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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994927
Other study ID # CL010_168
Secondary ID ADVOCATE
Status Completed
Phase Phase 3
First received
Last updated
Start date March 15, 2017
Est. completion date November 1, 2019

Study information

Verified date January 2024
Source ChemoCentryx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 331
Est. completion date November 1, 2019
Est. primary completion date September 7, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis - Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled - Use of adequate contraception - Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) - At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS) - Estimated glomerular filtration rate =15 mL/minute/1.73 m^2 at screening Exclusion Criteria: - Pregnant or breast-feeding - Alveolar hemorrhage requiring pulmonary ventilation support at screening - Any other known multi-system autoimmune disease - Required dialysis or plasma exchange within 12 weeks prior to screening - Have a kidney transplant - Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1 - Received intravenous glucocorticoids, >3000 mg methylprednisolone equivalent, within 4 weeks prior to screening - Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening - Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count > 0.01x10^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening - For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count <50,000/µL before start of dosing - Participated previously in a CCX168 study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Avacopan
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): Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was =55 kg, or 45 mg per day if the subject's body weight was <55 kg, starting on Day 1 with tapering according to a protocol-specified schedule. Adolescents who weighed =37 kg started at a prednisone-matching placebo dose of 30 mg per day.
Prednisone
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): Prednisone 60 mg per day if the subject's body weight was =55 kg, or 45 mg per day if the subject's body weight was <55 kg, starting on Day 1 with tapering according to the protocol-specified schedule. Adolescents who weighed =37 kg started at a prednisone dose of 30 mg per day.
Cyclophosphamide
Orally or intravenously administered
Biological:
Rituximab
Intravenously administered
Drug:
Azathioprine
Orally administered

Locations

Country Name City State
Australia 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
Austria Clinical Trial Site Feldkirch
Austria Clinical Trial Site Graz
Austria Clinical Trial Site Innsbruck
Belgium Clinical Trial Site Antwerp
Belgium Clinical Trial Site Brussels
Belgium Clinical Trial Site Leuven
Belgium Clinical Trial Site Liège
Canada Clinical Trial Site Calgary
Canada Clinical Trial Site Greenfield Park
Canada Clinical Trial Site Hamilton
Canada Clinical Trial Site Montréal
Canada Clinical Trial Site Québec
Canada Clinical Trial Site Sherbrooke
Canada Clinical Trial Site Toronto
Canada Clinical Trial Site Vancouver
Czechia Clinical Trial Site Olomouc
Czechia Clinical Trial Site Praha
Denmark Clinical Trial Site Aalborg
Denmark Clinical Trial Site Aarhus
Denmark Clinical Trial Site Copenhagen
Denmark Clinical Trial Site Odense
Denmark Clinical Trial Site Roskilde
France 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
Germany 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
Germany Clinical Trial Site Fulda
Germany Clinical Trial Site Hamburg
Germany Clinical Trial Site Hannover
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 Lübeck
Germany Clinical Trial Site Ludwigshafen
Germany Clinical Trial Site Mannheim
Germany Clinical Trial Site Munich
Germany Clinical Trial Site Tuebingen
Germany Clinical Trial Site Villingen-Schwenningen
Hungary Clinical Trial Site Budapest
Hungary Clinical Trial Site Debrecen
Ireland Clinical Trial Site Cork
Ireland Clinical Trial Site Dublin
Italy Clinical Trial Site Ancona
Italy Clinical Trial Site Firenze
Italy Clinical Trial Site Genova
Italy Clinical Trial Site Milano
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
Japan 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
Netherlands Clinical Trial Site Groningen
Netherlands Clinical Trial Site Leiden
Netherlands Clinical Trial Site Rotterdam
New Zealand 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
Norway Clinical Trial Site Nordbyhagen
Norway Clinical Trial Site Oslo
Norway Clinical Trial Site Tromsø
Spain Clinical Trial Site Badalona
Spain Clinical Trial Site Barcelona
Spain Clinical Trial Site Burela
Spain Clinical Trial Site Lleida
Spain Clinical Trial Site Madrid
Spain Clinical Trial Site San Sebastián
Sweden Clinical Trial Site Linköping
Sweden Clinical Trial Site Lund
Sweden Clinical Trial Site Örebro
Sweden Clinical Trial Site Stockholm
Sweden Clinical Trial Site Uppsala
Switzerland Clinical Trial Site Basel
Switzerland Clinical Trial Site Bern
Switzerland Clinical Trial Site Fribourg
Switzerland Clinical Trial Site Lausanne
Switzerland Clinical Trial Site St. Gallen
Switzerland Clinical Trial Site Zürich
United Kingdom 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 States Clinical Trial Site Ann Arbor Michigan
United States Clinical Trial Site Atlanta Georgia
United States Clinical Trial Site Aurora Colorado
United States Clinical Trial Site Baltimore Maryland
United States Clinical Trial Site Boston Massachusetts
United States Clinical Trial Site Boston Massachusetts
United States Clinical Trial Site Chapel Hill North Carolina
United States Clinical Trial Site Charleston South Carolina
United States Clinical Trial Site Chicago Illinois
United States Clinical Trial Site Cleveland Ohio
United States Clinical Trial Site Columbus Ohio
United States Clinical Trial Site Dallas Texas
United States Clinical Trial Site Daytona Beach Florida
United States Clinical Trial Site Duncansville Pennsylvania
United States Clinical Trial Site Great Neck New York
United States Clinical Trial Site Greenville North Carolina
United States Clinical Trial Site Houston Texas
United States Clinical Trial Site Huntsville Alabama
United States Clinical Trial Site Indianapolis Indiana
United States Clinical Trial Site Kansas City Kansas
United States Clinical Trial Site Lexington Kentucky
United States Clinical Trial Site Los Angeles California
United States Clinical Trial Site Meridian Idaho
United States Clinical Trial Site Mineola New York
United States Clinical Trial Site Minneapolis Minnesota
United States Clinical Trial Site New York New York
United States Clinical Trial Site New York New York
United States Clinical Trial Site Philadelphia Pennsylvania
United States Clinical Trial Site Phoenix Arizona
United States Clinical Trial Site Phoenix Arizona
United States Clinical Trial Site Pittsburgh Pennsylvania
United States Clinical Trial Site Providence Rhode Island
United States Clinical Trial Site Rochester Minnesota
United States Clinical Trial Site Saint Louis Missouri
United States Clinical Trial Site Salt Lake City Utah
United States Clinical Trial Site Santa Monica California
United States Clinical Trial Site Seattle Washington
United States Clinical Trial Site Shreveport Louisiana
United States Clinical Trial Site Tampa Florida
United States Clinical Trial Site Washington District of Columbia
United States Clinical Trial Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
ChemoCentryx

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Ireland,  Italy,  Japan,  Netherlands,  New Zealand,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects Achieving Disease Remission at Week 26 Disease remission at Week 26 was defined as:
Achieving a BVAS of 0 as determined by the Adjudication Committee;
No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;
No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).
Week 26
Primary Percentage of Subjects Achieving Sustained Disease Remission at Week 52 Sustained remission at Week 52 was defined as:
Disease remission at Week 26 as defined above;
Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;
No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.
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
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).
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).
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).
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:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
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
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:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
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
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
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
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
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). Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2) Baseline, Week 26 and 52
Secondary Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2) Baseline, Week 26 and 52
Secondary Change From Baseline in Vital Signs (1/5) Baseline, Week 26 and 52
Secondary Change From Baseline in Vital Signs (2/5) Baseline, Week 26 and 52
Secondary Change From Baseline in Vital Signs (3/5) Baseline, Week 26 and 52
Secondary Change From Baseline in Vital Signs (4/5) Baseline, Week 26 and 52
Secondary Change From Baseline in Vital Signs (5/5) BMI=Body Mass Index 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
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 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
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:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
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)
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