Granulomatosis With PolyangiitisPhase 2NCT05376319
PR3-AAV Resilient Remission or PRRR
A Phase 2 study testing Obinutuzumab and Rituximab in people with Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Mayo Clinic at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis, ANCA Associated Vasculitis
- What is being tested?
- Obinutuzumab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2023to 7 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic polyangiitis).
- Positivity for ANCA, directed against proteinase-3 (PR3)
- Severe newly-diagnosed disease or severe relapsing disease. Severe relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
- Minimum BVAS/WG of 3
- Relapsing patients must have B cells detectable in the peripheral blood.
- Patients must have completed COVID19 vaccination (including booster if eligible) at least 4 weeks prior to enrollment with a positive spike protein antibody test result. Patients who have recovered from COVID19 prior to screening with a positive spike protein antibody test result but have not been vaccinated are also eligible.
Show all 9Show fewer
- Female subjects of childbearing potential who are not sterile must agree to use an acceptable method of contraception for 18 months after the last dose of infusion medication. Male subjects who are not sterile whose female partners are of childbearing potential must agree to use an acceptable method of contraception for 180 days after the last dose of infusion medication.
- Females of childbearing potential include any female who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (to be considered postmenopausal, the patient must have had amenorrhea for >12 consecutive months).
- Acceptable methods of contraception include the use of at least two of the following: 1) intrauterine device; 2) hormonal contraceptives for at least 30 days prior to first dose infusion (oral, injectable, implant or ring); 3) barrier contraceptives (condom or diaphragm) with spermicide; or 4) abstinence.
Who cannot join
- Diagnosis with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) as defined by the Chapel Hill Consensus Conference.
- Positive serum assays for ANCA directed against myeloperoxidase (MPO-ANCA)
- Non-severe AAV, defined as disease that does not justify treatment with both B cell depletion and a four-month glucocorticoid taper.
- Any of the co-morbidities:
- Allergies: a history of severe allergic reactions to human or chimeric monoclonal antibodies or murine protein.
- Infection (systemic): an active systemic infection at screening visit
Show all 27Show fewer
- Infection (deep space): have been diagnosed as having a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by empyema or lung abscesses, within 6 months prior to the screening visit
- Infection (blood borne): active hepatitis B or active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C
- Infection (history): History of recurrent significant infection or history of recurrent bacterial infections
- Liver disease: acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial.
- Renal disease: a history of documented anti-glomerular basement membrane disease (anti-GBM disease).
- Malignancy: Active or history of malignancy in the last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment.
- Active COVID-19 infection.
- Uncontrolled disease: evidence of glucocorticoid dependent disease (such as asthma, COPD, psoriasis or IBD, etc.) requiring consistently greater than 10 mg of prednisone for disease control which might affect endpoint assessment or,
- Other uncontrolled diseases, including any uncontrolled psychiatric disorders, drug and alcohol abuse, that could interfere with participation in the trial according to the protocol.
- Diagnosis of human anti-chimeric antibodies (HACA) formation.
- Subjects who are premenopausal and are:
- Pregnant on the basis of a serum pregnancy test,
- Breastfeeding, or
- Do not agree to use effective method(s) of contraception
- Use of prohibited medications: They have used any of the prohibited medication listed in Section 5.9.1.
- Plasma exchange: They have been treated with plasma exchange within the 3 months preceding the screening visit.
- History of intolerance to rituximab or other chimeric monoclonal antibodies (e.g., infliximab).
- Recent vaccination: They have had a live vaccine fewer than 4 weeks (28 days) before or during randomization (vaccination with live vaccine through the end of study participation is contraindicated).
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Bone marrow suppression as evidenced by a total white count < 4 x10 /l, hemoglobin < 7 gm/dl or platelet count < 100,000/μl
- Aspartate aminotransferase or alanine aminotransferase or amylase > 2.5 times the upper limit of normal, unless attributed to vasculitis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab Versus Rituximab in PR3-Patients With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
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).
- Being tested
- Obinutuzumab, Rituximab
- Keywords
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, PR3-ANCA, ANCA-associated Vasculitis
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
RituximabDrug
1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dose of obinutuzumab | Experimental | Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of obinutuzumab Receives: Drug: Obinutuzumab |
| Intravenous dose of rituximab | Active comparator | Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of rituximab Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA.
Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper. Seronegativity for ANCA is defined as a negative test for antibodies directed against serine proteinase 3 (i.e., a negative PR3-ANCA assay).
Measured: 6 months
Secondary outcomes (3)
Number of Patients to Achieve Sustained Complete Remission 6 Months
Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper.
Measured: 6 months
Number of Patients to Achieve Sustained Complete Remission 12 Months
Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper.
Measured: 12 months
Number of Patients to Achieve Sustained Complete Remission 18 Months
Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start30 Jun 2023
- Primary completion7 May 2024
- Study completion7 May 2024
Why it stopped: Funding was withdrawn by sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Ulrich Specks, MD, Mayo Clinic
- Investigators
- Ulrich Specks, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376319
- Sponsor's protocol ID
- 21-012197
- Status last verified
- Apr 2026
- First submitted
- 11 May 2022
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effect of Obinutuzumab Versus Rituximab in PR3-Patients With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- ClinicalTrials.gov ID
- NCT05376319
- Acronym / sponsor ID
- 21-012197
- Keywords
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, PR3-ANCA, ANCA-associated Vasculitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was withdrawn by sponsor.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous dose of obinutuzumab | Experimental | Drug: ObinutuzumabSubjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of obinutuzumab |
| Intravenous dose of rituximab | Active comparator | Drug: RituximabSubjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic polyangiitis).
- Positivity for ANCA, directed against proteinase-3 (PR3)
- Severe newly-diagnosed disease or severe relapsing disease. Severe relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
- Minimum BVAS/WG of 3
- Relapsing patients must have B cells detectable in the peripheral blood.
Key exclusion criteria (27 listed)
- Diagnosis with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) as defined by the Chapel Hill Consensus Conference.
- Positive serum assays for ANCA directed against myeloperoxidase (MPO-ANCA)
- Non-severe AAV, defined as disease that does not justify treatment with both B cell depletion and a four-month glucocorticoid taper.
- Any of the co-morbidities:
- Diagnosis of human anti-chimeric antibodies (HACA) formation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obinutuzumab1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15 | Drug | Intravenous dose of obinutuzumab |
| Rituximab1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15 | Drug | Intravenous dose of rituximab |
Primary outcome
Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA.
Time frame: 6 months
Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper. Seronegativity for ANCA is defined as a negative test for antibodies directed against serine proteinase 3 (i.e., a negative PR3-ANCA assay).
3 secondary outcomes
Number of Patients to Achieve Sustained Complete Remission 6 Months
Time frame: 6 months
Number of Patients to Achieve Sustained Complete Remission 12 Months
Time frame: 12 months
Number of Patients to Achieve Sustained Complete Remission 18 Months
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Granulomatosis With Polyangiitis
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
Active, not recruitingPhase 2
Iptacopan in Patients With ANCA Associated Vasculitis
Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Active, not recruitingPhase 1/2
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis
Granulomatosis With Polyangiitis, Wegener Granulomatosis
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Specks, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab and Rituximab in people with Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.