A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
- Conditions
- - Crohn´s Disease.- Moderately to severely active Ulcerative Colitis.MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-005311-49-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
- Participants from originating studies who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab;
- Female participants must agree to contraception requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
– Participants must not be pregnant, breastfeeding, or planning pregnancy while enrolled in the study, or within 16 weeks (last dose IV) or 12 weeks (last dose SC) after receiving the last dose of study drug;
- Participants must not have developed any adverse event in the originator study that the PI or sponsor considers that continued treatment with mirikizumab may present an unreasonable risk for the participant;
- Participants must not have developed or uncontrolled illness, including but not limited to cerebro-cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, hematologic, or neurological disorders that would potentially affect participant safety within the study or confound efficacy assessment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method