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Monoclonal Antibodies
Obinutuzumab for Granulomatosis with Polyangiitis
Phase 2
Waitlist Available
Led By Ulrich Specks, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positivity for ANCA, directed against proteinase-3 (PR3)
Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic polyangiitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will test if obinutuzumab is an effective and safe treatment for people with PR3-AAV.
Who is the study for?
This trial is for adults with ANCA-associated vasculitis, specifically PR3-AAV. Participants must have a certain level of disease severity and be vaccinated against COVID-19. Women who can bear children and men with partners who can must use contraception. Exclusions include severe allergies to monoclonal antibodies, recent live vaccines, active infections (including hepatitis B/C or HIV), uncontrolled diseases that could affect the trial's outcome, history of certain malignancies within 5 years, and intolerance to rituximab.Check my eligibility
What is being tested?
The PRRR study tests obinutuzumab's effectiveness and safety in treating PR3-AAV compared to rituximab. It aims to see if obinutuzumab can induce longer remission periods in patients with this type of vasculitis by targeting immune cells involved in the disease process.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to infusion, increased risk of infections due to immune system suppression, possible blood disorders like low white cell counts which increase infection risks further, liver enzyme elevations indicating potential liver issues, and general symptoms such as fatigue or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood test is positive for ANCA against PR3.
Select...
I have been diagnosed with a specific type of vasculitis (GPA or MPA).
Select...
I agree to use birth control for 18 months (if female) or 180 days (if male) after my last treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients to achieve both complete remission and seronegativity for ANCA.
Secondary outcome measures
Number of patients to achieve sustained complete remission 12 months
Number of patients to achieve sustained complete remission 18 months
Number of patients to achieve sustained complete remission 6 months
Side effects data
From 2019 Phase 3 trial • 229 Patients • NCT0226457444%
Neutropenia
35%
Thrombocytopenia
35%
Diarrhea
29%
Cough
24%
Arthralgia
23%
Infusion related reaction
19%
Fatigue
19%
Back pain
19%
Hypertension
17%
Anaemia
17%
Constipation
17%
Pyrexia
16%
Upper respiratory tract infection
15%
Rash maculo-papular
14%
Muscle spasms
14%
Atrial fibrillation
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Dyspnoea
11%
Vomiting
11%
Pain in extremity
11%
Dizziness
10%
Cataract
10%
Decreased appetite
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Adenocarcinoma of colon
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Acute myocardial infarction
1%
Myelodysplastic syndrome
1%
Haemoptysis
1%
Inclusion body myositis
1%
Uterine prolapse
1%
Colorectal cancer
1%
Non-small cell lung cancer
1%
Arthritis
1%
Leukopenia
1%
Compartment syndrome
1%
Bronchitis chronic
1%
Colorectal cancer metastatic
1%
Ischaemic stroke
1%
Bronchopulmonary aspergillosis
1%
Respiratory failure
1%
Invasive ductal breast carcinoma
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Concussion
1%
Malignant melanoma
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous dose of obinutuzumabExperimental Treatment1 Intervention
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of obinutuzumab
Group II: Intravenous dose of rituximabActive Control1 Intervention
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,025 Total Patients Enrolled
3 Trials studying Vasculitis
405 Patients Enrolled for Vasculitis
Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,743 Total Patients Enrolled
4 Trials studying Vasculitis
214 Patients Enrolled for Vasculitis
Ulrich Specks, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
197 Total Patients Enrolled
1 Trials studying Vasculitis
197 Patients Enrolled for Vasculitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood test is positive for ANCA against PR3.I have had a bad reaction to rituximab or similar medications.I have been diagnosed with a specific type of vasculitis (GPA or MPA).I use NSAIDs like ibuprofen daily.I am using two forms of birth control or practicing abstinence.I have undergone plasma exchange in the last 3 months.You have been diagnosed with human anti-chimeric antibodies (HACA) formation.I currently have an active COVID-19 infection.My vasculitis is not severe and does not require intense treatment.I do not have an active infection.I do not have active hepatitis B or C, and no history of HIV, hepatitis B, or C.I am fully vaccinated against COVID-19 and have a positive antibody test, or I have recovered from COVID-19 with a positive antibody test.I have had a serious infection like bone infection or lung abscess in the last 6 months.I have a history of getting infections often.Your liver or pancreas enzymes are more than 2.5 times the normal levels, unless it's due to a specific medical condition called vasculitis.I am premenopausal and either pregnant, breastfeeding, or not using birth control.Your disease activity score needs to be at least 3.I have had cancer in the past 5 years, but it was not skin or early cervical cancer treated with surgery.My blood tests show low white cells, hemoglobin, or platelets.I have been diagnosed with eosinophilic granulomatosis with polyangiitis.I agree to use birth control for 18 months (if female) or 180 days (if male) after my last treatment.I have a history of anti-GBM disease.I have not received a live vaccine in the last 4 weeks.You have had serious allergic reactions to certain types of medications made from proteins.You have a positive blood test for ANCA antibodies targeting myeloperoxidase.You have uncontrolled mental health issues or problems with drugs or alcohol that could affect your ability to take part in the trial.I am a woman who can still have children and have not been surgically sterilized or gone through menopause.My condition is severe, either newly diagnosed or worsening again, needing strong treatment.If you have had the disease come back, there must be a certain type of white blood cell in your blood.I need more than 10 mg of prednisone daily for a condition like asthma or IBD.My liver disease is severe and may affect my trial participation.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous dose of rituximab
- Group 2: Intravenous dose of obinutuzumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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