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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Administered IV and SC
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Time frame: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Percentage of Participants in Clinical Remission
Clinical remission at week 52 is defined as achieving a 9-point modified Mayo score (MMS) for rectal bleeding (RB) = 0, stool frequency (SF) = 0 or 1 and endoscopy (ES) = 0 or 1 (excluding friability). The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration.
Time frame: Week 52
Percentage of Participants in Clinical Response
Clinical response at week 52 is defined as a decrease in the 9-point modified Mayo score (MMS) \[rectal bleeding, stool frequency and the endoscopic findings\] inclusive of ≥2 points and ≥30% from baseline with either a decrease of rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
Time frame: Week 52
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
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Childrens Hospital of Orange County
Orange, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Riley Hospital for Children
Carmel, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MGH for Children - Waltham
Waltham, Massachusetts, United States
...and 27 more locations
Corticosteroid-free clinical remission was defined as an SF subscore = 0 or 1, RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 52-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: Week 52
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
The PUCAI is a clinician-administered, 6-item questionnaire that measures: abdominal pain; RB; stool consistency; number of stools; nocturnal stools; and activity level. For PUCAI score all items are answered as an average over the 'past 2 days'. A total disease activity score is calculated from 0 to 85, with Severe 65-85; Moderate:35-60; Mild:10-30, and None:\<10. The clinician will record the participant or caregiver/legal guardian responses for the PUCAI electronically as source data in the tablet device at appropriate visits. PUCAI clinical remission is defined as a PUCAI score of \<10 points.
Time frame: Week 52
Percentage of Participants in Clinical Response Based on the PUCAI
PUCAI clinical response is defined as a reduction in baseline PUCAI score of ≥20 points.
Time frame: Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 52. ES subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
Time frame: Week 52
Percentage of Participants in Symptomatic Remission
Symptomatic remission at week 52 is defined as a Mayo score for RB=0, SF=0 or 1 with ≥ 1 point decrease from baseline. SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
Time frame: Week 52
Height Velocity (in Centimeters/Year)
Observed height velocity by gender and age group was calculated. Age groups for which this was summarized were 2 to \<8, 8 to \<12, and 12 to \<18. Observed height velocity by gender and age group was calculated at baseline according to the following formula: (Present Height \[cm\] - Previous Height \[cm\])/Interval (months) Between Measurements × 12.
Time frame: Week 52
Change From Baseline in Body Weight
Change from Baseline in body weight by gender and age group was calculated.
Time frame: Baseline, Week 52
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
Histologic-endoscopic mucosal remission is defined as achieving both histologic remission and endoscopic remission. Histologic remission is defined as Geboes histological subscores of 0 for parameters: 2B (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction), and 5 (erosion or ulceration).
Time frame: Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children \< 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Time frame: Baseline, Week 12
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children \< 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Time frame: Baseline, Week 52