A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

JRCT ID: jRCT2051230129

Registered date:11/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's Disease
• Date of first enrollment: 31/05/2024
• Target sample size: 90
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,France,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Mirikizumab
Administered IV or SC
Other Name: LY3074828

Study Arms
Experimental: Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Intervention: Drug: Mirikizumab
Experimental: Mirikizumab Dose 2
Mirikizumab administered IV or SC in participants that weigh >20 kg to less than or equal to (<=) 40 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Intervention: Drug: Mirikizumab
Experimental: Mirikizumab Dose 3
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (>=)10 kg to less than or equal to <=20 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Intervention: Drug: Mirikizumab

Outcome(s)

Primary Outcome

Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ]
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ]
Clinical response based on PCDAI, and clinical remission based on PCDAI.

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
Participants must have endoscopy with evidence of active CD defined as as SES-CD score >=6 (or >=4 for participants with isolated ileal disease) during screening into this study.
Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclude criteria

Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
Participants must not have an abscess.
Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05509777