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Monoclonal Antibodies
Inebilizumab for Neuromyelitis Optica
Phase 2
Recruiting
Research Sponsored by Horizon Therapeutics Ireland DAC
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 baseline, week 1, week 2, week 28, week 80
Awards & highlights
Study Summary
This trial will study the effects of inebilizumab in children 2-18 years old with NMOSD who have AQP4-IgG antibodies.
Who is the study for?
This trial is for kids aged 2 to <18 with Neuromyelitis Optica Spectrum Disorder (NMOSD) who've had at least one relapse in the past year or two in the last two years. They must test positive for AQP4-IgG antibodies and meet specific diagnostic criteria. Kids can't join if they've recently taken certain meds, received live vaccines or blood transfusions, have uncontrolled autoimmune diseases, significant organ dysfunction, severe allergies to multiple drugs/foods, or low B-cell counts.Check my eligibility
What is being tested?
The study tests Inebilizumab's effects on children with NMOSD. It's an open-label Phase 2 trial where all participants receive the drug; researchers will look at how it moves through and affects the body (PK/PD), as well as its safety profile.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of Inebilizumab may include infusion reactions like fever and chills, infections due to immune system suppression, liver enzyme elevations indicating possible liver damage, and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, week 2, week 28, week 80
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 28, week 80
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Concentration Versus Time Curve of inebilizumab from Time 0 extrapolated to infinity (AUC0-Inf)
Area Under the Concentration Versus Time Curve of inebilizumab from Time 0 to 14 days post-dose (AUC0-14d)
Change from Baseline in Body Temperature
+13 moreSecondary outcome measures
Anti-drug antibody (ADA) rate.
Disease Activity: Annualized relapse rate.
Disease Activity: Proportion of relapse-free subjects.
+5 moreSide effects data
From 2020 Phase 2 & 3 trial • 231 Patients • NCT0220077023%
Urinary tract infection
22%
Nasopharyngitis
18%
Headache
16%
Upper respiratory tract infection
16%
Arthralgia
14%
Back pain
13%
Infusion related reaction
10%
Influenza
10%
Cough
9%
Diarrhoea
9%
Nausea
7%
Bronchitis
7%
Paraesthesia
7%
Hypoaesthesia
7%
Fatigue
6%
Fall
6%
Insomnia
6%
Pain in extremity
6%
Anaemia
5%
Depression
5%
Rhinitis
5%
Constipation
5%
Pyrexia
5%
Eye pain
5%
Vomiting
4%
Dizziness
4%
Pruritus
4%
Rash
3%
Alopecia
3%
Conjunctivitis
3%
Oral herpes
3%
Cystitis
3%
Muscle spasms
3%
Myalgia
3%
Hypertension
2%
Neuromyelitis optica spectrum disorder
2%
Rhinorrhoea
2%
Lymphopenia
2%
Hordeolum
2%
Peripheral swelling
2%
Respiratory tract infection viral
2%
Sinusitis
2%
Dysaesthesia
2%
Musculoskeletal pain
2%
Neck pain
2%
Nocturia
2%
Oropharyngeal pain
2%
Neutropenia
2%
Gastritis
2%
Muscular weakness
2%
Eczema
2%
Pneumonia
2%
Dry eye
2%
Abdominal pain
2%
Influenza like illness
1%
Post cardiac arrest syndrome
1%
Atypical pneumonia
1%
Hypokalaemia
1%
Crystal urine present
1%
Covid-19
1%
Chorioretinitis
1%
Central nervous system infection
1%
Cellulitis
1%
Herpes zoster
1%
Covid-19 pneumonia
1%
Ileus
1%
Cholecystitis acute
1%
Umbilical hernia
1%
Connective tissue disorder
1%
Cholangitis acute
1%
Respiratory failure
1%
Bacteraemia
1%
Overdose
1%
Calculus bladder
1%
Renal abscess
1%
Eye pruritus
1%
Facial pain
1%
Gait disturbance
1%
Dry mouth
1%
Vision blurred
1%
Abdominal discomfort
1%
Pancreatitis acute
1%
Adrenal insufficiency
1%
Abdominal pain lower
1%
Hepatic steatosis
1%
Eye irritation
1%
Enteritis
1%
Enterocolitis
1%
Chills
1%
Hyperthyroidism
1%
Vertigo
1%
Abdominal pain upper
1%
Dyspepsia
1%
Irritable bowel syndrome
1%
Chest discomfort
1%
Ear pain
1%
Non-cardiac chest pain
1%
Dental caries
1%
Sensitivity of teeth
1%
Drug intolerance
1%
Eye inflammation
1%
Discomfort
1%
Hepatic function abnormal
1%
Muscle abscess
1%
Seasonal allergy
1%
Bacterial vaginosis
1%
Toothache
1%
Pain
1%
Asthenia
1%
Malaise
1%
Abscess limb
1%
Breast abscess
1%
Oedema peripheral
1%
Gastroenteritis viral
1%
Rash pustular
1%
Periodontitis
1%
Conjunctivitis viral
1%
Fungal skin infection
1%
Blood glucose fluctuation
1%
Bacteriuria
1%
Paronychia
1%
Beta haemolytic streptococcal infection
1%
Pharyngitis
1%
Pharyngitis streptococcal
1%
Tracheitis
1%
Gingivitis
1%
Viral rhinitis
1%
Arthropod bite
1%
Femur fracture
1%
Ligament injury
1%
Laryngitis
1%
Respiratory tract infection
1%
Tinea cruris
1%
Viral infection
1%
Blood cholesterol increased
1%
Otitis externa
1%
Eye contusion
1%
Retinitis
1%
Soft tissue infection
1%
Viral pharyngitis
1%
Laceration
1%
Ligament sprain
1%
Salpingitis
1%
Urinary tract infection staphylococcal
1%
Viral upper respiratory tract infection
1%
Post-traumatic pain
1%
Groin pain
1%
Muscle spasticity
1%
Bacterial test positive
1%
Lymphocyte count decreased
1%
Arthritis
1%
Bone deformity
1%
Intercostal neuralgia
1%
Abnormal dreams
1%
Nuclear magnetic resonance imaging abnormal
1%
Road traffic accident
1%
Gamma-glutamyltransferase increased
1%
Alanine aminotransferase increased
1%
Blood folate decreased
1%
Eosinophil percentage increased
1%
Neutrophil count increased
1%
Cognitive disorder
1%
Benign prostatic hyperplasia
1%
Weight decreased
1%
White blood cell count increased
1%
Hypertriglyceridaemia
1%
Flank pain
1%
Limb discomfort
1%
Ligament laxity
1%
Spinal pain
1%
Balance disorder
1%
Myasthenia gravis
1%
Facial paralysis
1%
Yawning
1%
Dry skin
1%
Hyperlipidaemia
1%
Migraine with aura
1%
Restlessness
1%
Menorrhagia
1%
Chronic obstructive pulmonary disease
1%
Blister
1%
Coccydynia
1%
Musculoskeletal stiffness
1%
Allodynia
1%
Hypokinesia
1%
Migraine
1%
Hypercholesterolaemia
1%
Tendon pain
1%
Pituitary tumour benign
1%
Menstrual disorder
1%
Epilepsy
1%
Hypersomnia
1%
Monoparesis
1%
Depressed mood
1%
Asthma
1%
Erythema
1%
Night sweats
1%
Hiccups
1%
Acne
1%
Drug eruption
1%
Hidradenitis
1%
Tooth extraction
1%
Hyperhidrosis
1%
Psoriasis
1%
Rash maculo-papular
1%
Skin hyperpigmentation
1%
Miliaria
1%
Onychoclasis
1%
Skin exfoliation
1%
Urticaria
1%
Leukopenia
1%
Myelitis
1%
Tinnitus
1%
Arrhythmia
1%
Neutrophilia
1%
Ear pruritus
1%
Leukocytosis
1%
Skin abrasion
1%
Procedural nausea
1%
Body temperature increased
1%
Liver function test increased
1%
Adjustment disorder with depressed mood
1%
Anxiety
1%
Leukocyturia
1%
Fibrocystic breast disease
1%
Tension headache
1%
Somnolence
1%
Post-traumatic headache
1%
Syncope
1%
Tremor
1%
Benign ovarian tumour
1%
International normalised ratio increased
1%
Optic neuritis
1%
Peripheral nerve palsy
1%
Deafness
1%
Appendicitis
1%
Steroid withdrawal syndrome
1%
Blindness unilateral
1%
Cataract
1%
Micturition urgency
1%
Hypotension
1%
Pneumonia bacterial
1%
Progressive multifocal leukoencephalopat
1%
Burns third degree
1%
Foot fracture
1%
Wrist fracture
1%
Colon cancer
1%
Myelitis transverse
1%
Shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inebilizumab/Inebilizumab
Placebo/Inebilizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: InebilizumabExperimental Treatment1 Intervention
Infusion of Inebilizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inebilizumab
2015
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,461 Total Patients Enrolled
3 Trials studying Neuromyelitis Optica Spectrum Disorders
123 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Nishi RampalStudy DirectorHorizon Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have NMOSD and tested positive for anti-AQP4-IgG.I am between 2 and 17 years old.I haven't had specific immune treatments or a bone marrow transplant before starting this trial.My blood tests show I don't have liver, kidney, or metabolic issues and my B-cell counts are normal.I have had at least one NMOSD flare-up in the past year or two in the last two years.I tested positive for anti-AQP4 and have been diagnosed with NMOSD.I am between 2 and 17 years old.I have had at least one NMOSD flare-up in the past year or two in the last two years.
Research Study Groups:
This trial has the following groups:- Group 1: Inebilizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to partake in this investigation?
"The requirements to be accepted into this clinical trial are specific; potential participants must have neuromyelitis optica and fall between the ages of 2 and 17. The maximum capacity for enrolment is 15 individuals."
Answered by AI
Does this research encompass participants older than two decades in age?
"This medical trial is seeking participants aged between 2 and 17 years old."
Answered by AI
Is Inebilizumab considered a risk-free treatment option for patients?
"Preclinical research indicates that Inebilizumab is reasonably safe, thus warranting a score of 2. Despite this safety evidence, no clinical studies have been conducted to measure the efficacy of this drug."
Answered by AI
Is the recruitment phase of this research still ongoing?
"Affirmative. According to clinicaltrials.gov, this medical experiment was posted on August 25th 2022 and is still currently recruiting participants; 15 patients are needed at 4 distinct sites."
Answered by AI
How many individuals are partaking in this medical study?
"All in all, 15 compliant participants are necessary to keep the trial running. Horizon Therapeutics Ireland DAC will be managing it from several different sites including University of Texas Southwestern Medical Centre and Massachusetts General Hospital respectively located in Dallas and Lexington."
Answered by AI
Are there extensive facilities that are presently conducting research with this study in North America?
"This study is being conducted at 4 separate medical institutions, such as the University of Texas Southwestern Medical Center in Dallas and Massachusetts General Hospital in Lexington. Additionally, UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Building in La Jolla has also been enlisted along with other centres."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Building
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
New York
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Building: < 24 hours
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