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Monoclonal Antibodies

Mirikizumab for Pediatric Crohn's Disease (AMAY Trial)

Phase 3
Recruiting
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 week 52
Awards & highlights

Summary

This trial will evaluate an experimental drug to treat Crohn's disease in children. Participants will randomly be assigned to receive the drug or another intervention. The study will last 74 weeks with up to 19 visits.

Who is the study for?
This trial is for pediatric patients with moderately to severely active Crohn's Disease, confirmed by specific medical criteria. They should have tried at least one treatment without success or could not tolerate it. Kids who've had recent bowel surgery or have complications like strictures that might need surgery can't join.
What is being tested?
The study tests Mirikizumab's effectiveness and safety in children with Crohn's Disease over approximately 74 weeks, including a 12-week induction phase and up to Week 52 maintenance period, followed by a safety follow-up. Participants are randomly assigned to receive either Mirikizumab or another intervention.
What are the potential side effects?
While the exact side effects for this age group aren't listed, similar drugs often cause immune system reactions, injection site discomfort, digestive issues, headaches, and potential increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Secondary study objectives
Percentage of Participants Achieving Clinical Remission by CDAI
Percentage of Participants Achieving Clinical Remission by PCDAI
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
+5 more

Side effects data

From 2020 Phase 3 trial • 530 Patients • NCT03482011
11%
Upper respiratory tract infection
10%
Nasopharyngitis
7%
Injection site pain
4%
Headache
4%
Cough
4%
Pharyngitis
3%
Gastroenteritis
3%
Arthralgia
3%
Salpingo-oophoritis
3%
Diarrhoea
3%
Hepatic steatosis
3%
Bronchitis
3%
Influenza
3%
Dysmenorrhoea
2%
Malaise
2%
Back pain
2%
Hypertension
2%
Aspartate aminotransferase increased
2%
Gout
2%
Oropharyngeal pain
2%
Erectile dysfunction
2%
Pruritus
2%
Toothache
2%
Urinary tract infection
2%
Ligament sprain
2%
Gamma-glutamyltransferase increased
2%
Alanine aminotransferase increased
1%
Tinnitus
1%
Appendicitis
1%
Oral herpes
1%
Borrelia infection
1%
Actinic keratosis
1%
Drug hypersensitivity
1%
Weight increased
1%
Respiratory tract infection
1%
Epilepsy
1%
Dental caries
1%
Periodontal disease
1%
Typhoid fever
1%
Pyrexia
1%
Acne pustular
1%
Bacteriuria
1%
Conjunctivitis bacterial
1%
Gastroenteritis viral
1%
Gastrointestinal infection
1%
Hepatitis e
1%
Pharyngotonsillitis
1%
Pulpitis dental
1%
Hepatic enzyme increased
1%
Weight decreased
1%
Type 2 diabetes mellitus
1%
Osteoarthritis
1%
Spinal pain
1%
Migraine
1%
Rash
1%
Seborrhoeic dermatitis
1%
Tooth extraction
1%
Abdominal pain lower
1%
Injection site induration
1%
Injection site reaction
1%
Hypersensitivity
1%
Bacterial infection
1%
Postoperative wound infection
1%
Skin laceration
1%
Arthropathy
1%
Muscle spasms
1%
Upper-airway cough syndrome
1%
Dermal cyst
1%
Glomerulonephritis membranous
1%
Vertigo
1%
Injection site swelling
1%
Cholecystitis
1%
Cystitis
1%
Erythema migrans
1%
Folliculitis
1%
Molluscum contagiosum
1%
Arthropod bite
1%
Thermal burn
1%
Blood triglycerides increased
1%
Very low density lipoprotein increased
1%
Skin papilloma
1%
Herpes zoster
1%
Procedural pain
1%
Emphysema
100%
80%
60%
40%
20%
0%
Study treatment Arm
250 mg Miri Q4W Responder to 250 mg Miri Q8W
250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period
250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period
250 mg Miri Q4W Responders to 125 mg Miri Q8W
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mirikizumab Dose 3Experimental Treatment1 Intervention
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.
Group II: Mirikizumab Dose 2Experimental Treatment1 Intervention
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.
Group III: Mirikizumab Dose 1Experimental Treatment1 Intervention
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).
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
2,640 Previous Clinical Trials
3,221,554 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
418,000 Total Patients Enrolled
~60 spots leftby Jul 2027
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