Trial · NCT02994927
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
NCT02994927, Phase 3, Completed, Amgen; results first posted 2022-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis. Trials, record NCT02994927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02994927
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
- NCT number
- NCT02994927
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 331 participants, actual
- Lead sponsor
- Amgen
- Conditions
- ANCA-Associated Vasculitis
- Interventions
- Avacopan, Prednisone, Cyclophosphamide, Rituximab, Azathioprine
- First posted
- 2016-12-16
- Last updated
- 2025-03-24
- Results first posted
- 2022-09-09
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving Disease Remission at Week 26 | 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). |
| Primary | Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | 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 | Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | From day 1 throughout the study period (day 421/week 60) | AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse event |
| Secondary | Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI | Baseline, Week 13 and 26 | 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). |
| 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 | Week 4 | 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). |
| 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 | Baseline, Week 26 and 52 | 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). |
| Secondary | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study | Week 52 | 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: 1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or 2. 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). |
| Secondary | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period | Week 52 | 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: 1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or 2. 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). |
| Secondary | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks | Baseline, Week 26 and 52 | 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 |
| 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 | Baseline, Week 4, 26 and 52 | BVAS=Birmingham Vasculitis Activity Score UACR=Urinary albumin:creatinine ratio |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Achieving Disease Remission at Week 26 | Week 26 | 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. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | Week 52 | 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. | percentage of participants | NUMBER |
| SECONDARY | Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | From day 1 throughout the study period (day 421/week 60) | Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. | Number | NUMBER |
| SECONDARY | Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI | Baseline, Week 13 and 26 | 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. | Glucocorticoid Toxicity Index | LEAST_SQUARES_MEAN |
| 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 | Week 4 | 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. | percentage of participants | NUMBER |
| 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 | Baseline, Week 26 and 52 | 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. | Change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study | Week 52 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period | Week 52 | 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. | percentage of participants | NUMBER |
| SECONDARY | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks | Baseline, Week 26 and 52 | 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. | Change in eGFR (mL/min/1.73 m^2) | LEAST_SQUARES_MEAN |
| 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 | Baseline, Week 4, 26 and 52 | 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. | Percentage change | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Disease Remission at Week 26 | Prednisone Group | 70.1 | 95% Confidence Interval 62.5 to 77.0 | percentage of participants | |
| Percentage of Subjects Achieving Disease Remission at Week 26 | Avacopan Group | 72.3 | 95% Confidence Interval 64.8 to 78.9 | percentage of participants | |
| Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | Prednisone Group | 54.9 | 95% Confidence Interval 46.9 to 62.6 | percentage of participants | |
| Percentage of Subjects Achieving Sustained Disease Remission at Week 52 | Avacopan Group | 65.7 | 95% Confidence Interval 57.9 to 72.8 | percentage of participants | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Prednisone Group | Number of subjects with at least one TEAE | 161 | Number | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Avacopan Group | Number of subjects with at least one TEAE | 164 | Number | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Prednisone Group | Number of TEAEs | 2139 | Number | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Avacopan Group | Number of TEAEs | 1779 | Number | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Prednisone Group | Number of subjects with SAEs | 74 | Number | |
| Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs | Avacopan Group | Number of subjects with SAEs | 70 | Number |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prednisone Group | 165 | |
| Overall Study | STARTED | Avacopan Group | 166 | |
| Overall Study | COMPLETED | Prednisone Group | 150 | |
| Overall Study | COMPLETED | Avacopan Group | 151 | |
| Overall Study | NOT COMPLETED | Prednisone Group | 15 | |
| Overall Study | NOT COMPLETED | Avacopan Group | 15 |
Source ClinicalTrials.gov
Adverse events394
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Prednisone Group | 29 | 164 | 31 |
| other | Hypertension | Vascular disorders | Avacopan Group | 30 | 166 | 36 |
| other | Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | Prednisone Group | 34 | 164 | 46 |
| other | Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | Avacopan Group | 26 | 166 | 30 |
| other | Oedema peripheral | General disorders | Prednisone Group | 40 | 164 | 56 |
| other | Oedema peripheral | General disorders | Avacopan Group | 35 | 166 | 39 |
| other | Fatigue | General disorders | Prednisone Group | 15 | 164 | 15 |
| other | Fatigue | General disorders | Avacopan Group | 17 | 166 | 19 |
| other | Pyrexia | General disorders | Prednisone Group | 19 | 164 | 25 |
| other | Pyrexia | General disorders | Avacopan Group | 15 | 166 | 18 |
1 to 10 of 394Source ClinicalTrials.gov
See all 394 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prednisone Group | 4 | 164 |
| Total, all-cause mortality | Avacopan Group | 2 | 166 |
| Total, other adverse events | Prednisone Group | 161 | 164 |
| Total, other adverse events | Avacopan Group | 164 | 166 |
| Total, serious adverse events | Prednisone Group | 74 | 164 |
| Total, serious adverse events | Avacopan Group | 70 | 166 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prednisone Group vs Avacopan Group: Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study | Trial comparisons |
| Prednisone Group vs Avacopan Group: Number of Subjects With Clinically Significant ECG Changes From Baseline | Trial comparisons |
| Prednisone Group vs Avacopan Group: deaths from any cause | Trial comparisons |
| Prednisone Group vs Avacopan Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02994927
GET https://conductscience.org/api/trials/v1/NCT02994927/registered?page=2