EUCTR2020-005311-49-PLActive, not recruitingPhase 1
Master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn’s disease - SHINE-O
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •– 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.
Investigators
Similar Trials
Recruiting
Phase 3
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's DiseaseJPRN-jRCT2031210210Masaki Takeshi5
Active, not recruiting
Phase 1
An extension study to enable patients to continue to receive Guanfacine Hydrocloride Extended Release tablets after completing either study SPD503-315 or SPD503-316.Attention Deficit/Hyperactivity Disorder (ADHD)MedDRA version: 17.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873EUCTR2011-004668-31-GBShire Pharmaceutical Development Ltd249
Active, not recruiting
Phase 1
A clinical trial investigating safety and efficacy of a long-acting factor VIIIin children (age <12 years) with severe hemophila Asevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-004434-42-GBBayer AG61
Active, not recruiting
Phase 1
A clinical trial investigating safety and efficacy of a long-acting factor VIIIin children (age <12 years) with severe hemophila Asevere hemophilia A (<1% FVIII:C)MedDRA version: 18.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 18.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-004434-42-NOBayer HealthCare AG60
Active, not recruiting
Not Applicable
A clinical trial investigating safety and efficacy of a long-acting factor VIIIin children (age <12 years) with severe hemophila AEUCTR2012-004434-42-Outside-EU/EEABayer HealthCare AG60