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Monoclonal Antibodies

Inebilizumab for IgG4-Related Disease

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent
IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
Must not have
Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial tests if inebilizumab, an IV medication, can prevent flare-ups in patients with IgG4-RD who are at high risk. It works by reducing immune cells that cause inflammation and damage.

Who is the study for?
Adults over 18 with IgG4-Related Disease affecting at least two organs and needing glucocorticoid treatment can join. They must meet specific criteria, use effective contraception if of childbearing potential, and not have used certain drugs or had live vaccines recently. Those with recent malignancies or severe kidney issues are excluded.
What is being tested?
The trial is testing Inebilizumab's ability to prevent flares in IgG4-Related Disease compared to a placebo. Participants will be randomly assigned to receive either the drug or a placebo to assess effectiveness and safety.
What are the potential side effects?
While the side effects for Inebilizumab aren't specified here, similar medications may cause infusion reactions, infections due to immune system suppression, allergic responses, and possible impact on liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need steroids for my IgG4-related disease flare-up.
Select...
My IgG4-RD has affected at least two organs or sites.
Select...
I have been diagnosed with IgG4-related disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney function is severely reduced.
Select...
I haven't taken non-biologic DMARDs or immunosuppressants, except for GCs, in the last 4 weeks.
Select...
I do not have active tuberculosis, hepatitis B, or untreated hepatitis C.
Select...
I have had an organ transplant or have an immunodeficiency disorder.
Select...
I haven't had B cell therapy in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 & 3 trial • 231 Patients • NCT02200770
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%
Paraesthesia
7%
Bronchitis
7%
Hypoaesthesia
7%
Fatigue
6%
Fall
6%
Insomnia
6%
Pain in extremity
6%
Anaemia
5%
Depression
5%
Constipation
5%
Pyrexia
5%
Rhinitis
5%
Eye pain
5%
Vomiting
4%
Dizziness
4%
Pruritus
4%
Rash
3%
Muscle spasms
3%
Cystitis
3%
Conjunctivitis
3%
Oral herpes
3%
Alopecia
3%
Myalgia
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%
Neutropenia
2%
Neuromyelitis optica spectrum disorder
2%
Gastritis
2%
Rhinorrhoea
2%
Muscular weakness
2%
Eczema
2%
Pneumonia
2%
Dry eye
2%
Abdominal pain
2%
Influenza like illness
1%
Crystal urine present
1%
Hypokalaemia
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%
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%
Covid-19 pneumonia
1%
Renal abscess
1%
Calculus bladder
1%
Umbilical hernia
1%
Cholangitis acute
1%
Cholecystitis acute
1%
Atypical pneumonia
1%
Bacteraemia
1%
Covid-19
1%
Cellulitis
1%
Central nervous system infection
1%
Chorioretinitis
1%
Herpes zoster
1%
Overdose
1%
Connective tissue disorder
1%
Post cardiac arrest syndrome
1%
Respiratory failure
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
Placebo/Inebilizumab
Inebilizumab/Inebilizumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB0551Experimental Treatment1 Intervention
Inebilizumab administered as an IV infusion.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered as an IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inebilizumab
2015
Completed Phase 3
~240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for IgG4-Related Disease, such as inebilizumab, work by depleting B cells through targeting CD19. B cells are a type of white blood cell that can produce antibodies, including those involved in autoimmune responses. By depleting B cells, these treatments reduce the production of harmful antibodies, thereby decreasing inflammation and preventing disease flares. This mechanism is crucial for patients with IgG4-Related Disease as it directly addresses the underlying immune dysfunction, leading to better disease control and improved quality of life.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,609 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
811 Total Patients Enrolled
Viela BioLead Sponsor
12 Previous Clinical Trials
969 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,365 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics Ireland DAC
2,900 Previous Clinical Trials
8,090,299 Total Patients Enrolled
Nishi Rampal, MDStudy DirectorHorizon Therapeutics Ireland DAC
1 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

Inebilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04540497 — Phase 3
Related Disease Research Study Groups: VIB0551, Placebo
Related Disease Clinical Trial 2023: Inebilizumab Highlights & Side Effects. Trial Name: NCT04540497 — Phase 3
Inebilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540497 — Phase 3
~27 spots leftby Dec 2025
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