← Back to Search

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
Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 2273
Awards & highlights

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.

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.Check my eligibility
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.See study design
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...
I am using effective birth control as I could get pregnant.
Select...
My IgG4-RD has affected at least two organs or sites.
Select...
I am a man who can father children and will use a condom with spermicide during the study and for 6 months after.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with IgG4-related disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 2273
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 2273 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
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
+8 more

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%
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

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

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,528 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
2020. "A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540497.
~36 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top