Study Summary
This trial will help researchers learn more about how well inebilizumab works to prevent flare-ups in IgG4-related disease, and if it is safe to use.
Eligible Conditions
- IgG4-Related Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Day 1 to Day 2273
Day 2273
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Number of participants with Treatment Emergent Serious Adverse Events (TESAEs)
Day 365
Annualized flare rate for AC-determined treated flares
Annualized flare rate for AC-determined untreated flares
Annualized flare rate for Adjudication Committee (AC) determined flares
Annualized flare rate for treated flares
GC use for the purpose of IgG4-RD disease control
Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab
Proportion of participants achieving flare-free complete remission
Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and Adjudication Committee-determined IgG4 RD flare within the 52-week RCP.
Time to initiation of first treatment for new or worsening disease activity
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Inebilizumab/Inebilizumab
23%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%Fatigue
7%Bronchitis
7%Hypoaesthesia
7%Paraesthesia
6%Anaemia
6%Fall
6%Insomnia
6%Pain in extremity
5%Vomiting
5%Eye pain
5%Rhinitis
5%Constipation
5%Pyrexia
5%Depression
4%Dizziness
4%Pruritus
4%Rash
3%Cystitis
3%Conjunctivitis
3%Oral herpes
3%Muscle spasms
3%Myalgia
3%Alopecia
3%Hypertension
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%Pneumonia
2%Neutropenia
2%Influenza like illness
2%Neuromyelitis optica spectrum disorder
2%Dry eye
2%Abdominal pain
2%Gastritis
2%Muscular weakness
2%Eczema
2%Rhinorrhoea
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%Ileus
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%Crystal urine present
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%Peripheral nerve palsy
1%Appendicitis
1%Burns third degree
1%Connective tissue disorder
1%Myelitis transverse
1%Micturition urgency
1%Covid-19 pneumonia
1%Renal abscess
1%International normalised ratio increased
1%Optic neuritis
1%Calculus bladder
1%Deafness
1%Blindness unilateral
1%Atypical pneumonia
1%Cataract
1%Steroid withdrawal syndrome
1%Cholecystitis acute
1%Cholangitis acute
1%Covid-19
1%Cellulitis
1%Umbilical hernia
1%Chorioretinitis
1%Herpes zoster
1%Progressive multifocal leukoencephalopat
1%Bacteraemia
1%Central nervous system infection
1%Overdose
1%Colon cancer
1%Pneumonia bacterial
1%Foot fracture
1%Respiratory failure
1%Wrist fracture
1%Shock
1%Post cardiac arrest syndrome
1%Hypokalaemia
1%Hypotension
Trial Design
2 Treatment Groups
VIB0551
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
160 Total Participants · 2 Treatment Groups
Primary Treatment: Inebilizumab · Has Placebo Group · Phase 3
VIB0551
Drug
Experimental Group · 1 Intervention: Inebilizumab · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inebilizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 2273
Who is running the clinical trial?
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
838 Total Patients Enrolled
Viela BioLead Sponsor
12 Previous Clinical Trials
996 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics Ireland DAC
2,656 Previous Clinical Trials
7,957,243 Total Patients Enrolled
Nishi Rampal, MDStudy DirectorHorizon Therapeutics Ireland DAC
1 Previous Clinical Trials
270 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have IgG4-related disease that is affecting two or more organs or sites at any point during its course.
Frequently Asked Questions
Are there any patients who have yet to enroll in this research study?
"The latest information from clinicaltrials.gov reports that this study is still recruiting patients. The trial was first posted on October 26th, 2020 and updated most recently on October 19th, 2022." - Anonymous Online Contributor
Unverified Answer
To the best of your knowledge, has there been extensive research on Inebilizumab in the past?
"At this time, there are 3 clinical trials underway that focus on Inebilizumab. Out of those 3, 2 are currently in Phase 3. Most studies related to Inebilizumab's efficacy are located in Lille Cedex, Utah; however,217 different locations worldwide are running trials for this medication." - Anonymous Online Contributor
Unverified Answer
What is the current standing of Inebilizumab in regards to federal approval?
"Our analysts at Power have Inebilizumab's safety rated as a 3. This is based on the fact that this medication is in Phase 3 trials, where there is both efficacy and safety data from multiple rounds of testing." - Anonymous Online Contributor
Unverified Answer
How many patients are enrolled in this clinical trial?
"In order to carry out the planned research, a total of 160 eligible patients are needed. The trial will be conducted by Viela Bio (now owned by Horizon Therapeutics) at various sites; two examples being Viela Bio Investigative Site 1 in Palo Alto, California and Viela Bio Investigative Site 2 situated in Baltimore, Maryland." - Anonymous Online Contributor
Unverified Answer
Have there been previous studies like this one?
"Research for inebilizumab began in 2020 with the earliest study being sponsored by Viela Bio. After the first Phase 3 trial, which included 270 people, the drug was approved. Now, there are three active studies taking place in 28 countries and 48 cities." - Anonymous Online Contributor
Unverified Answer