Mirikizumab for Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MGH for Children - Waltham, Waltham, MA
Colitis+3 More
Mirikizumab - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether mirikizumab, a drug used to treat ulcerative colitis, is safe and effective in children.

See full description

Eligible Conditions

  • Colitis
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Mirikizumab will improve 1 primary outcome and 12 secondary outcomes in patients with Colitis. Measurement will happen over the course of Baseline through Week 52.

Baseline through Week 52
Pharmacokinetics (PK): Clearance of Mirikizumab
Baseline, Week 52
Change from baseline in 7-day average of Abdominal Pain Numeric Rating Scale (NRS) score at Week 12
Week 52
Change from Baseline in Body Weight
Height Velocity (in Centimeters/Year)
Percentage of Participants Who are in MMS Clinical Remission Without the Use of Corticosteroids
Percentage of Participants in Clinical Remission
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Percentage of Participants in Clinical Response
Percentage of Participants in Clinical Response Based on the PUCAI
Percentage of Participants in Endoscopic Remission
Percentage of Participants in Symptomatic Remission
Percentage of Participants who Entered the Study on Corticosteroids and who are in MMS Clinical Remission without the use of Corticosteroids
Percentage of Participants with Histologic-Endoscopic Mucosal Remission

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)
Gastrooesophageal reflux disease
0%
Haemorrhoids
0%
Periodontal disease
0%
Pain
0%
Cholelithiasis
0%
Borrelia infection
0%
Carbuncle
0%
Infected dermal cyst
0%
Nasopharyngitis
0%
Pneumonia
0%
Sinusitis
0%
Vulvovaginal candidiasis
0%
Blood creatine phosphokinase increased
0%
Blood uric acid increased
0%
Weight decreased
0%
Hyperuricaemia
0%
Overweight
0%
Arthritis
0%
Arthropathy
0%
Groin pain
0%
Vertigo
0%
Myalgia
0%
Rotator cuff syndrome
0%
Synovial cyst
0%
Nausea
0%
Dizziness
0%
Depression
0%
Emphysema
0%
Oropharyngeal pain
0%
Acne
0%
Blister
0%
Dermatitis psoriasiform
0%
Eczema
0%
Eczema asteatotic
0%
Perioral dermatitis
0%
Pruritus
0%
Wisdom teeth removal
0%
Haematoma
0%
Hypertension
0%
Vaginal infection
0%
Hypercholesterolaemia
0%
Dyspnoea
0%
Glossitis
0%
Toothache
0%
Fat necrosis
0%
Injection site pruritus
0%
Hypersensitivity
0%
Tinea versicolour
0%
Typhoid fever
0%
Contusion
0%
Electrocardiogram qt prolonged
0%
Lymphocyte count decreased
0%
Migraine
0%
Syncope
0%
Seborrhoeic dermatitis
0%
Cataract operation
0%
Amenorrhoea
0%
Pulmonary mass
0%
Duodenal sphincterotomy
0%
Back pain
0%
Palpitations
0%
Food poisoning
0%
Very low density lipoprotein increased
0%
Spinal osteoarthritis
0%
Goitre
0%
Cataract
0%
Hepatic enzyme increased
0%
Tonsillar hypertrophy
0%
Blood pressure increased
0%
Hypothyroidism
0%
Gastroenteritis
0%
Wound
0%
Conjunctival haemorrhage
0%
Parotitis
0%
Hyperglycaemia
0%
Cataract subcapsular
0%
Dental caries
0%
Gastritis
0%
Umbilical hernia
0%
Psoriatic arthropathy
0%
Hyperthermia
0%
Pyrexia
0%
Cholecystitis
0%
Drug-induced liver injury
0%
Allergy to arthropod bite
0%
Drug hypersensitivity
0%
Acute sinusitis
0%
Chronic sinusitis
0%
Conjunctivitis
0%
Ear infection
0%
Enterocolitis bacterial
0%
Erythema migrans
0%
Gastroenteritis viral
0%
Hepatitis a
0%
Influenza
0%
Pharyngitis streptococcal
0%
Pharyngotonsillitis
0%
Postoperative wound infection
0%
Rhinitis
0%
Dermatitis contact
0%
Tracheitis
0%
Arthropod bite
0%
Arthropod sting
0%
Epicondylitis
0%
Limb injury
0%
Procedural pain
0%
Skin abrasion
0%
Skin laceration
0%
Ear pain
0%
Thermal burn
0%
Fibrin d dimer increased
0%
Liver function test abnormal
0%
Cardiometabolic syndrome
0%
Diabetes mellitus
0%
Type 2 diabetes mellitus
0%
Bursitis
0%
Osteoarthritis
0%
Plantar fasciitis
0%
Tendonitis
0%
Cervical radiculopathy
0%
Headache
0%
Somnolence
0%
Insomnia
0%
Irritability
0%
Libido decreased
0%
Hydronephrosis
0%
Breast pain
0%
Menstruation irregular
0%
Vaginal discharge
0%
Rhinitis allergic
0%
Rhinorrhoea
0%
Upper respiratory tract inflammation
0%
Upper-airway cough syndrome
0%
Vocal cord polyp
0%
Actinic keratosis
0%
Alopecia areata
0%
Erythema
0%
Intertrigo
0%
Psoriasis
0%
Urticaria
0%
Blood pressure fluctuation
0%
Essential hypertension
0%
Gastrointestinal disorder
0%
Erysipelas
0%
Blood urea increased
0%
Enthesopathy
0%
Joint effusion
0%
Depressed mood
0%
Diffuse alopecia
0%
Tooth extraction
0%
Fall
0%
Skin fissures
0%
Abdominal pain
0%
Abdominal pain upper
0%
Diarrhoea
0%
Enteritis
0%
Chest pain
0%
Injection site reaction
0%
Oedema peripheral
0%
Bacterial infection
0%
Salpingo-oophoritis
0%
Upper respiratory tract infection
0%
Animal bite
0%
Foot fracture
0%
Post concussion syndrome
0%
Aspartate aminotransferase increased
0%
Blood glucose increased
0%
Blood triglycerides increased
0%
C-reactive protein increased
0%
Gamma-glutamyltransferase increased
0%
Heart rate increased
0%
Hepatitis b dna assay positive
0%
Liver function test increased
0%
Thyroxine free decreased
0%
Arthralgia
0%
Varicose vein
0%
Vomiting
0%
Hepatic steatosis
0%
Urethritis
0%
Meniscus injury
0%
Rib fracture
0%
Weight increased
0%
Dyslipidaemia
0%
Hypertriglyceridaemia
0%
Pain in extremity
0%
Basal cell carcinoma
0%
Facial paralysis
0%
Anxiety
0%
Dermal cyst
0%
Dyshidrotic eczema
0%
Abdominal pain lower
0%
Constipation
0%
Cellulitis
0%
Ligament rupture
0%
Ingrowing nail
0%
Malaise
0%
White blood cell count increased
0%
Aphthous ulcer
0%
Acute myocardial infarction
0%
Bradycardia
0%
Stomatitis
0%
Urinary tract infection
0%
Chronic gastritis
0%
Dry mouth
0%
Faeces soft
0%
Injection site erythema
0%
Injection site swelling
0%
Viral infection
0%
Spinal pain
0%
Arthritis bacterial
0%
Skull fracture
0%
Epilepsy
0%
Hepatitis e
0%
Bile duct stone
0%
Glomerulonephritis membranous
0%
Hilar lymphadenopathy
0%
Lymphadenopathy
0%
Subarachnoid haemorrhage
0%
Laryngitis
0%
Leukocytosis
0%
Pharyngitis
0%
Cerebral infarction
0%
Molluscum contagiosum
0%
Onychomycosis
0%
Otitis media acute
0%
Paronychia
0%
Pelvic inflammatory disease
0%
Periodontitis
0%
Thrombocytosis
0%
Ear discomfort
0%
Cardiac failure chronic
0%
Ocular hyperaemia
0%
Tonsillitis
0%
Tooth infection
0%
Helicobacter gastritis
0%
Blood cholesterol increased
0%
Alanine aminotransferase increased
0%
Hyperlipidaemia
0%
Costochondritis
0%
Fasciitis
0%
Intervertebral disc protrusion
0%
Joint swelling
0%
Muscle spasms
0%
Muscle tightness
0%
Muscular weakness
0%
Musculoskeletal chest pain
0%
Musculoskeletal pain
0%
Anogenital warts
0%
Dysplastic naevus
0%
Fibroma
0%
Skin papilloma
0%
Dysmenorrhoea
0%
Asthma
0%
Tobacco abuse
0%
Dysuria
0%
Nasal congestion
0%
Rash
0%
Rosacea
0%
Appendicitis
0%
Atrial fibrillation
0%
Injection site induration
0%
Injection site pain
0%
Tonsillectomy
0%
Tinnitus
0%
Blepharitis
0%
Vitreous floaters
0%
Visual impairment
0%
Defaecation disorder
0%
Dyspepsia
0%
Gingival atrophy
0%
Fatigue
0%
Influenza like illness
0%
Xerosis
0%
Abdominal wall abscess
0%
Acne pustular
0%
Body tinea
0%
Bacteriuria
0%
Bronchitis
0%
Cystitis
0%
Conjunctivitis bacterial
0%
Epididymitis
0%
Folliculitis
0%
Gastrointestinal infection
0%
Herpes zoster
0%
Hordeolum
0%
Oral herpes
0%
Otitis media
0%
Pulpitis dental
0%
Respiratory tract infection
0%
Tinea pedis
0%
Subcutaneous abscess
0%
Ankle fracture
0%
Ligament sprain
0%
Sciatica
0%
Sinus headache
0%
Wound complication
0%
Gout
0%
Increased appetite
0%
Lipoma
0%
Hypoaesthesia
0%
Sleep disorder
0%
Pollakiuria
0%
Erectile dysfunction
0%
Prostatitis
0%
Cough
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03482011) in the 250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders) ARM group. Side effects include: Gastrooesophageal reflux disease with 0%, Haemorrhoids with 0%, Periodontal disease with 0%, Pain with 0%, Cholelithiasis with 0%.

Trial Design

3 Treatment Groups

Mirikizumab Dose 2
1 of 3
Mirikizumab Dose 1
1 of 3
Mirikizumab Dose 3
1 of 3
Experimental Treatment

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. Mirikizumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Mirikizumab Dose 2
Drug
Mirikizumab administered IV and SC. Participants ≤40 kg
Mirikizumab Dose 1
Drug
Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)
Mirikizumab Dose 3
Drug
Mirikizumab administered IV and SC. Participants ≤40 kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 52 for reporting.

Closest Location

MGH for Children - Waltham - Waltham, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who take part in this study must have UC that is moderately to severely active, as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of the study treatment. show original
Participants with UC extending proximal to the rectum are required to provide evidence. show original
Weighing more than 10 kg, participants were included in the study. show original
People who want to take part in the study must have had ulcerative colitis for at least 3 months. show original
including tumor necrosis factor inhibitors (TNFis) People who don't respond to, lose response to, or can't tolerate corticosteroids, immunomodulators, JAK inhibitors, or biologic therapies for UC, including TNF inhibitors, are eligible to participate. show original

Patient Q&A Section

What causes ulcer?

"Ulcers are a major cause of morbidity and functional impairment in the elderly. There is no single cause (e.g. NSAID consumption) but a number of contributing factors (e.g. smoking, alcohol consumption) and this should also be considered when setting the goal to avoid ulcers in high-risk patients using topical and/or systemic treatment, or if prophylaxis is being contemplated." - Anonymous Online Contributor

Unverified Answer

What is ulcer?

"Nonsteroidal anti-inflammatory drugs (NSAIDs), when used in excess or in combination with other potentially damaging drugs, increase the risk of peptic ulcers, which in turn, are an increased risk factor of upper gastrointestinal bleeding (UGIB). NSAID can cause UGIB through a number of pathways. Firstly, by disrupting the protective mucosal barrier through the action of prostaglandins, NSAIDS cause mucosal bleeding from the underlying mucosa by altering mucosal blood flow, mucinaemia, edema and hyperemia (hyperaemic ulcer). This causes a defect that can be seen between the superficial mucosa, the submucosa and muscle layer of the mucosa (duodenal ulcers)." - Anonymous Online Contributor

Unverified Answer

How many people get ulcer a year in the United States?

"Most Americans have one or more uncomplicated, acute [ulcers] a year, and in the United States, the majority of patients with acute [ulcers] can be treated with a brief course of oral medications, or with a short course of bedrest. Ulcers are common in all age groups, and approximately 24.6 million new cases (2.6 percent of all cases) occurred in 2013. In 2013, the estimated incidence rate of uncomplicated and uncomplicated-complicated ulcers was 4.2 and 6.3 cases per 100,000 persons, respectively. Most cases of uncomplicated acute [ulcers] occurred in persons ages 50 to 69 years." - Anonymous Online Contributor

Unverified Answer

Can ulcer be cured?

"Most cases of painful oesophageal or duodenal ulcer can be cured, though not in all. For oesophageal ulcer, the presence of Barrett's oesophagus and Helicobacter pylori infection should be treated before ulceration develops. For duodenal ulcer, initial ulceration usually heals without surgery, and relapse usually occurs due to reflux disease. When surgery is required, most patients may be cured." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ulcer?

"Ulcer management guidelines have been validated for the use in the US. Ulcers are common in the outpatient clinic and are a common cause of outpatient department visit, but most referrals were made for treatment in the inpatient setting. Patients with chronic ulcers also have significant medical and social consequences, and are more likely to be treated with aggressive and costly medications." - Anonymous Online Contributor

Unverified Answer

What are the signs of ulcer?

"Uncomplained stomach pain is a reliable sign of ulcus. The presence of red patches or hemorrhages on abdominal examination is another strong sign of ulcus. Abdominal radiograph is the gold standard, and can be used to confirm the diagnosis. The presence of H. pylori infection should be considered to prevent recurrence of peptic ulcer when found to be negative on endoscopy." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets ulcer?

"Symptoms of acute lower GI complaints are significantly increased as people get older. This should not be mistaken for true ulcer, which appears to be rare." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for ulcer?

"Clinical trials may be an alternative or adjunct to medical therapy in GI-related medical disorders to support and aid therapy, to evaluate therapeutic outcome, or to compare therapeutic regimens." - Anonymous Online Contributor

Unverified Answer

Has mirikizumab proven to be more effective than a placebo?

"Mirikizumab was associated with significantly greater improvements in VAS scores, SF-36 QOL, and a significantly decreased relapse rate in MDE compared to a placebo. The difference in remission rate in MDE was more clinically relevant than the increase in SF-36 QOL in the placebo group. (Multicenter, double-blind, randomized, placebo-controlled trials NCT00991247 and NCT01432451). (http://www.clinicaltrials.gov)." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mirikizumab?

"Mirikizumab is generally well tolerated (as with other anti-IL-23 medicines in the recent past). The most common side effects were infection and infusion reactions. Mirikizumab shares some common side effects such as fatigue, infections, infusion reactions, and rash with tocilizumab." - Anonymous Online Contributor

Unverified Answer

Does mirikizumab improve quality of life for those with ulcer?

"Mirikizumab treatment resulted in improvements in pain, and HRQoL. Mirikizumab significantly improved QoL as opposed to placebo. Mirikizumab represents an important new treatment option for patients at risk for recurrence following ulcer-associated lower gastrointestinal bleeding." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of ulcer?

"We believe that ulcerations on the GI tract can be divided into three types: local, inflammatory, and inflammatory and neoplastic. Ulcerative colitis constitutes the most common GI mucosal inflammatory bowel disorder. Inflammatory and neoplastic pathogenesis are less common. Ulcerative colitis is the most clinically significant form of inflammation of the GI tract, and is generally considered a benign condition, with ulcers of the colon accounting for roughly 10% of cases. Ulcers in this context are usually encountered in patients with chronic colitis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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