Clinical trial NCT04004611: A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Official title: A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Interleukin-23 (IL-23) antibody
IL-23p19
Pediatric
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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
* 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)

Primary outcomes:
measure: Pharmacokinetics (PK): Clearance of Mirikizumab
timeFrame: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Secondary outcomes:
measure: Percentage of Participants in Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants in Clinical Response
timeFrame: Week 52
measure: Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
timeFrame: Week 52
measure: Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
timeFrame: Week 52
measure: Percentage of Participants in Clinical Response Based on the PUCAI
timeFrame: Week 52
measure: Percentage of Participants in Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants in Symptomatic Remission
timeFrame: Week 52
measure: Height Velocity (in Centimeters/Year)
timeFrame: Week 52
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Histologic-Endoscopic Mucosal Remission
timeFrame: Week 52
measure: Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Denver
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care, LLC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Carmel
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: MGH for Children - Waltham
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Morristown
country: United States
facility: Goryeb Children's Hospital / Atlantic Health System
state: New Jersey
city: New York
country: United States
facility: Icahn Sch of Med at Mt. Sinai
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Abbigail Wexner Research Institute at Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Fairfax
country: United States
facility: Pediatrics Specialists of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters Inc
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Foundation
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
city: Petah Tiqva
country: Israel
facility: Schneider Children's Medical Center
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center For Child Health And Development
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: