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Monoclonal Antibodies
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (SHINE-1 Trial)
Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Awards & highlights
No Placebo-Only Group
Summary
This trial tested mirikizumab, a medication that targets the immune system, in children with Ulcerative Colitis. It aimed to see how the body processes and removes the drug, and to check its safety and effectiveness over several months. Mirikizumab has shown promise in treating ulcerative colitis.
Eligible Conditions
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pharmacokinetics (PK): Clearance of Mirikizumab
Secondary study objectives
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
Change From Baseline in Body Weight
+9 moreSide effects data
From 2020 Phase 3 trial • 530 Patients • NCT0348201114%
Nasopharyngitis
6%
Headache
6%
Upper respiratory tract infection
6%
Injection site pain
4%
Pelvic inflammatory disease
4%
Back pain
4%
Dysmenorrhoea
3%
Arthralgia
3%
Dermatitis contact
3%
Hypertension
3%
Pharyngitis
3%
Urinary tract infection
2%
Oedema peripheral
2%
Folliculitis
2%
Oral herpes
2%
Contusion
2%
Hypertriglyceridaemia
2%
Osteoarthritis
2%
Injection site reaction
2%
Bronchitis
2%
Meniscus injury
2%
Blood pressure increased
2%
Cough
2%
Pruritus
2%
Toothache
2%
Weight increased
2%
Musculoskeletal chest pain
2%
Pain in extremity
1%
Oropharyngeal pain
1%
Tonsillitis
1%
Rhinitis allergic
1%
Groin pain
1%
Erysipelas
1%
Respiratory tract infection
1%
Leukocytosis
1%
Cardiac failure chronic
1%
Food poisoning
1%
Gastrointestinal disorder
1%
Gingival atrophy
1%
Chest pain
1%
Injection site erythema
1%
Gastroenteritis viral
1%
Gastrointestinal infection
1%
Pharyngotonsillitis
1%
Hepatic enzyme increased
1%
Overweight
1%
Joint effusion
1%
Pollakiuria
1%
Rhinorrhoea
1%
Dermal cyst
1%
Rash
1%
Urticaria
1%
Wisdom teeth removal
1%
Ingrowing nail
1%
Pain
1%
Arthropod sting
1%
Palpitations
1%
Stomatitis
1%
Injection site induration
1%
Malaise
1%
Otitis media
1%
Paronychia
1%
Tracheitis
1%
Aspartate aminotransferase increased
1%
Joint swelling
1%
Muscle spasms
1%
Rotator cuff syndrome
1%
Erythema
1%
Atrial fibrillation
1%
Glossitis
1%
Injection site pruritus
1%
Ear infection
1%
Animal bite
1%
Wound complication
1%
Blood triglycerides increased
1%
C-reactive protein increased
1%
Electrocardiogram qt prolonged
1%
Gamma-glutamyltransferase increased
1%
Type 2 diabetes mellitus
1%
Facial paralysis
1%
Sinus headache
1%
Dry mouth
1%
Alanine aminotransferase increased
1%
Muscle tightness
1%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
250 mg Miri Q4W Responders to 125 mg Miri Q8W
250 mg Miri Q4W Responder to 250 mg Miri Q8W
250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period
250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period
250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)
Placebo Q4W to Placebo Non-Responder-Follow-up Period
250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period
250 Miri Q4W Discontinued During Induction-Follow-up
250 Miri Q4W to Miri Nonresponder-Follow-up Period
Placebo Q4W
250 mg Miri Q4W
Placebo Q4W to Placebo Q8W (Placebo Responder)
Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)
250 mg Miri Q4W Responders to Placebo Q8W
Relapse
Placebo Q4W to Placebo Q8W (Responder) Follow-up Period
Placebo Q4W Discontinued During Induction-Follow-up Period
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
9Treatment groups
Experimental Treatment
Group I: Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SCExperimental Treatment1 Intervention
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Group II: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SCExperimental Treatment1 Intervention
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Group III: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SCExperimental Treatment1 Intervention
Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Group IV: Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)Experimental Treatment1 Intervention
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
Group V: Open Label Maintenance Period: 200 mg Miri SCExperimental Treatment1 Intervention
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Group VI: Open Label Maintenance Period: 100 mg Miri SCExperimental Treatment1 Intervention
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Group VII: Open Label Induction Period: 300 mg Miri IVExperimental Treatment1 Intervention
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Group VIII: Open Label Induction Period: 10 mg/kg Miri IVExperimental Treatment1 Intervention
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Group IX: Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)Experimental Treatment1 Intervention
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~6070
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,727 Total Patients Enrolled
11 Trials studying Colitis
4,461 Patients Enrolled for Colitis
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
428,142 Total Patients Enrolled
9 Trials studying Colitis
4,211 Patients Enrolled for Colitis