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    5 Emory University Atlanta Georgia United States 30322
    6 Children's Center for Digestive Health Care, LLC Atlanta Georgia United States 30342
    7 University of Chicago Hospital Chicago Illinois United States 60637
    8 Riley Hospital for Children Carmel Indiana United States 46302
    9 Boston Children's Hospital Boston Massachusetts United States 02115
    10 MGH for Children - Waltham Waltham Massachusetts United States 02451
    11 Washington University School of Medicine Saint Louis Missouri United States 63110
    12 Goryeb Children's Hospital / Atlantic Health System Morristown New Jersey United States 07960
    13 Icahn Sch of Med at Mt. Sinai New York New York United States 10029
    14 Cincinnati Childrens Hospital Medical Center Cincinnati Ohio United States 45229
    15 The Abbigail Wexner Research Institute at Nationwide Children's Hospital Columbus Ohio United States 43205
    16 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    17 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    18 Cook Children's Hospital Fort Worth Texas United States 76104
    19 Texas Childrens Hospital Houston Texas United States 77030
    20 Pediatrics Specialists of Virginia Fairfax Virginia United States 22031
    21 Children's Hospital of The King's Daughters Inc Norfolk Virginia United States 23507
    22 Seattle Children's Hospital Research Foundation Seattle Washington United States 98105
    23 University of Alberta Hospital Edmonton Alberta Canada T6G 1C9
    24 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    25 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    26 Rambam Medical Center Haifa Israel 3109601
    27 The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center Jerusalem Israel
    28 Schneider Children's Medical Center Petah Tiqva Israel 4920235
    29 Kurume University Hospital Kurume Fukuoka Japan 830-0011
    30 Saiseikai Yokohamashi Tobu Hospital Yokohama Kanagawa Japan 2308765
    31 Saitama Children's Medical Center Saitama-shi Saitama Japan 330 8777
    32 Juntendo University Hospital Bunkyo-ku Tokyo Japan 113-8431
    33 Tokyo Medical and Dental University Hospital Bunkyō Tokyo Japan 113-8519
    34 National Center For Child Health And Development Setagaya-ku Tokyo Japan 157-8535
    35 Tokyo Medical University Hospital Shinjuku-ku Tokyo Japan 160-0023
    36 Kyungpook National University Medical Center Chilgok Hospital Daegu Korea, Republic of 41404
    37 Seoul National University Hospital Seoul Korea, Republic of 3080

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04004611
    Other Study ID Numbers:
    • 17410
    • I6T-MC-AMBU
    First Posted:
    Jul 2, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 15, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Mirikizumab

    Study Results

    No Results Posted as of Aug 18, 2022