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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
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 2273
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 2273
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 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
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
1,383 Previous Clinical Trials
1,379,786 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely reduced.I need steroids for my IgG4-related disease flare-up.I am using effective birth control as I could get pregnant.My IgG4-RD has affected at least two organs or sites.I haven't taken non-biologic DMARDs or immunosuppressants, except for GCs, in the last 4 weeks.I haven't had an active cancer except for certain types of cervical, skin, or prostate cancer in the last 10 years.I have not received a live vaccine or therapy with live agents in the last 2 weeks.I am a man who can father children and will use a condom with spermicide during the study and for 6 months after.I do not have active tuberculosis, hepatitis B, or untreated hepatitis C.I am 18 years old or older.I have been diagnosed with IgG4-related disease.I have had an organ transplant or have an immunodeficiency disorder.I haven't had B cell therapy in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: VIB0551
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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