Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ADVOCATE | Other Identifier | ChemoCentryx |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.
Complement 5a and its receptor C5aR (CD88) are involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
This is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or Cyclophosphamide/Azathioprine.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone group | Active Comparator | Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. |
|
| Avacopan group | Experimental | Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacopan | Drug | Avacopan 30 mg twice daily orally for 52 weeks (364 days): - Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose. Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Disease Remission at Week 26 | Disease remission at Week 26 was defined as:
| Week 26 |
| Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | Sustained remission at Week 52 was defined as:
| Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse event | From day 1 throughout the study period (day 421/week 60) |
| Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Huntsville | Alabama | 35801 | United States | ||
| Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41052893 | Derived | Geetha D, Neumann T, Karras A, Cid MC, Merkel PA, Bray S, Bozeman AM, Jayne DRW; Members of the ADVOCATE Study Group. Efficacy and safety of avacopan for treatment of patients with ANCA-associated vasculitis receiving cyclophosphamide. RMD Open. 2025 Oct 5;11(4):e005743. doi: 10.1136/rmdopen-2025-005743. | |
| 37979959 | Derived |
Not provided
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Screening details:
Of 386 subjects screened, 331 were enrolled in the study and randomized to treatment. Reasons for subjects failing screening included not meeting inclusion/exclusion criteria, withdrawal by subject, adverse event (AE) and other.
A total of 143 study centers randomized at least 1 subject. The target enrollment was 300 subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone Group | Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone |
| FG001 | Avacopan Group | Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2019 | May 19, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
This study was double-blind, double-dummy, i.e., placebo capsules were identical in appearance to the avacopan capsules, and prednisone capsules also had matching placebo capsules. To maintain the blind, multiple measures were taken (i.e., randomization code was not accessible to study personnel who had contact with study centers or who were involved in data management and analysis for the duration of the study).
|
|
| Prednisone | Drug | Avacopan-matching placebo twice daily orally for 52 weeks (364 days): - Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose. Oral prednisone tapering regimen over 20 weeks (140 days):
|
|
| Cyclophosphamide | Drug | Orally or intravenously administered |
|
| Rituximab | Biological | Intravenously administered |
|
| Azathioprine | Drug | Orally administered |
|
GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score; GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score; The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health). |
| Baseline, Week 13 and 26 |
| Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC | AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Week 4 |
| Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index | SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2) EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health). | Baseline, Week 26 and 52 |
| Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study | The median time to relapse was not estimable because of small number of relapsed subjects. A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Week 52 |
| Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period | The median time to relapse was not estimable because of small number of relapsed subjects. A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Week 52 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks | Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component. eGFR=estimated glomerular filtration rate BVAS=Birmingham Vasculitis Activity Score MDRD=Modification of Diet in Renal Disease | Baseline, Week 26 and 52 |
| In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks | BVAS=Birmingham Vasculitis Activity Score UACR=Urinary albumin:creatinine ratio | Baseline, Week 4, 26 and 52 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks | BVAS=Birmingham Vasculitis Activity Score MCP-1=monocyte chemoattractant protein-1 | Baseline, Week 26 and 52 |
| Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points | VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2) | Baseline, Week 26 and 52 |
| Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2) | Baseline, Week 26 and 52 |
| Change From Baseline in Vital Signs (1/5) | Baseline, Week 26 and 52 |
| Change From Baseline in Vital Signs (2/5) | Baseline, Week 26 and 52 |
| Change From Baseline in Vital Signs (3/5) | Baseline, Week 26 and 52 |
| Change From Baseline in Vital Signs (4/5) | Baseline, Week 26 and 52 |
| Change From Baseline in Vital Signs (5/5) | BMI=Body Mass Index | Baseline, Week 26 and 52 |
| Number of Subjects With Clinically Significant ECG Changes From Baseline | Clinical significance was assessed by the individual reading of the ECGs ECG=Electrocardiogram | From day 1 throughout the study period (day 421/week 60) |
| Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator | AE=Adverse Event | From day 1 throughout the study period (day 421/week 60) |
| Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity | WBC=White Blood Cell TEAE=Treatment-Emergent Adverse Event | From day 1 throughout the study period (day 421/week 60) |
| Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study | BVAS=Birmingham Vasculitis Activity Score; A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | From day 1 throughout the study period (day 421/week 60) |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Clinical Trial Site | Phoenix | Arizona | 85032 | United States |
| Clinical Trial Site | Los Angeles | California | 90048 | United States |
| Clinical Trial Site | Santa Monica | California | 90404 | United States |
| Clinical Trial Site | Aurora | Colorado | 80045 | United States |
| Clinical Trial Site | Washington D.C. | District of Columbia | 20007 | United States |
| Clinical Trial Site | Daytona Beach | Florida | 32117 | United States |
| Clinical Trial Site | Tampa | Florida | 33612 | United States |
| Clinical Trial Site | Atlanta | Georgia | 30322 | United States |
| Clinical Trial Site | Meridian | Idaho | 83605 | United States |
| Clinical Trial Site | Chicago | Illinois | 60637 | United States |
| Clinical Trial Site | Indianapolis | Indiana | 46202 | United States |
| Clinical Trial Site | Kansas City | Kansas | 66160 | United States |
| Clinical Trial Site | Lexington | Kentucky | 40536 | United States |
| Clinical Trial Site | Shreveport | Louisiana | 71101 | United States |
| Clinical Trial Site | Baltimore | Maryland | 21224 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02118 | United States |
| Clinical Trial Site | Ann Arbor | Michigan | 48109 | United States |
| Clinical Trial Site | Minneapolis | Minnesota | 55414 | United States |
| Clinical Trial Site | Rochester | Minnesota | 55905 | United States |
| Clinical Trial Site | St Louis | Missouri | 63110 | United States |
| Clinical Trial Site | Great Neck | New York | 11021 | United States |
| Clinical Trial Site | Mineola | New York | 11501 | United States |
| Clinical Trial Site | New York | New York | 10021 | United States |
| Clinical Trial Site | New York | New York | 10032 | United States |
| Clinical Trial Site | Chapel Hill | North Carolina | 27599 | United States |
| Clinical Trial Site | Greenville | North Carolina | 27834 | United States |
| Clinical Trial Site | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Trial Site | Cleveland | Ohio | 44195 | United States |
| Clinical Trial Site | Columbus | Ohio | 43210 | United States |
| Clinical Trial Site | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Trial Site | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trial Site | Pittsburgh | Pennsylvania | 15225 | United States |
| Clinical Trial Site | Providence | Rhode Island | 02903 | United States |
| Clinical Trial Site | Charleston | South Carolina | 29406 | United States |
| Clinical Trial Site | Dallas | Texas | 75235 | United States |
| Clinical Trial Site | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Salt Lake City | Utah | 84132 | United States |
| Clinical Trial Site | Seattle | Washington | 98101 | United States |
| Clinical Trial Site | Adelaide | Australia |
| Clinical Trial Site | Auchenflower | Australia |
| Clinical Trial Site | Brisbane | Australia |
| Clinical Trial Site | Clayton | Australia |
| Clinical Trial Site | Concord | Australia |
| Clinical Trial Site | Heidelberg | Australia |
| Clinical Trial Site | Liverpool | Australia |
| Clinical Trial Site | Nambour | Australia |
| Clinical Trial Site | Nedlands | Australia |
| Clinical Trial Site | Randwick | Australia |
| Clinical Trial Site | Saint Albans | Australia |
| Clinical Trial Site | Southport | Australia |
| Clinical Trial Site | St Leonards | Australia |
| Clinical Trial Site | Westmead | Australia |
| Clinical Trial Site | Woolloongabba | Australia |
| Clinical Trial Site | Feldkirch | Austria |
| Clinical Trial Site | Graz | Austria |
| Clinical Trial Site | Innsbruck | Austria |
| Clinical Trial Site | Antwerp | Belgium |
| Clinical Trial Site | Brussels | Belgium |
| Clinical Trial Site | Leuven | Belgium |
| Clinical Trial Site | Liège | Belgium |
| Clinical Trial Site | Calgary | Canada |
| Clinical Trial Site | Greenfield Park | Canada |
| Clinical Trial Site | Hamilton | Canada |
| Clinical Trial Site | Montreal | Canada |
| Clinical Trial Site | Québec | Canada |
| Clinical Trial Site | Sherbrooke | Canada |
| Clinical Trial Site | Toronto | Canada |
| Clinical Trial Site | Vancouver | Canada |
| Clinical Trial Site | Olomouc | Czechia |
| Clinical Trial Site | Prague | Czechia |
| Clinical Trial Site | Aalborg | Denmark |
| Clinical Trial Site | Aarhus | Denmark |
| Clinical Trial Site | Copenhagen | Denmark |
| Clinical Trial Site | Odense | Denmark |
| Clinical Trial Site | Roskilde | Denmark |
| Clinical Trial Site | Angers | France |
| Clinical Trial Site | Bordeaux | France |
| Clinical Trial Site | Boulogne-sur-Mer | France |
| Clinical Trial Site | Brest | France |
| Clinical Trial Site | Bron | France |
| Clinical Trial Site | Caen | France |
| Clinical Trial Site | Colmar | France |
| Clinical Trial Site | Grenoble | France |
| Clinical Trial Site | Marseille | France |
| Clinical Trial Site | Metz | France |
| Clinical Trial Site | Nantes | France |
| Clinical Trial Site | Nîmes | France |
| Clinical Trial Site | Paris | France |
| Clinical Trial Site | Toulouse | France |
| Clinical Trial Site | Valenciennes | France |
| Clinical Trial Site | Aachen | Germany |
| Clinical Trial Site | Bad Bramstedt | Germany |
| Clinical Trial Site | Berlin | Germany |
| Clinical Trial Site | Cologne | Germany |
| Clinical Trial Site | Dresden | Germany |
| Clinical Trial Site | Essen | Germany |
| Clinical Trial Site | Freiburg im Breisgau | Germany |
| Clinical Trial Site | Fulda | Germany |
| Clinical Trial Site | Hamburg | Germany |
| Clinical Trial Site | Hanover | Germany |
| Clinical Trial Site | Heidelberg | Germany |
| Clinical Trial Site | Jena | Germany |
| Clinical Trial Site | Kirchheim unter Teck | Germany |
| Clinical Trial Site | Leipzig | Germany |
| Clinical Trial Site | Ludwigshafen | Germany |
| Clinical Trial Site | Lübeck | Germany |
| Clinical Trial Site | Mannheim | Germany |
| Clinical Trial Site | Munich | Germany |
| Clinical Trial Site | Tübingen | Germany |
| Clinical Trial Site | Villingen-Schwenningen | Germany |
| Clinical Trial Site | Budapest | Hungary |
| Clinical Trial Site | Debrecen | Hungary |
| Clinical Trial Site | Cork | Ireland |
| Clinical Trial Site | Dublin | Ireland |
| Clinical Trial Site | Ancona | Italy |
| Clinical Trial Site | Florence | Italy |
| Clinical Trial Site | Genova | Italy |
| Clinical Trial Site | Milan | Italy |
| Clinical Trial Site | Monza | Italy |
| Clinical Trial Site | Parma | Italy |
| Clinical Trial Site | Reggio Emilia | Italy |
| Clinical Trial Site | Torino | Italy |
| Clinical Trial Site | Udine | Italy |
| Clinical Trial Site | Aichi | Japan |
| Clinical Trial Site | Akita | Japan |
| Clinical Trial Site | Chiba | Japan |
| Clinical Trial Site | Hiroshima | Japan |
| Clinical Trial Site | Hokkaido | Japan |
| Clinical Trial Site | Ishikawa | Japan |
| Clinical Trial Site | Kagawa | Japan |
| Clinical Trial Site | Kanagawa | Japan |
| Clinical Trial Site | Kobe | Japan |
| Clinical Trial Site | Miyazaki | Japan |
| Clinical Trial Site | Nagoya | Japan |
| Clinical Trial Site | Okayama | Japan |
| Clinical Trial Site | Osaka | Japan |
| Clinical Trial Site | Saitama | Japan |
| Clinical Trial Site | Shimane | Japan |
| Clinical Trial Site | Shizuoka | Japan |
| Clinical Trial Site | Tokyo | Japan |
| Clinical Trial Site | Toyama | Japan |
| Clinical Trial Site | Yokohama | Japan |
| Clinical Trial Site | Groningen | Netherlands |
| Clinical Trial Site | Leiden | Netherlands |
| Clinical Trial Site | Rotterdam | Netherlands |
| Clinical Trial Site | Christchurch | New Zealand |
| Clinical Trial Site | Dunedin | New Zealand |
| Clinical Trial Site | Grafton | New Zealand |
| Clinical Trial Site | Hamilton | New Zealand |
| Clinical Trial Site | Takapuna | New Zealand |
| Clinical Trial Site | Nordbyhagen | Norway |
| Clinical Trial Site | Oslo | Norway |
| Clinical Trial Site | Tromsø | Norway |
| Clinical Trial Site | Badalona | Spain |
| Clinical Trial Site | Barcelona | Spain |
| Clinical Trial Site | Burela de Cabo | Spain |
| Clinical Trial Site | Lleida | Spain |
| Clinical Trial Site | Madrid | Spain |
| Clinical Trial Site | San Sebastián | Spain |
| Clinical Trial Site | Linköping | Sweden |
| Clinical Trial Site | Lund | Sweden |
| Clinical Trial Site | Örebro | Sweden |
| Clinical Trial Site | Stockholm | Sweden |
| Clinical Trial Site | Uppsala | Sweden |
| Clinical Trial Site | Basel | Switzerland |
| Clinical Trial Site | Bern | Switzerland |
| Clinical Trial Site | Fribourg | Switzerland |
| Clinical Trial Site | Lausanne | Switzerland |
| Clinical Trial Site | Sankt Gallen | Switzerland |
| Clinical Trial Site | Zurich | Switzerland |
| Clinical Trial Site | Aberdeen | United Kingdom |
| Clinical Trial Site | Basildon | United Kingdom |
| Clinical Trial Site | Birmingham | United Kingdom |
| Clinical Trial Site | Bristol | United Kingdom |
| Clinical Trial Site | Cambridge | United Kingdom |
| Clinical Trial Site | Canterbury | United Kingdom |
| Clinical Trial Site | Cardiff | United Kingdom |
| Clinical Trial Site | Carshalton | United Kingdom |
| Clinical Trial Site | Dorchester | United Kingdom |
| Clinical Trial Site | Dudley | United Kingdom |
| Clinical Trial Site | Exeter | United Kingdom |
| Clinical Trial Site | Glasgow | United Kingdom |
| Clinical Trial Site | Inverness | United Kingdom |
| Clinical Trial Site | Kirkcaldy | United Kingdom |
| Clinical Trial Site | Leeds | United Kingdom |
| Clinical Trial Site | Leicester | United Kingdom |
| Clinical Trial Site | Liverpool | United Kingdom |
| Clinical Trial Site | London | United Kingdom |
| Clinical Trial Site | Manchester | United Kingdom |
| Clinical Trial Site | Newcastle | United Kingdom |
| Clinical Trial Site | Nottingham | United Kingdom |
| Clinical Trial Site | Oxford | United Kingdom |
| Clinical Trial Site | Reading | United Kingdom |
| Clinical Trial Site | Salford | United Kingdom |
| Clinical Trial Site | Westcliff-on-Sea | United Kingdom |
| Geetha D, Dua A, Yue H, Springer J, Salvarani C, Jayne D, Merkel P; ADVOCATE Study Group. Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. Ann Rheum Dis. 2024 Jan 11;83(2):223-232. doi: 10.1136/ard-2023-224816. |
| 35167187 | Derived | Soulsby WD. Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis". ACR Open Rheumatol. 2022 Jul;4(7):558-561. doi: 10.1002/acr2.11412. Epub 2022 Feb 15. |
| 33596356 | Derived | Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386. |
| 32088663 | Derived | Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
In the Prednisone group, one subject was randomized but withdrawn for not meeting disease criteria prior to dosing.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone Group | Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone |
| BG001 | Avacopan Group | Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Geographic Region | Count of Participants | Participants |
| ||||||||||||||||
| ANCA-associated vasculitis Status | ANCA=anti-neutrophil cytoplasmic autoantibody | Count of Participants | Participants |
| |||||||||||||||
| ANCA Positivity | ANCA=anti-neutrophil cytoplasmic autoantibody | Count of Participants | Participants |
| |||||||||||||||
| Standard of Care Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Type of ANCA-associated vasculitis | ANCA=anti-neutrophil cytoplasmic autoantibody | Count of Participants | Participants |
| |||||||||||||||
| BVAS Entry Criteria | BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). * Subjects can appear in more than one category | Count of Participants | Participants |
| |||||||||||||||
| BVAS Components | BVAS=Birmingham Vasculitis Activity Score * Subjects can appear in more than one category | Count of Participants | Participants |
| |||||||||||||||
| Age at screening | Mean | Standard Deviation | years |
| |||||||||||||||
| Age at diagnosis of ANCA-associated Vasculitis | ANCA=anti-neutrophil cytoplasmic autoantibody | Mean | Standard Deviation | years |
| ||||||||||||||
| Duration of ANCA-Associated Vasculitis | ANCA=anti-neutrophil cytoplasmic autoantibody | Mean | Standard Deviation | months |
| ||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram(s) |
| |||||||||||||||
| BMI | BMI=Body Mass Index | Two subjects did not have a baseline BMI provided (one in each treatment group) | Mean | Standard Deviation | kilogram(s)/square meter |
| |||||||||||||
| BVAS Score | BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| VDI Score | VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). | Two subjects did not have a baseline VDI Score (one in each treatment group) | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Disease Remission at Week 26 | Disease remission at Week 26 was defined as:
| Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | Sustained remission at Week 52 was defined as:
| Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse event | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Posted | Number | Number | From day 1 throughout the study period (day 421/week 60) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI | GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score; GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score; The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health). | Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported. | Posted | Least Squares Mean | Standard Error | Glucocorticoid Toxicity Index | Baseline, Week 13 and 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC | AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index | SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2) EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health). | Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported. | Posted | Least Squares Mean | Standard Error | Change from baseline | Baseline, Week 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study | The median time to relapse was not estimable because of small number of relapsed subjects. A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Intent-to-Treat (ITT) Subjects in the analysis population for the specified treatment group. ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period | The median time to relapse was not estimable because of small number of relapsed subjects. A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Intent-to-Treat (ITT) Subjects who achieved BVAS=0 during the 52 week treatment period. ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks | Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component. eGFR=estimated glomerular filtration rate BVAS=Birmingham Vasculitis Activity Score MDRD=Modification of Diet in Renal Disease | Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS). ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Change in eGFR (mL/min/1.73 m^2) | Baseline, Week 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks | BVAS=Birmingham Vasculitis Activity Score UACR=Urinary albumin:creatinine ratio | Intent-to-Treat (ITT) Subjects With Renal Disease (based on BVAS) and Albuminuria (UACR>=10 mg/g creatinine) at Baseline ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline, Week 4, 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks | BVAS=Birmingham Vasculitis Activity Score MCP-1=monocyte chemoattractant protein-1 | Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS). ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline, Week 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points | VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). | Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | 10^3 cells/μL | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | 10^9 cells/L | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | 10^12 cells/L | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | g/dL | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | percentage of red blood cells | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | U/L | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs (1/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | mmHg | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs (2/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Posted | Mean | Standard Error | beats/min | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs (3/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | degree Celsius | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs (4/5) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | kilogram(s) | Baseline, Week 26 and 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs (5/5) | BMI=Body Mass Index | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported. | Posted | Mean | Standard Error | kilogram(s)/ square meter | Baseline, Week 26 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Clinically Significant ECG Changes From Baseline | Clinical significance was assessed by the individual reading of the ECGs ECG=Electrocardiogram | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Posted | Count of Participants | Participants | From day 1 throughout the study period (day 421/week 60) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator | AE=Adverse Event | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Posted | Count of Participants | Participants | From day 1 throughout the study period (day 421/week 60) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity | WBC=White Blood Cell TEAE=Treatment-Emergent Adverse Event | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Posted | Count of Participants | Participants | From day 1 throughout the study period (day 421/week 60) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study | BVAS=Birmingham Vasculitis Activity Score; A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). | Intended-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. | Posted | Count of Participants | Participants | From day 1 throughout the study period (day 421/week 60) |
|
From day 1 throughout the study period (day 421/week 60)
An AE was considered treatment-emergent if the start date/time of the event was on or after the date/time of first dose of study drug through 56 days following the last dose administered during the randomized treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone Group | Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. The safety population included all subjects who were randomized and had received at least one dose of study drug. | 4 | 164 | 74 | 164 | 161 | 164 |
| EG001 | Avacopan Group | Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. The safety population included all subjects who were randomized and had received at least one dose of study drug. | 2 | 166 | 70 | 166 | 164 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulomatosis with polyangiitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Microscopic polyangiitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mononeuropathy multiplex | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Antineutrophil cytoplasmic antibody increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Vasculitis gastrointestinal | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Carcinoma in situ of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Granulomatous lymphadenitis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Medical observation | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ophthalmic herpes simplex | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 19.1 | Systematic Assessment | Worsening of vasculitis is reported as the Preferred Term of "anti-neutrophil cytoplasmic antibody-positive vasculitis". |
|
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trial disclosure | ChemoCentryx, Inc. | 650.210.2900 | clinicaltrials@chemocentryx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2019 | May 19, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D014657 | Vasculitis |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620232 | avacopan |
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Adults (18-50 years) |
|
|
| Adults (51-64 years) |
|
|
| Adults (65-75 years) |
|
|
| Adults (>75 years) |
|
|
|
|
|
|
| Austria |
|
|
| Belgium |
|
|
| Canada |
|
|
| Czechia |
|
|
| Denmark |
|
|
| France |
|
|
| Germany |
|
|
| Italy |
|
|
| Japan |
|
|
| Netherlands |
|
|
| New Zealand |
|
|
| Ireland |
|
|
| Spain |
|
|
| Sweden |
|
|
| Switzerland |
|
|
| United Kingdom |
|
|
| United States |
|
|
|
| Europe and Rest of World excluding Japan |
|
|
| Japan |
|
|
|
| Relapsed |
|
|
|
| Myeloperoxidase (MPO) |
|
|
|
| Intravenous (IV) Cyclophosphamide |
|
|
| Oral Cyclophosphamide |
|
|
|
| Microscopic polyangiitis (MPA) |
|
|
|
| Three or more minor items |
|
|
| Two renal items of proteinuria and hematuria |
|
|
|
| Cutaneous |
|
|
| Mucous Membranes/Eyes |
|
|
| Ear Nose and Throat |
|
|
| Chest |
|
|
| Cardiovascular |
|
|
| Abdominal |
|
|
| Renal + Other (RBC Casts and/or Glomerulonephritis) |
|
|
| Nervous System |
|
|
|
|
|
|
|
|
|
| Summary score test | = 0.2387 | Common difference in remission rates | 3.4 | 2-Sided | 95 | -6.0 | 12.8 | Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference | Superiority | The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. |
|
|
Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|