Intravenous dose of obinutuzumab for Microscopic Polyangiitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pennsylvania, Philadelphia, PA
Microscopic Polyangiitis+6 More
Obinutuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).

Eligible Conditions

  • Microscopic Polyangiitis
  • Wegeners Granulomatosis (Granulomatosis With Polyangiitis)
  • ANCA-Associated Vasculitis (AAV)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 18 months

12 months
Number of patients to achieve sustained complete remission 12 months
18 months
Number of patients to achieve sustained complete remission 18 months
6 months
Number of patients to achieve both complete remission and seronegativity for ANCA.
Number of patients to achieve sustained complete remission 6 months

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

IBR+OB
44%Neutropenia
35%Thrombocytopenia
35%Diarrhea
29%Cough
24%Arthralgia
23%Infusion related reaction
19%Fatigue
19%Back pain
19%Hypertension
17%Pyrexia
17%Anaemia
17%Constipation
16%Upper respiratory tract infection
15%Rash maculo-papular
14%Atrial fibrillation
14%Muscle spasms
13%Nasopharyngitis
13%Nausea
13%Hyperuricaemia
12%Oedema peripheral
12%Urinary tract infection
12%Insomnia
11%Conjunctivitis
11%Vomiting
11%Asthenia
11%Pneumonia
11%Pain in extremity
11%Dizziness
11%Dyspnoea
10%Cataract
10%Decreased appetite
9%Spontaneous haematoma
9%Fall
9%Anxiety
9%Rash
8%Headache
8%Dyspepsia
8%Vision blurred
8%Abdominal pain
8%Iron deficiency
8%Pruritus
7%Bronchitis
7%Gastrooesophageal reflux disease
7%Lacrimation increased
7%Blood creatine increased
7%Respiratory tract infection
7%Productive cough
7%Oropharyngeal pain
6%Peripheral swelling
6%Palpitations
6%Dry eye
6%Stomatitis
6%Chills
6%Hypokalaemia
6%Depression
6%Epistaxis
6%Myalgia
6%Ecchymosis
6%Dry Skin
6%Onychoclasis
5%Herpes zoster
5%Contusion
5%Hyperglycaemia
5%Haematuria
5%Petechiae
5%Cellulitis
5%Musculoskeletal pain
5%Increased tendency to bruise
4%Febrile neutropenia
4%Tremor
3%Acute coronary syndrome
3%Gastroenteritis
3%Weight decreased
3%Adenocarcinoma of colon
2%Transient ischaemic attack
2%Cerebrovascular accident
2%Renal failure
2%Angina pectoris
2%Cardiac arrest
2%Septic shock
2%Acute kidney injury
2%Death
2%Femur fracture
2%Osteoarthritis
1%Pubis fracture
1%Inclusion body myositis
1%Escherichia urinary tract infection
1%Incisional hernia
1%Diabetes mellitus inadequate control
1%Listeria sepsis
1%Invasive ductal breast carcinoma
1%Traumatic haematoma
1%Upper limb fracture
1%Osteoma
1%Arthritis
1%Squamous cell carcinoma
1%Cerebral ischaemia
1%Confusional state
1%Pleural effusion
1%Benign prostatic hyperplasia
1%Haemoptysis
1%Hypotension
1%Pneumonia klebsiella
1%Myocardial infarction
1%Leukopenia
1%Acute myocardial infarction
1%Atrial tachycardia
1%Stress cardiomyopathy
1%Cardiac failure congestive
1%Pericarditis
1%Cholelithiasis
1%Oesophageal rupture
1%Retinal detachment
1%Haemorrhoids
1%Inguinal hernia
1%Abscess
1%Small intestinal obstruction
1%Sudden Death
1%Catheter site haematoma
1%Bursitis infective staphylococcal
1%Escherichia sepsis
1%Proctitis
1%Infective aneurysm
1%Multi-organ disorder
1%Bacterial sepsis
1%Bronchopulmonary aspergillosis
1%Herpes Zoster
1%Prostate infection
1%Erysipelas
1%Streptococcal bacteraemia
1%Urosepsis
1%Pneumocystis jirovecii pneumonia
1%Pharyngitis
1%Pneumonia bacterial
1%Sinusitis fungal
1%Compartment syndrome
1%Soft tissue infection
1%Spinal compression fracture
1%Hypercalcaemia
1%Thoracic vertebral fracture
1%Rib fracture
1%Adenocarcinoma gastric
1%Basal cell carcinoma
1%Colorectal cancer
1%Ischaemic stroke
1%Colorectal cancer metastatic
1%Malignant melanoma
1%Benign renal neoplasm
1%Myelodysplastic syndrome
1%Depressed level of consciousness
1%Non-small cell lung cancer
1%Syncope
1%Complete Suicide
1%Acute psychosis
1%Nephrolithiasis
1%Urinary retention
1%Bronchitis chronic
1%Uterine prolapse
1%Peripheral ischaemia
1%Respiratory failure
1%Oral herpes
1%Goitre
1%Cardiac failure
1%Aplastic anaemia
1%Large intestine polyp
1%Gastritis
1%Impaired gastric emptying
1%Lower respiratory tract infection
1%Jaw fracture
1%Concussion
1%Hypomagnesaemia
0%Essential thrombocythaemia
0%Kaposi's sarcoma
0%Hyponatraemia
0%Keratoacanthoma
0%Loss of consciousness
0%Pericarditis constrictive
0%Cholecystitis
0%Sepsis
0%Accidental overdose
0%Craniocerebral injury
0%Dehydration
0%Tumour lysis syndrome
0%Osteolysis
0%Chronic lymphocytic leukaemia
0%Prostate Cancer
0%Neuroendocrine carcinoma of the skin
0%Seizure
0%Acute respiratory failure
0%Venous thrombosis limb
0%Pulmonary embolism
0%Myocardial ischaemia
0%Hip fracture
0%Vascular device infection
0%Osteonecrosis of jaw
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02264574) in the IBR+OB ARM group. Side effects include: Neutropenia with 44%, Thrombocytopenia with 35%, Diarrhea with 35%, Cough with 29%, Arthralgia with 24%.

Trial Design

2 Treatment Groups

Intravenous dose of rituximab
1 of 2
Intravenous dose of obinutuzumab
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Intravenous dose of obinutuzumab · No Placebo Group · Phase 2

Intravenous dose of obinutuzumab
Drug
Experimental Group · 1 Intervention: Obinutuzumab · Intervention Types: Drug
Intravenous dose of rituximab
Drug
ActiveComparator Group · 1 Intervention: Rituximab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2013
Completed Phase 3
~3200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Trial Background

Ulrich Specks, MD
Principal Investigator
Mayo Clinic
Closest Location: University of Pennsylvania · Philadelphia, PA
Photo of Hospital of the University of Pennsylvania  1Photo of Hospital of the University of Pennsylvania  2Photo of University of Pennsylvania  3
2011First Recorded Clinical Trial
12 TrialsResearching Microscopic Polyangiitis
1048 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have severe newly-diagnosed disease or severe relapsing disease.
Patients must have B cells detectable in the peripheral blood.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.