Trial Outcomes & Findings for PR3-AAV Resilient Remission or PRRR (NCT NCT05376319)
NCT ID: NCT05376319
Last Updated: 2024-07-31
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 months
Results posted on
2024-07-31
Participant Flow
Participant milestones
| Measure |
Intravenous Dose of Obinutuzumab
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Intravenous Dose of Obinutuzumab
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Overall Study
Funding termination
|
2
|
4
|
Baseline Characteristics
PR3-AAV Resilient Remission or PRRR
Baseline characteristics by cohort
| Measure |
Intravenous Dose of Obinutuzumab
n=2 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
n=4 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
53 years
n=7 Participants
|
53.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Intravenous Dose of Obinutuzumab
n=1 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
n=1 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intravenous Dose of Obinutuzumab
n=1 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
n=1 Participants
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Number of Patients to Achieve Sustained Complete Remission 6 Months
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Intravenous Dose of Obinutuzumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Intravenous Dose of Rituximab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravenous Dose of Obinutuzumab
n=2 participants at risk
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
n=4 participants at risk
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
Other adverse events
| Measure |
Intravenous Dose of Obinutuzumab
n=2 participants at risk
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of obinutuzumab
Obinutuzumab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
Intravenous Dose of Rituximab
n=4 participants at risk
Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis received two intravenous doses of rituximab
Rituximab: 1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 3 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg cramps
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Eye disorders
Conjunctivitis
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Infections and infestations
Covid-19
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
50.0%
1/2 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Reproductive system and breast disorders
Vaginal Yeast Infection
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Reproductive system and breast disorders
Hot Flashes
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
50.0%
2/4 • Number of events 2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Infections and infestations
Shingles
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Respiratory, thoracic and mediastinal disorders
Voice loss
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Ear and labyrinth disorders
Worsening tinnitus (left ear)
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Gastrointestinal disorders
Right-sided pleuritic abdominal pain
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Musculoskeletal and connective tissue disorders
Bilateral thigh discomfort
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Musculoskeletal and connective tissue disorders
Bilateral knee ache
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Musculoskeletal and connective tissue disorders
Bilateral ankle ache
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Blood and lymphatic system disorders
Hypertension, grade 3
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Eye disorders
Bilateral peripheral ulcerative keratitis
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/2 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected from baseline to end of study for a total of approximately eighteen months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place