Trial · NCT02222155

Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

NCT02222155, Phase 2, Completed, Amgen; results first posted 2023-08-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis. Trials, record NCT02222155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02222155

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
NCT number: NCT02222155
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: Amgen
Conditions: ANCA-associated Vasculitis
Interventions: CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids, CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids, Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
First posted: 2014-08-21
Last updated: 2025-03-13
Results first posted: 2023-08-16
Limitations and caveats: The study had a small sample size and was not powered to detect differences between avacopan or placebo arms or among subgroups of patients such as newly-diagnosed vs. relapsed status, or on the basis of characteristics such as ANCA type.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events	Baseline to Day 85	This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.
Primary	Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	Day 85	Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score \[BVAS\] at Day 85 and no worsening in any body system component at day 85
Secondary	Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	Day 85	Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85.
Secondary	Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.	Day 29 and 85	Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85.
Secondary	Percent Change From Baseline to Day 85 in BVAS.	Baseline to Day 85	The Birmingham Vasculitis Activity (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). A negative percentage change indicated improvement in health.
Secondary	Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85	Day 85	Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR \[Modification of Diet in Renal Disease (MDRD equation)\], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells \[RBC\]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio).
Secondary	Change in Estimated Glomerular Filtration Rate at Day 85	Baseline to Day 85	Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline.
Secondary	Percentage Change in Estimated Glomerular Filtration Rate at Day 85	Baseline to Day 85	Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula.
Secondary	Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85	Baseline to Day 85	Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline.
Secondary	Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85	Baseline to Day 85	Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Adverse Events	Baseline to Day 85	Safety population: The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	proportion of participants	NUMBER
SECONDARY	Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.	proportion of participants	NUMBER
SECONDARY	Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.	Day 29 and 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.	proportion of participants	NUMBER
SECONDARY	Percent Change From Baseline to Day 85 in BVAS.	Baseline to Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.	percentage change from baseline	MEAN
SECONDARY	Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85	Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	proportion of participants	NUMBER
SECONDARY	Change in Estimated Glomerular Filtration Rate at Day 85	Baseline to Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	ml/min/1.73 m^2	MEAN
SECONDARY	Percentage Change in Estimated Glomerular Filtration Rate at Day 85	Baseline to Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	% change from baseline (ml/min/1.73 m²)	MEAN
SECONDARY	Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85	Baseline to Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	percentage change from baseline	MEAN
SECONDARY	Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85	Baseline to Day 85	ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.	percentage change from baseline	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of Adverse Events	Placebo BID Plus Standard of Care	13	Participants
Incidence of Adverse Events	CCX168 10 mg BID Plus Standard of Care	11	Participants
Incidence of Adverse Events	CCX168 30 mg BID Plus Standard of Care	15	Participants
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	Placebo BID Plus Standard of Care	0.85	proportion of participants
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	CCX168 10 mg BID Plus Standard of Care	0.92	proportion of participants
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	CCX168 30 mg BID Plus Standard of Care	0.8	proportion of participants
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	Placebo BID Plus Standard of Care	0.54	proportion of participants
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	CCX168 10 mg BID Plus Standard of Care	0.67	proportion of participants
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	CCX168 30 mg BID Plus Standard of Care	0.47	proportion of participants
Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.	Placebo BID Plus Standard of Care	0.15	proportion of participants

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo BID Plus Standard of Care	13
Overall Study	STARTED	CCX168 10 mg BID Plus Standard of Care	13
Overall Study	STARTED	CCX168 30 mg BID Plus Standard of Care	16
Overall Study	COMPLETED	Placebo BID Plus Standard of Care	13
Overall Study	COMPLETED	CCX168 10 mg BID Plus Standard of Care	12
Overall Study	COMPLETED	CCX168 30 mg BID Plus Standard of Care	15
Overall Study	NOT COMPLETED	Placebo BID Plus Standard of Care	0
Overall Study	NOT COMPLETED	CCX168 10 mg BID Plus Standard of Care	1
Overall Study	NOT COMPLETED	CCX168 30 mg BID Plus Standard of Care	1

Source ClinicalTrials.gov

Adverse events579

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
other	Oedema peripheral	General disorders	Placebo BID Plus Standard of Care	1	13
other	Oedema peripheral	General disorders	CCX168 10 mg BID Plus Standard of Care	2	13
other	Oedema peripheral	General disorders	CCX168 30 mg BID Plus Standard of Care	4	16
other	Fatigue	General disorders	Placebo BID Plus Standard of Care	3	13
other	Fatigue	General disorders	CCX168 10 mg BID Plus Standard of Care	2	13
other	Fatigue	General disorders	CCX168 30 mg BID Plus Standard of Care	1	16
other	Pain	General disorders	Placebo BID Plus Standard of Care	0	13
other	Pain	General disorders	CCX168 10 mg BID Plus Standard of Care	1	13
other	Pain	General disorders	CCX168 30 mg BID Plus Standard of Care	1	16
other	Vessel puncture site bruise	General disorders	Placebo BID Plus Standard of Care	1	13

1 to 10 of 579Source ClinicalTrials.gov

See all 579 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo BID Plus Standard of Care	0	13
Total, all-cause mortality	CCX168 10 mg BID Plus Standard of Care	0	13
Total, all-cause mortality	CCX168 30 mg BID Plus Standard of Care	0	16
Total, other adverse events	Placebo BID Plus Standard of Care	13	13
Total, other adverse events	CCX168 10 mg BID Plus Standard of Care	12	13
Total, other adverse events	CCX168 30 mg BID Plus Standard of Care	15	16
Total, serious adverse events	Placebo BID Plus Standard of Care	3	13
Total, serious adverse events	CCX168 10 mg BID Plus Standard of Care	2	13
Total, serious adverse events	CCX168 30 mg BID Plus Standard of Care	4	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33128347	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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