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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02994927




Registration number
NCT02994927
Ethics application status
Date submitted
11/12/2016
Date registered
16/12/2016

Titles & IDs
Public title
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
Scientific title
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine
Secondary ID [1] 0 0
ADVOCATE
Secondary ID [2] 0 0
CL010_168
Universal Trial Number (UTN)
Trial acronym
ADVOCATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ANCA-Associated Vasculitis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avacopan
Treatment: Drugs - Prednisone
Treatment: Drugs - Cyclophosphamide
Treatment: Other - Rituximab
Treatment: Drugs - Azathioprine

Active comparator: Prednisone group - Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Experimental: Avacopan group - Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Cyclophosphamide
Orally or intravenously administered

Treatment: Other: Rituximab
Intravenously administered

Treatment: Drugs: Azathioprine
Orally administered
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Achieving Disease Remission at Week 26
Timepoint [1] 0 0
Week 26
Primary outcome [2] 0 0
Percentage of Subjects Achieving Sustained Disease Remission at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
Timepoint [1] 0 0
From day 1 throughout the study period (day 421/week 60)
Secondary outcome [2] 0 0
Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
Timepoint [2] 0 0
Baseline, Week 13 and 26
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, Week 26 and 52
Secondary outcome [5] 0 0
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
Timepoint [7] 0 0
Baseline, Week 26 and 52
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Week 4, 26 and 52
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 26 and 52
Secondary outcome [10] 0 0
Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
Timepoint [10] 0 0
Baseline, Week 26 and 52
Secondary outcome [11] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
Timepoint [11] 0 0
Baseline, Week 26 and 52
Secondary outcome [12] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
Timepoint [12] 0 0
Baseline, Week 26 and 52
Secondary outcome [13] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
Timepoint [13] 0 0
Baseline, Week 26 and 52
Secondary outcome [14] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
Timepoint [14] 0 0
Baseline, Week 26 and 52
Secondary outcome [15] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
Timepoint [15] 0 0
Baseline, Week 26 and 52
Secondary outcome [16] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
Timepoint [16] 0 0
Baseline, Week 26 and 52
Secondary outcome [17] 0 0
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
Timepoint [17] 0 0
Baseline, Week 26 and 52
Secondary outcome [18] 0 0
Change From Baseline in Vital Signs (1/5)
Timepoint [18] 0 0
Baseline, Week 26 and 52
Secondary outcome [19] 0 0
Change From Baseline in Vital Signs (2/5)
Timepoint [19] 0 0
Baseline, Week 26 and 52
Secondary outcome [20] 0 0
Change From Baseline in Vital Signs (3/5)
Timepoint [20] 0 0
Baseline, Week 26 and 52
Secondary outcome [21] 0 0
Change From Baseline in Vital Signs (4/5)
Timepoint [21] 0 0
Baseline, Week 26 and 52
Secondary outcome [22] 0 0
Change From Baseline in Vital Signs (5/5)
Timepoint [22] 0 0
Baseline, Week 26 and 52
Secondary outcome [23] 0 0
Number of Subjects With Clinically Significant ECG Changes From Baseline
Timepoint [23] 0 0
From day 1 throughout the study period (day 421/week 60)
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
From day 1 throughout the study period (day 421/week 60)
Secondary outcome [25] 0 0
Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
Timepoint [25] 0 0
From day 1 throughout the study period (day 421/week 60)
Secondary outcome [26] 0 0
Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
Timepoint [26] 0 0
From day 1 throughout the study period (day 421/week 60)

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Trial Site - Adelaide
Recruitment hospital [2] 0 0
Clinical Trial Site - Auchenflower
Recruitment hospital [3] 0 0
Clinical Trial Site - Brisbane
Recruitment hospital [4] 0 0
Clinical Trial Site - Clayton
Recruitment hospital [5] 0 0
Clinical Trial Site - Concord
Recruitment hospital [6] 0 0
Clinical Trial Site - Heidelberg
Recruitment hospital [7] 0 0
Clinical Trial Site - Liverpool
Recruitment hospital [8] 0 0
Clinical Trial Site - Nambour
Recruitment hospital [9] 0 0
Clinical Trial Site - Nedlands
Recruitment hospital [10] 0 0
Clinical Trial Site - Randwick
Recruitment hospital [11] 0 0
Clinical Trial Site - Saint Albans
Recruitment hospital [12] 0 0
Clinical Trial Site - Southport
Recruitment hospital [13] 0 0
Clinical Trial Site - St Leonards
Recruitment hospital [14] 0 0
Clinical Trial Site - Westmead
Recruitment hospital [15] 0 0
Clinical Trial Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
- Brisbane
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- Clayton
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- Concord
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- Heidelberg
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- Liverpool
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- Nambour
Recruitment postcode(s) [9] 0 0
- Nedlands
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- Randwick
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- Saint Albans
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- Southport
Recruitment postcode(s) [13] 0 0
- St Leonards
Recruitment postcode(s) [14] 0 0
- Westmead
Recruitment postcode(s) [15] 0 0
- Woolloongabba
Recruitment outside Australia
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Dorchester
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Dudley
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Exeter
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Glasgow
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Inverness
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Kirkcaldy
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Leeds
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Leicester
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Liverpool
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Manchester
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Newcastle
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Nottingham
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Oxford
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Reading
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Salford
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Westcliff-on-Sea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ChemoCentryx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02994927