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A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)

Primary Purpose

ANCA-Associated Vasculitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Avacopan

Prednisone

Cyclophosphamide

Rituximab

Azathioprine

About this trial

This is an interventional treatment trial for ANCA-Associated Vasculitis focused on measuring ANCA-associated vasculitis, complement, vasculitis, C5aR, avacopan, CCX168, MPA, GPA

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prednisone group

Avacopan group

Arm Description

Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

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

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs

AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse event

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).

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).

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).

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).

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).

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

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

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

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).

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)

Change From Baseline in Vital Signs (1/5)

Change From Baseline in Vital Signs (2/5)

Change From Baseline in Vital Signs (3/5)

Change From Baseline in Vital Signs (4/5)

Change From Baseline in Vital Signs (5/5)

BMI=Body Mass Index

Number of Subjects With Clinically Significant ECG Changes From Baseline

Clinical significance was assessed by the individual reading of the ECGs ECG=Electrocardiogram

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

Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity

WBC=White Blood Cell TEAE=Treatment-Emergent Adverse Event

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).

Full Information

NCT ID

NCT02994927

First Posted

December 11, 2016

Last Updated

August 24, 2023

Sponsor

ChemoCentryx

1. Study Identification

Unique Protocol Identification Number

NCT02994927

Brief Title

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

Acronym

ADVOCATE

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

September 7, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ChemoCentryx

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ANCA-Associated Vasculitis

Keywords

ANCA-associated vasculitis, complement, vasculitis, C5aR, avacopan, CCX168, MPA, GPA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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).

Allocation

Randomized

Enrollment

331 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisone group

Arm Type

Active Comparator

Arm Description

Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Arm Title

Avacopan group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Avacopan

Other Intervention Name(s)

CCX168

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Orally or intravenously administered

Intervention Type

Biological

Intervention Name(s)

Rituximab

Intervention Description

Intravenously administered

Intervention Type

Drug

Intervention Name(s)

Azathioprine

Intervention Description

Orally administered

Primary Outcome Measure Information:

Title

Percentage of Subjects Achieving Disease Remission at Week 26

Description

Time Frame

Week 26

Title

Percentage of Subjects Achieving Sustained Disease Remission at Week 52

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs

Description

AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse event

Time Frame

From day 1 throughout the study period (day 421/week 60)

Title

Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI

Description

Time Frame

Baseline, Week 13 and 26

Title

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

Description

Time Frame

Week 4

Title

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

Description

Time Frame

Baseline, Week 26 and 52

Title

Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study

Description

Time Frame

Week 52

Title

Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period

Description

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).

Time Frame

Week 52

Title

In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks

Description

Time Frame

Baseline, Week 26 and 52

Title

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

Description

BVAS=Birmingham Vasculitis Activity Score UACR=Urinary albumin:creatinine ratio

Time Frame

Baseline, Week 4, 26 and 52

Title

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

Description

BVAS=Birmingham Vasculitis Activity Score MCP-1=monocyte chemoattractant protein-1

Time Frame

Baseline, Week 26 and 52

Title

Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points

Description

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline in Vital Signs (1/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline in Vital Signs (2/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline in Vital Signs (3/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline in Vital Signs (4/5)

Time Frame

Baseline, Week 26 and 52

Title

Change From Baseline in Vital Signs (5/5)

Description

BMI=Body Mass Index

Time Frame

Baseline, Week 26 and 52

Title

Number of Subjects With Clinically Significant ECG Changes From Baseline

Description

Clinical significance was assessed by the individual reading of the ECGs ECG=Electrocardiogram

Time Frame

From day 1 throughout the study period (day 421/week 60)

Title

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

Description

AE=Adverse Event

Time Frame

From day 1 throughout the study period (day 421/week 60)

Title

Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity

Description

WBC=White Blood Cell TEAE=Treatment-Emergent Adverse Event

Time Frame

From day 1 throughout the study period (day 421/week 60)

Title

Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study

Description

Time Frame

From day 1 throughout the study period (day 421/week 60)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Trial Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Clinical Trial Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

Clinical Trial Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Clinical Trial Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Clinical Trial Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Clinical Trial Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Clinical Trial Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Clinical Trial Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Clinical Trial Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Clinical Trial Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Clinical Trial Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83605

Country

United States

Facility Name

Clinical Trial Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Clinical Trial Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Clinical Trial Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Clinical Trial Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Clinical Trial Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Clinical Trial Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Clinical Trial Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Clinical Trial Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Clinical Trial Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Clinical Trial Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Facility Name

Clinical Trial Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Clinical Trial Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Clinical Trial Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Clinical Trial Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Clinical Trial Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Clinical Trial Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Clinical Trial Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Clinical Trial Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Clinical Trial Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Clinical Trial Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Clinical Trial Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Clinical Trial Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Clinical Trial Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Clinical Trial Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15225

Country

United States

Facility Name

Clinical Trial Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Clinical Trial Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Clinical Trial Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Clinical Trial Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Clinical Trial Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Clinical Trial Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Clinical Trial Site

City

Adelaide

Country

Australia

Facility Name

Clinical Trial Site

City

Auchenflower

Country

Australia

Facility Name

Clinical Trial Site

City

Brisbane

Country

Australia

Facility Name

Clinical Trial Site

City

Clayton

Country

Australia

Facility Name

Clinical Trial Site

City

Concord

Country

Australia

Facility Name

Clinical Trial Site

City

Heidelberg

Country

Australia

Facility Name

Clinical Trial Site

City

Liverpool

Country

Australia

Facility Name

Clinical Trial Site

City

Nambour

Country

Australia

Facility Name

Clinical Trial Site

City

Nedlands

Country

Australia

Facility Name

Clinical Trial Site

City

Randwick

Country

Australia

Facility Name

Clinical Trial Site

City

Saint Albans

Country

Australia

Facility Name

Clinical Trial Site

City

Southport

Country

Australia

Facility Name

Clinical Trial Site

City

St Leonards

Country

Australia

Facility Name

Clinical Trial Site

City

Westmead

Country

Australia

Facility Name

Clinical Trial Site

City

Woolloongabba

Country

Australia

Facility Name

Clinical Trial Site

City

Feldkirch

Country

Austria

Facility Name

Clinical Trial Site

City

Graz

Country

Austria

Facility Name

Clinical Trial Site

City

Innsbruck

Country

Austria

Facility Name

Clinical Trial Site

City

Antwerp

Country

Belgium

Facility Name

Clinical Trial Site

City

Brussels

Country

Belgium

Facility Name

Clinical Trial Site

City

Leuven

Country

Belgium

Facility Name

Clinical Trial Site

City

Liège

Country

Belgium

Facility Name

Clinical Trial Site

City

Calgary

Country

Canada

Facility Name

Clinical Trial Site

City

Greenfield Park

Country

Canada

Facility Name

Clinical Trial Site

City

Hamilton

Country

Canada

Facility Name

Clinical Trial Site

City

Montréal

Country

Canada

Facility Name

Clinical Trial Site

City

Québec

Country

Canada

Facility Name

Clinical Trial Site

City

Sherbrooke

Country

Canada

Facility Name

Clinical Trial Site

City

Toronto

Country

Canada

Facility Name

Clinical Trial Site

City

Vancouver

Country

Canada

Facility Name

Clinical Trial Site

City

Olomouc

Country

Czechia

Facility Name

Clinical Trial Site

City

Praha

Country

Czechia

Facility Name

Clinical Trial Site

City

Aalborg

Country

Denmark

Facility Name

Clinical Trial Site

City

Aarhus

Country

Denmark

Facility Name

Clinical Trial Site

City

Copenhagen

Country

Denmark

Facility Name

Clinical Trial Site

City

Odense

Country

Denmark

Facility Name

Clinical Trial Site

City

Roskilde

Country

Denmark

Facility Name

Clinical Trial Site

City

Angers

Country

France

Facility Name

Clinical Trial Site

City

Bordeaux

Country

France

Facility Name

Clinical Trial Site

City

Boulogne-sur-Mer

Country

France

Facility Name

Clinical Trial Site

City

Brest

Country

France

Facility Name

Clinical Trial Site

City

Bron

Country

France

Facility Name

Clinical Trial Site

City

Caen

Country

France

Facility Name

Clinical Trial Site

City

Colmar

Country

France

Facility Name

Clinical Trial Site

City

Grenoble

Country

France

Facility Name

Clinical Trial Site

City

Marseille

Country

France

Facility Name

Clinical Trial Site

City

Metz

Country

France

Facility Name

Clinical Trial Site

City

Nantes

Country

France

Facility Name

Clinical Trial Site

City

Nîmes

Country

France

Facility Name

Clinical Trial Site

City

Paris

Country

France

Facility Name

Clinical Trial Site

City

Toulouse

Country

France

Facility Name

Clinical Trial Site

City

Valenciennes

Country

France

Facility Name

Clinical Trial Site

City

Aachen

Country

Germany

Facility Name

Clinical Trial Site

City

Bad Bramstedt

Country

Germany

Facility Name

Clinical Trial Site

City

Berlin

Country

Germany

Facility Name

Clinical Trial Site

City

Cologne

Country

Germany

Facility Name

Clinical Trial Site

City

Dresden

Country

Germany

Facility Name

Clinical Trial Site

City

Essen

Country

Germany

Facility Name

Clinical Trial Site

City

Freiburg

Country

Germany

Facility Name

Clinical Trial Site

City

Fulda

Country

Germany

Facility Name

Clinical Trial Site

City

Hamburg

Country

Germany

Facility Name

Clinical Trial Site

City

Hannover

Country

Germany

Facility Name

Clinical Trial Site

City

Heidelberg

Country

Germany

Facility Name

Clinical Trial Site

City

Jena

Country

Germany

Facility Name

Clinical Trial Site

City

Kirchheim unter Teck

Country

Germany

Facility Name

Clinical Trial Site

City

Leipzig

Country

Germany

Facility Name

Clinical Trial Site

City

Ludwigshafen

Country

Germany

Facility Name

Clinical Trial Site

City

Lübeck

Country

Germany

Facility Name

Clinical Trial Site

City

Mannheim

Country

Germany

Facility Name

Clinical Trial Site

City

Munich

Country

Germany

Facility Name

Clinical Trial Site

City

Tuebingen

Country

Germany

Facility Name

Clinical Trial Site

City

Villingen-Schwenningen

Country

Germany

Facility Name

Clinical Trial Site

City

Budapest

Country

Hungary

Facility Name

Clinical Trial Site

City

Debrecen

Country

Hungary

Facility Name

Clinical Trial Site

City

Cork

Country

Ireland

Facility Name

Clinical Trial Site

City

Dublin

Country

Ireland

Facility Name

Clinical Trial Site

City

Ancona

Country

Italy

Facility Name

Clinical Trial Site

City

Firenze

Country

Italy

Facility Name

Clinical Trial Site

City

Genova

Country

Italy

Facility Name

Clinical Trial Site

City

Milano

Country

Italy

Facility Name

Clinical Trial Site

City

Monza

Country

Italy

Facility Name

Clinical Trial Site

City

Parma

Country

Italy

Facility Name

Clinical Trial Site

City

Reggio Emilia

Country

Italy

Facility Name

Clinical Trial Site

City

Torino

Country

Italy

Facility Name

Clinical Trial Site

City

Udine

Country

Italy

Facility Name

Clinical Trial Site

City

Aichi

Country

Japan

Facility Name

Clinical Trial Site

City

Akita

Country

Japan

Facility Name

Clinical Trial Site

City

Chiba

Country

Japan

Facility Name

Clinical Trial Site

City

Hiroshima

Country

Japan

Facility Name

Clinical Trial Site

City

Hokkaido

Country

Japan

Facility Name

Clinical Trial Site

City

Ishikawa

Country

Japan

Facility Name

Clinical Trial Site

City

Kagawa

Country

Japan

Facility Name

Clinical Trial Site

City

Kanagawa

Country

Japan

Facility Name

Clinical Trial Site

City

Kobe

Country

Japan

Facility Name

Clinical Trial Site

City

Miyazaki

Country

Japan

Facility Name

Clinical Trial Site

City

Nagoya

Country

Japan

Facility Name

Clinical Trial Site

City

Okayama

Country

Japan

Facility Name

Clinical Trial Site

City

Osaka

Country

Japan

Facility Name

Clinical Trial Site

City

Saitama

Country

Japan

Facility Name

Clinical Trial Site

City

Shimane

Country

Japan

Facility Name

Clinical Trial Site

City

Shizuoka

Country

Japan

Facility Name

Clinical Trial Site

City

Tokyo

Country

Japan

Facility Name

Clinical Trial Site

City

Toyama

Country

Japan

Facility Name

Clinical Trial Site

City

Yokohama

Country

Japan

Facility Name

Clinical Trial Site

City

Groningen

Country

Netherlands

Facility Name

Clinical Trial Site

City

Leiden

Country

Netherlands

Facility Name

Clinical Trial Site

City

Rotterdam

Country

Netherlands

Facility Name

Clinical Trial Site

City

Christchurch

Country

New Zealand

Facility Name

Clinical Trial Site

City

Dunedin

Country

New Zealand

Facility Name

Clinical Trial Site

City

Grafton

Country

New Zealand

Facility Name

Clinical Trial Site

City

Hamilton

Country

New Zealand

Facility Name

Clinical Trial Site

City

Takapuna

Country

New Zealand

Facility Name

Clinical Trial Site

City

Nordbyhagen

Country

Norway

Facility Name

Clinical Trial Site

City

Oslo

Country

Norway

Facility Name

Clinical Trial Site

City

Tromsø

Country

Norway

Facility Name

Clinical Trial Site

City

Badalona

Country

Spain

Facility Name

Clinical Trial Site

City

Barcelona

Country

Spain

Facility Name

Clinical Trial Site

City

Burela

Country

Spain

Facility Name

Clinical Trial Site

City

Lleida

Country

Spain

Facility Name

Clinical Trial Site

City

Madrid

Country

Spain

Facility Name

Clinical Trial Site

City

San Sebastián

Country

Spain

Facility Name

Clinical Trial Site

City

Linköping

Country

Sweden

Facility Name

Clinical Trial Site

City

Lund

Country

Sweden

Facility Name

Clinical Trial Site

City

Stockholm

Country

Sweden

Facility Name

Clinical Trial Site

City

Uppsala

Country

Sweden

Facility Name

Clinical Trial Site

City

Örebro

Country

Sweden

Facility Name

Clinical Trial Site

City

Basel

Country

Switzerland

Facility Name

Clinical Trial Site

City

Bern

Country

Switzerland

Facility Name

Clinical Trial Site

City

Fribourg

Country

Switzerland

Facility Name

Clinical Trial Site

City

Lausanne

Country

Switzerland

Facility Name

Clinical Trial Site

City

St. Gallen

Country

Switzerland

Facility Name

Clinical Trial Site

City

Zürich

Country

Switzerland

Facility Name

Clinical Trial Site

City

Aberdeen

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Basildon

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Birmingham

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Bristol

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Cambridge

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Canterbury

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Cardiff

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Carshalton

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Dorchester

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Dudley

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Exeter

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Glasgow

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Inverness

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Kirkcaldy

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Leeds

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Leicester

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Liverpool

Country

United Kingdom

Facility Name

Clinical Trial Site

City

London

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Manchester

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Newcastle

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Nottingham

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Oxford

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Reading

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Salford

Country

United Kingdom

Facility Name

Clinical Trial Site

City

Westcliff-on-Sea

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

35482532

Citation

Harigai M, Kaname S, Tamura N, Dobashi H, Kubono S, Yoshida T. Efficacy and safety of avacopan in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: A subanalysis of a randomized Phase 3 study. Mod Rheumatol. 2023 Mar 2;33(2):338-345. doi: 10.1093/mr/roac037.

Results Reference

derived

PubMed Identifier

35167187

Citation

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.

Results Reference

derived

PubMed Identifier

33596356

Citation

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.

Results Reference

derived

PubMed Identifier

32088663

Citation

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.

Results Reference

derived

Learn more about this trial

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

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A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)

ANCA-Associated Vasculitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial