Trial · NCT05376319
PR3-AAV Resilient Remission or PRRR
NCT05376319, Phase 2, Terminated, Mayo Clinic; results first posted 2024-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PR3-AAV Resilient Remission or PRRR. Trials, record NCT05376319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05376319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PR3-AAV Resilient Remission or PRRR
- NCT number
- NCT05376319
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis, ANCA Associated Vasculitis
- Interventions
- Obinutuzumab, Rituximab
- First posted
- 2022-05-17
- Last updated
- 2026-05-06
- Results first posted
- 2024-07-31
- Limitations and caveats
- Study was discontinued early due to funding termination by industry sponsor.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. | 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). |
| Secondary | Number of Patients to Achieve Sustained Complete Remission 6 Months | 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. |
| Secondary | Number of Patients to Achieve Sustained Complete Remission 12 Months | 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. |
| Secondary | Number of Patients to Achieve Sustained Complete Remission 18 Months | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. | 6 months | Terminated study due lack of funding. Data was not collected nor analyzed due to lack of funding. Only one subject in each arm reached 6 months. Data was not collected nor analyzed for 1 subject in the Intravenous dose of obinutuzumab and 3 subjects in the Intravenous dose of rituximab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients to Achieve Sustained Complete Remission 6 Months | 6 months | Terminated study due lack of funding. Data was not collected nor analyzed due to lack of funding. Only one subject in each arm reached 6 months. Data was not collected nor analyzed for 1 subject in the Intravenous dose of obinutuzumab and 3 subjects in the Intravenous dose of rituximab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients to Achieve Sustained Complete Remission 12 Months | 12 months | Terminated study due lack of funding. Data was not collected nor analyzed due to lack of funding. Data was not collected nor analyzed for 2 subjects in the Intravenous dose of obinutuzumab and 4 subjects in the Intravenous dose of rituximab. | ||
| SECONDARY | Number of Patients to Achieve Sustained Complete Remission 18 Months | 18 months | Terminated study due lack of funding. Data was not collected nor analyzed due to lack of funding. Data was not collected nor analyzed for 2 subjects in the Intravenous dose of obinutuzumab and 4 subjects in the Intravenous dose of rituximab. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. | Intravenous Dose of Obinutuzumab | 0 | Participants | ||
| Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. | Intravenous Dose of Rituximab | 0 | Participants | ||
| Number of Patients to Achieve Sustained Complete Remission 6 Months | Intravenous Dose of Obinutuzumab | 1 | Participants | ||
| Number of Patients to Achieve Sustained Complete Remission 6 Months | Intravenous Dose of Rituximab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravenous Dose of Obinutuzumab | 2 | |
| Overall Study | STARTED | Intravenous Dose of Rituximab | 4 | |
| Overall Study | COMPLETED | Intravenous Dose of Obinutuzumab | 0 | |
| Overall Study | COMPLETED | Intravenous Dose of Rituximab | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Dose of Obinutuzumab | 2 | |
| Overall Study | NOT COMPLETED | Intravenous Dose of Rituximab | 4 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Intravenous Dose of Obinutuzumab | 1 | 2 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | Intravenous Dose of Rituximab | 1 | 4 | 1 |
| other | Bilateral leg cramps | Musculoskeletal and connective tissue disorders | Intravenous Dose of Obinutuzumab | 1 | 2 | 1 |
| other | Bilateral leg cramps | Musculoskeletal and connective tissue disorders | Intravenous Dose of Rituximab | 0 | 4 | 0 |
| other | Chills | General disorders | Intravenous Dose of Obinutuzumab | 1 | 2 | 1 |
| other | Chills | General disorders | Intravenous Dose of Rituximab | 1 | 4 | 1 |
| other | Conjunctivitis | Eye disorders | Intravenous Dose of Obinutuzumab | 1 | 2 | 1 |
| other | Conjunctivitis | Eye disorders | Intravenous Dose of Rituximab | 0 | 4 | 0 |
| other | Covid-19 | Infections and infestations | Intravenous Dose of Obinutuzumab | 1 | 2 | 1 |
| other | Covid-19 | Infections and infestations | Intravenous Dose of Rituximab | 0 | 4 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous Dose of Obinutuzumab | 0 | 2 |
| Total, all-cause mortality | Intravenous Dose of Rituximab | 0 | 4 |
| Total, other adverse events | Intravenous Dose of Obinutuzumab | 2 | 2 |
| Total, other adverse events | Intravenous Dose of Rituximab | 4 | 4 |
| Total, serious adverse events | Intravenous Dose of Obinutuzumab | 1 | 2 |
| Total, serious adverse events | Intravenous Dose of Rituximab | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intravenous Dose of Obinutuzumab vs Intravenous Dose of Rituximab: Number of Patients to Achieve Sustained Complete Remission 6 Months | Trial comparisons |
| Intravenous Dose of Obinutuzumab vs Intravenous Dose of Rituximab: Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. | Trial comparisons |
| Intravenous Dose of Obinutuzumab vs Intravenous Dose of Rituximab: deaths from any cause | Trial comparisons |
| Intravenous Dose of Obinutuzumab vs Intravenous Dose of Rituximab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05376319
GET https://conductscience.org/api/trials/v1/NCT05376319/events?page=2