Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis (NCT NCT01363388)

Last Updated: 2025-03-13

Results Overview

Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Baseline to Day 85

Results posted on

2025-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo BID Plus 60 mg Prednisone Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone Drug: CCX168 30 mg BID without prednisone
Overall Study STARTED	23	22	22
Overall Study COMPLETED	18	19	18
Overall Study NOT COMPLETED	5	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Values provided for subjects with measurements at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo BID Plus 60 mg Prednisone n=23 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=22 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=22 Participants Drug: CCX168 30 mg BID without prednisone	Total n=67 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 14.0 • n=23 Participants	57.0 years STANDARD_DEVIATION 14.2 • n=22 Participants	57.4 years STANDARD_DEVIATION 14.0 • n=22 Participants	57.9 years STANDARD_DEVIATION 13.9 • n=67 Participants
Sex: Female, Male Female	6 Participants n=23 Participants	8 Participants n=22 Participants	6 Participants n=22 Participants	20 Participants n=67 Participants
Sex: Female, Male Male	17 Participants n=23 Participants	14 Participants n=22 Participants	16 Participants n=22 Participants	47 Participants n=67 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=23 Participants	22 Participants n=22 Participants	22 Participants n=22 Participants	67 Participants n=67 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) Asian	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) Black or African American	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) White	23 Participants n=23 Participants	22 Participants n=22 Participants	22 Participants n=22 Participants	67 Participants n=67 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=67 Participants
Smoking Status Current Smoker	3 Participants n=23 Participants	2 Participants n=22 Participants	4 Participants n=22 Participants	9 Participants n=67 Participants
Smoking Status Past Smoker	11 Participants n=23 Participants	6 Participants n=22 Participants	8 Participants n=22 Participants	25 Participants n=67 Participants
Smoking Status Never Smoked	9 Participants n=23 Participants	14 Participants n=22 Participants	10 Participants n=22 Participants	33 Participants n=67 Participants
BMI	27.3 kg/m^2 STANDARD_DEVIATION 7.09 • n=23 Participants • Values provided for subjects with measurements at baseline	24.9 kg/m^2 STANDARD_DEVIATION 4.05 • n=21 Participants • Values provided for subjects with measurements at baseline	26.5 kg/m^2 STANDARD_DEVIATION 4.66 • n=21 Participants • Values provided for subjects with measurements at baseline	26.3 kg/m^2 STANDARD_DEVIATION 5.49 • n=65 Participants • Values provided for subjects with measurements at baseline
ANCA disease status Newly diagnosed	18 Participants n=23 Participants	15 Participants n=22 Participants	16 Participants n=22 Participants	49 Participants n=67 Participants
ANCA disease status Relapsed	5 Participants n=23 Participants	7 Participants n=22 Participants	6 Participants n=22 Participants	18 Participants n=67 Participants
ANCA- associated vasculitis disease duration at screening	0.0 months n=23 Participants • Values provided for subjects with measurements at baseline	0.0 months n=22 Participants • Values provided for subjects with measurements at baseline	1.0 months n=21 Participants • Values provided for subjects with measurements at baseline	0.0 months n=66 Participants • Values provided for subjects with measurements at baseline
Background treatment Rituximab	3 Participants n=23 Participants	5 Participants n=22 Participants	5 Participants n=22 Participants	13 Participants n=67 Participants
Background treatment Cyclophosphamide	20 Participants n=23 Participants	17 Participants n=22 Participants	17 Participants n=22 Participants	54 Participants n=67 Participants
Type of AAV GPA	10 Participants n=23 Participants	11 Participants n=22 Participants	12 Participants n=22 Participants	33 Participants n=67 Participants
Type of AAV Microscopic polyangiitis	10 Participants n=23 Participants	9 Participants n=22 Participants	9 Participants n=22 Participants	28 Participants n=67 Participants
Type of AAV Renal-limited vasculitis	2 Participants n=23 Participants	2 Participants n=22 Participants	1 Participants n=22 Participants	5 Participants n=67 Participants
Type of AAV Unknown	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	1 Participants n=67 Participants
ANCA status categorical Anti-MPO positive	10 Participants n=23 Participants	12 Participants n=22 Participants	13 Participants n=22 Participants	35 Participants n=67 Participants
ANCA status categorical Anti-PR3 positive	11 Participants n=23 Participants	10 Participants n=22 Participants	8 Participants n=22 Participants	29 Participants n=67 Participants
ANCA status categorical Both anti-MPO positive and anti-PR3 positive	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	1 Participants n=67 Participants
ANCA status categorical ANCA equivocal	0 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=22 Participants	1 Participants n=67 Participants
ANCA status categorical ANCA negative	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=22 Participants	1 Participants n=67 Participants
BVAS total score	13.2 units on a scale STANDARD_DEVIATION 5.80 • n=23 Participants	14.3 units on a scale STANDARD_DEVIATION 5.98 • n=22 Participants	13.8 units on a scale STANDARD_DEVIATION 6.38 • n=22 Participants	13.7 units on a scale STANDARD_DEVIATION 5.98 • n=67 Participants
VDI score	1.2 units on a scale STANDARD_DEVIATION 1.35 • n=23 Participants	0.9 units on a scale STANDARD_DEVIATION 1.46 • n=22 Participants	0.5 units on a scale STANDARD_DEVIATION 1.19 • n=22 Participants	0.9 units on a scale STANDARD_DEVIATION 1.35 • n=67 Participants
Glomerular filtration rate (MDRD)	47.6 mL/min/1.73 m2 STANDARD_DEVIATION 15.08 • n=22 Participants • Values provided for subjects with measurements at baseline	52.5 mL/min/1.73 m2 STANDARD_DEVIATION 26.70 • n=22 Participants • Values provided for subjects with measurements at baseline	54.7 mL/min/1.73 m2 STANDARD_DEVIATION 19.64 • n=22 Participants • Values provided for subjects with measurements at baseline	51.6 mL/min/1.73 m2 STANDARD_DEVIATION 20.92 • n=66 Participants • Values provided for subjects with measurements at baseline
Albumin: creatinine ratio	353.9 mg/g n=22 Participants • Values provided for subjects with measurements at baseline	278.6 mg/g n=22 Participants • Values provided for subjects with measurements at baseline	283.4 mg/g n=21 Participants • Values provided for subjects with measurements at baseline	303.8 mg/g n=65 Participants • Values provided for subjects with measurements at baseline
Urinary MCP-1 : creatinine ratio	825.9 pg/mg creatinine n=23 Participants	1266.1 pg/mg creatinine n=22 Participants	846.4 pg/mg creatinine n=22 Participants	957.9 pg/mg creatinine n=67 Participants
Urinary red blood cells 30-49 per hpf	6 Participants n=23 Participants	4 Participants n=22 Participants	2 Participants n=22 Participants	12 Participants n=67 Participants
Urinary red blood cells 50-75 per hpf	5 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=22 Participants	12 Participants n=67 Participants
Urinary red blood cells >75 per hpf	3 Participants n=23 Participants	5 Participants n=22 Participants	3 Participants n=22 Participants	11 Participants n=67 Participants

PRIMARY outcome

Timeframe: Baseline to Day 85

Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component.

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=22 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=21 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Subjects Achieving Disease Response at Day 85	0.7 proportion of participants	0.86 proportion of participants	0.81 proportion of participants

SECONDARY outcome

Timeframe: Baseline to Day 85

Renal response, assessed in patients with hematuria and albuminuria at baseline, and defined as an improvement in renal parameters, i.e., an increase from baseline to Day 85 in eGFR (Estimated glomerular filtration rate), MDRD (Modification of Diet in Renal Disease), serum creatinine equation, a decrease from baseline to Day 85 in haematuria (central laboratory microscopic count of urinary red blood cells) , decrease from baseline to Day 85 in albuminuria count (first morning UACR (urinary albumin:creatinine ratio).

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=18 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=18 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Patients Achieving Renal Response at Day 85	0.4 proportion of participants	0.56 proportion of participants	0.33 proportion of participants

SECONDARY outcome

Timeframe: Day 85

Disease remission is defined as BVAS (Birmingham Vasculitis Activity Score) of 0 or 1 plus no worsening in eGFR (Estimated glomerular filtration rate) and urinary RBC (Red Blood cell) count \<10/high power field (hpf)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=22 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=21 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Subjects Achieving Disease Remission at Day 85	0.35 proportion of participants	0.27 proportion of participants	0.19 proportion of participants

SECONDARY outcome

Timeframe: Baseline to Day 85

Percent change in Burmingham Vasculitis Index Score (BVAS) at week 12, higher percentage change indicates worse outcome 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). A negative percentage change indicated improvement in health.

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=19 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=20 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=19 Participants Drug: CCX168 30 mg BID without prednisone
Percent Change From Baseline to Day 85 in BVAS	-56.45 percentage change Standard Deviation 62.100	-79.05 percentage change Standard Deviation 23.005	-73.01 percentage change Standard Deviation 29.464

SECONDARY outcome

Timeframe: Baseline to Day 85

eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=21 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=19 Participants Drug: CCX168 30 mg BID without prednisone
Change From Baseline to Day 85 in eGFR	5.55 ml/min/1.73 m^2 Standard Deviation 10.211	6.00 ml/min/1.73 m^2 Standard Deviation 10.469	0.79 ml/min/1.73 m^2 Standard Deviation 9.549

SECONDARY outcome

Timeframe: Baseline to Day 85

eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=21 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=19 Participants Drug: CCX168 30 mg BID without prednisone
Percent Change From Baseline to Day 85 in eGFR	15.36 percentage change Standard Deviation 23.685	19.91 percentage change Standard Deviation 23.034	0.92 percentage change Standard Deviation 20.562

SECONDARY outcome

Timeframe: Baseline to Day 85

In subjects with baseline hematuria \>5 RBCs/hpf (Red Blood Cell/High Power Field)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=19 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=18 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=18 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period	0.79 proportion of participants	0.61 proportion of participants	0.61 proportion of participants

SECONDARY outcome

Timeframe: Baseline to Day 85

In subjects with baseline hematuria \<=5 RBCs/hpf (Red Blood Cell/High Power Field)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=19 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=18 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=18 Participants Drug: CCX168 30 mg BID without prednisone
Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period	69.0 days Interval 28.0 to 84.0	69.0 days Interval 27.0 to Insufficient number of participants with events to estimate 75th quantile	42.0 days Interval 7.0 to Insufficient number of participants with events to estimate 75th quantile

SECONDARY outcome

Timeframe: Baseline to Day 85

In subjects with baseline hematuria \>=30 RBCs/hpf,(Red Blood Cell/High Power Field)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=12 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=13 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=7 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period	11 Participants	13 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline to Day 85

In subjects with baseline hematuria \<=30 RBCs/hpf (Red Blood Cell/High Power Field)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=11 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=13 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=7 Participants Drug: CCX168 30 mg BID without prednisone
Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period	10.5 days Interval 1.0 to 35.0	21.0 days Interval 7.0 to 42.0	42.0 days Interval 1.0 to Insufficient number of participants with events to estimate 75th quantile

SECONDARY outcome

Timeframe: Baseline to day 85

In subjects with hematuria at baseline, RBC (Red Blood Cell)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=19 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=17 Participants Drug: CCX168 30 mg BID without prednisone
Percent Change From Baseline to Day 85 in Urinary RBC Count	-72.37 percentage change Interval -99.4 to 66.7	1.63 percentage change Interval -99.7 to 1150.0	-21.26 percentage change Interval -99.4 to 368.8

SECONDARY outcome

Timeframe: Baseline to Day 85

In subjects with albuminuria at baseline UACR (urinary albumin:creatinine ratio)

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=20 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=18 Participants Drug: CCX168 30 mg BID without prednisone
Percent Change From Baseline to Day 85 in UACR	-3.10 percentage change Interval -71.1 to 131.7	-34.18 percentage change Interval -89.2 to 173.1	-15.21 percentage change Interval -85.9 to 360.3

SECONDARY outcome

Timeframe: Baseline to Day 85

Urinary Monocyte Chemoattractant Protein-1 (MCP-1):creatinine ratio

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=20 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=19 Participants Drug: CCX168 30 mg BID without prednisone
Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio	-37.57 percentage change Interval -72.7 to 41.0	-59.29 percentage change Interval -93.6 to 60.1	-39.44 percentage change Interval -90.7 to 59.0

SECONDARY outcome

Timeframe: Baseline to Day 85

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=11 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=9 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=8 Participants Drug: CCX168 30 mg BID without prednisone
Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment	0 proportion of participants	0.33 proportion of participants	0.13 proportion of participants

SECONDARY outcome

Timeframe: Baseline to Day 85

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).

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=20 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=20 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=19 Participants Drug: CCX168 30 mg BID without prednisone
Change From Baseline to Day 85 in the Vasculitis Damage Index	0.7 score on a scale Standard Deviation 0.81	0.3 score on a scale Standard Deviation 0.57	0.2 score on a scale Standard Deviation 0.54

SECONDARY outcome

Timeframe: Baseline, Day 29 & Day 85

Population: Number of subjects with data at baseline and the specified visit are specified.

SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).

Outcome measures

SECONDARY outcome

Timeframe: Baseline, Day 29 and Day 85

Population: Number of subjects with data at baseline and the specified visit are specified.

EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).

Outcome measures

Outcome measures
Measure	Placebo BID Plus 60 mg Prednisone n=9 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=13 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=9 Participants Drug: CCX168 30 mg BID without prednisone
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L VAS Score (Day 29)	-2.4 Change from baseline score on a scale Standard Deviation 10.61	6.5 Change from baseline score on a scale Standard Deviation 17.96	4.5 Change from baseline score on a scale Standard Deviation 12.62
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L VAS Score (Day 85)	-3.3 Change from baseline score on a scale Standard Deviation 13.23	11.8 Change from baseline score on a scale Standard Deviation 17.61	4.0 Change from baseline score on a scale Standard Deviation 4.69
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L Index Score (Day 29)	-0.044 Change from baseline score on a scale Standard Deviation 0.1597	0.034 Change from baseline score on a scale Standard Deviation 0.1111	-0.057 Change from baseline score on a scale Standard Deviation 0.0952
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L Index Score (Day 85)	-0.043 Change from baseline score on a scale Standard Deviation 0.1718	0.067 Change from baseline score on a scale Standard Deviation 0.1314	-0.047 Change from baseline score on a scale Standard Deviation 0.0721

Adverse Events

Placebo BID Plus 60 mg Prednisone

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

CCX168 30 mg BID Plus 20 mg Prednisone

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

CCX168 30 mg BID Without Prednisone

Serious events: 10 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

ChemoCentryx

Phone: 650-210-2900

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo BID Plus 60 mg Prednisone n=10 Participants Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=14 Participants Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=8 Participants Drug: CCX168 30 mg BID without prednisone
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Role Physical (Day 29)	9.7 Change from baseline score on a scale Standard Error 10.73	13.8 Change from baseline score on a scale Standard Error 7.61	8.6 Change from baseline score on a scale Standard Error 6.02
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Role Physical (Day 85)	13.7 Change from baseline score on a scale Standard Error 11.06	36.1 Change from baseline score on a scale Standard Error 9.28	16.1 Change from baseline score on a scale Standard Error 9.24
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Bodily pain (Day 29)	3.1 Change from baseline score on a scale Standard Error 10.63	17.3 Change from baseline score on a scale Standard Error 8.42	5.1 Change from baseline score on a scale Standard Error 16.75
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 General Health Perceptions (Day 85)	5.7 Change from baseline score on a scale Standard Error 6.05	2.3 Change from baseline score on a scale Standard Error 3.93	-1.5 Change from baseline score on a scale Standard Error 5.51
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Vitality (Day 85)	4.36 Change from baseline score on a scale Standard Error 6.457	22.28 Change from baseline score on a scale Standard Error 7.541	10.71 Change from baseline score on a scale Standard Error 5.893
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Social Functioning (Day 29)	-2.8 Change from baseline score on a scale Standard Error 11.74	24.1 Change from baseline score on a scale Standard Error 6.07	-7.8 Change from baseline score on a scale Standard Error 6.22
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Mental Health (Day 85)	-1.0 Change from baseline score on a scale Standard Error 4.88	16.5 Change from baseline score on a scale Standard Error 4.65	2.1 Change from baseline score on a scale Standard Error 4.86
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Physical Functioning (Day 29)	5.0 Change from baseline score on a scale Standard Error 6.18	7.0 Change from baseline score on a scale Standard Error 6.90	8.2 Change from baseline score on a scale Standard Error 11.46
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Role-Emotional (Day 29)	1.9 Change from baseline score on a scale Standard Error 9.08	20.3 Change from baseline score on a scale Standard Error 8.04	-1.1 Change from baseline score on a scale Standard Error 8.97
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Role-Emotional (Day 85)	0.0 Change from baseline score on a scale Standard Error 10.98	21.8 Change from baseline score on a scale Standard Error 9.42	10.7 Change from baseline score on a scale Standard Error 8.27
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Physical Component Summary (Day 29)	2.693 Change from baseline score on a scale Standard Error 3.436	4.074 Change from baseline score on a scale Standard Error 2.601	2.826 Change from baseline score on a scale Standard Error 4.526
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Physical Component Summary (Day 85)	5.383 Change from baseline score on a scale Standard Error 2.694	6.744 Change from baseline score on a scale Standard Error 3.132	4.863 Change from baseline score on a scale Standard Error 2.415
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Mental Health Summary (Day 29)	0.303 Change from baseline score on a scale Standard Error 3.120	10.855 Change from baseline score on a scale Standard Error 3.244	-4.760 Change from baseline score on a scale Standard Error 3.266
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Mental Health Summary (Day 85)	-0.766 Change from baseline score on a scale Standard Error 3.888	11.779 Change from baseline score on a scale Standard Error 3.428	2.197 Change from baseline score on a scale Standard Error 1.066
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Bodily pain (Day 85)	12.8 Change from baseline score on a scale Standard Error 7.36	21.7 Change from baseline score on a scale Standard Error 9.54	14.0 Change from baseline score on a scale Standard Error 9.30
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 General Health Perceptions (Day 29)	2.5 Change from baseline score on a scale Standard Error 8.26	3.7 Change from baseline score on a scale Standard Error 4.60	-13.7 Change from baseline score on a scale Standard Error 10.21
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Vitality (Day 29)	7.63 Change from baseline score on a scale Standard Error 6.403	12.98 Change from baseline score on a scale Standard Error 7.400	-0.78 Change from baseline score on a scale Standard Error 3.630
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Social Functioning (Day 85)	6.3 Change from baseline score on a scale Standard Error 9.90	35.6 Change from baseline score on a scale Standard Error 6.91	5.4 Change from baseline score on a scale Standard Error 3.72
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Mental Health (Day 29)	1.7 Change from baseline score on a scale Standard Error 2.20	10.8 Change from baseline score on a scale Standard Error 3.71	-8.1 Change from baseline score on a scale Standard Error 6.88
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Reported Health Transition (Day 29)	0.2 Change from baseline score on a scale Standard Error 0.22	-0.6 Change from baseline score on a scale Standard Error 0.41	0.3 Change from baseline score on a scale Standard Error 0.31
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Reported Health Transition (Day 85)	0.0 Change from baseline score on a scale Standard Error 0.37	-1.2 Change from baseline score on a scale Standard Error 0.48	-0.4 Change from baseline score on a scale Standard Error 0.48
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 SF-36 Physical Functioning (Day 85)	5.2 Change from baseline score on a scale Standard Error 7.00	13.5 Change from baseline score on a scale Standard Error 7.73	11.4 Change from baseline score on a scale Standard Error 8.43

Measure	Placebo BID Plus 60 mg Prednisone n=23 participants at risk Drug: Placebo BID plus 60 mg prednisone	CCX168 30 mg BID Plus 20 mg Prednisone n=22 participants at risk Drug: CCX168 30 mg BID plus 20 mg prednisone	CCX168 30 mg BID Without Prednisone n=22 participants at risk Drug: CCX168 30 mg BID without prednisone
Eye disorders Ocular Hyperaemia	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
General disorders Pyrexia	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Immune system disorders Hypersensitivity	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Infections and infestations Febrile Infection	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Infections and infestations Lung Infection	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Infections and infestations Pneumonia	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Infections and infestations Respiratory Tract Infection	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	9.1% 2/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Infections and infestations Viral Infection	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Investigations C-Reactive Protein Increased	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Investigations Hepatic Enzyme Increased	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Investigations Pancreatic Enzyme Increased	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Musculoskeletal and connective tissue disorders Back Pain	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Renal and urinary disorders Haematuria	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Renal and urinary disorders Renal Impairement	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Renal and urinary disorders Renal Vasculitis	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Vascular disorders Microscopic Polyangiitis	0.00% 0/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	0.00% 0/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	4.5% 1/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication
Vascular disorders Vasculitius	4.3% 1/23 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	9.1% 2/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication	9.1% 2/22 • 168 Day Treatment Period An adverse event is considered treatment-emergent if the start date of the event is on or after administration of the first dose of study medication