Trial Outcomes & Findings for Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis (NCT NCT02222155)

NCT ID: NCT02222155

Last Updated: 2025-03-13

Results Overview

This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Baseline to Day 85

Results posted on

2025-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo BID Plus Standard of Care Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Overall Study STARTED	13	13	16
Overall Study COMPLETED	13	12	15
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only participants with values at baseline have been recorded

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=13 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=16 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	Total n=42 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 15.42 • n=13 Participants	60.0 years STANDARD_DEVIATION 10.17 • n=13 Participants	55.3 years STANDARD_DEVIATION 13.81 • n=16 Participants	57.7 years STANDARD_DEVIATION 13.18 • n=42 Participants
Sex: Female, Male Female	9 Participants n=13 Participants	5 Participants n=13 Participants	9 Participants n=16 Participants	23 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=13 Participants	8 Participants n=13 Participants	7 Participants n=16 Participants	19 Participants n=42 Participants
Race Black or African American	0 Participants n=13 Participants	2 Participants n=13 Participants	1 Participants n=16 Participants	3 Participants n=42 Participants
Race White	13 Participants n=13 Participants	11 Participants n=13 Participants	14 Participants n=16 Participants	38 Participants n=42 Participants
Race Other	0 Participants n=13 Participants	0 Participants n=13 Participants	1 Participants n=16 Participants	1 Participants n=42 Participants
Ethnicity Hispanic or Latino	0 Participants n=13 Participants	1 Participants n=13 Participants	2 Participants n=16 Participants	3 Participants n=42 Participants
Ethnicity Not Hispanic or Latino	13 Participants n=13 Participants	12 Participants n=13 Participants	14 Participants n=16 Participants	39 Participants n=42 Participants
Smoking status Current smoker	1 Participants n=13 Participants	1 Participants n=13 Participants	0 Participants n=16 Participants	2 Participants n=42 Participants
Smoking status Past smoker	5 Participants n=13 Participants	5 Participants n=13 Participants	6 Participants n=16 Participants	16 Participants n=42 Participants
Smoking status Never smoked	7 Participants n=13 Participants	7 Participants n=13 Participants	10 Participants n=16 Participants	24 Participants n=42 Participants
BMI	31.0 kg/m^2 STANDARD_DEVIATION 12.51 • n=13 Participants	27.6 kg/m^2 STANDARD_DEVIATION 8.91 • n=13 Participants	31.5 kg/m^2 STANDARD_DEVIATION 7.59 • n=16 Participants	30.2 kg/m^2 STANDARD_DEVIATION 9.65 • n=42 Participants
ANCA disease status Newly diagnosed	8 Participants n=13 Participants	10 Participants n=13 Participants	9 Participants n=16 Participants	27 Participants n=42 Participants
ANCA disease status Relapsed	5 Participants n=13 Participants	3 Participants n=13 Participants	7 Participants n=16 Participants	15 Participants n=42 Participants
ANCA-associated vasculitis disease duration at screening (months)	1.0 months n=13 Participants	1.0 months n=13 Participants	2.5 months n=16 Participants	1.0 months n=42 Participants
Background treatment Rituximab	12 Participants n=13 Participants	13 Participants n=13 Participants	14 Participants n=16 Participants	39 Participants n=42 Participants
Background treatment Cyclophosphamide	1 Participants n=13 Participants	0 Participants n=13 Participants	2 Participants n=16 Participants	3 Participants n=42 Participants
Type of AAV GPA	9 Participants n=13 Participants	8 Participants n=13 Participants	12 Participants n=16 Participants	29 Participants n=42 Participants
Type of AAV Microscopic polyangiitis	3 Participants n=13 Participants	4 Participants n=13 Participants	4 Participants n=16 Participants	11 Participants n=42 Participants
Type of AAV Renal-limited vasculitis	1 Participants n=13 Participants	1 Participants n=13 Participants	0 Participants n=16 Participants	2 Participants n=42 Participants
ANCA positivity stratification status Anti-MPO positive	7 Participants n=13 Participants	6 Participants n=13 Participants	8 Participants n=16 Participants	21 Participants n=42 Participants
ANCA positivity stratification status Anti-PR3 positive	6 Participants n=13 Participants	7 Participants n=13 Participants	8 Participants n=16 Participants	21 Participants n=42 Participants
BVAS	15.0 score on a scale STANDARD_DEVIATION 4.45 • n=13 Participants	15.8 score on a scale STANDARD_DEVIATION 8.84 • n=13 Participants	15.1 score on a scale STANDARD_DEVIATION 6.43 • n=16 Participants	15.3 score on a scale STANDARD_DEVIATION 6.63 • n=42 Participants
VDI score	1.2 score on a scale STANDARD_DEVIATION 1.77 • n=13 Participants	0.8 score on a scale STANDARD_DEVIATION 2.49 • n=13 Participants	0.6 score on a scale STANDARD_DEVIATION 1.15 • n=16 Participants	0.8 score on a scale STANDARD_DEVIATION 1.81 • n=42 Participants
Estimated glomerular filtration rate	60.1 mL/min/1.73 m^2 STANDARD_DEVIATION 24.25 • n=13 Participants	56.4 mL/min/1.73 m^2 STANDARD_DEVIATION 26.75 • n=13 Participants	61.4 mL/min/1.73 m^2 STANDARD_DEVIATION 31.09 • n=16 Participants	59.4 mL/min/1.73 m^2 STANDARD_DEVIATION 27.20 • n=42 Participants
Albumin:creatinine ratio	135.4 mg/g n=12 Participants • Only participants with values at baseline have been recorded	76.1 mg/g n=13 Participants • Only participants with values at baseline have been recorded	111.9 mg/g n=16 Participants • Only participants with values at baseline have been recorded	104.7 mg/g n=41 Participants • Only participants with values at baseline have been recorded
Urinary MCP-1:creatinine ratio	651.7 pg/mg creatinine n=11 Participants • Only participants with values at baseline have been recorded	499.0 pg/mg creatinine n=11 Participants • Only participants with values at baseline have been recorded	463.5 pg/mg creatinine n=16 Participants • Only participants with values at baseline have been recorded	522.6 pg/mg creatinine n=38 Participants • Only participants with values at baseline have been recorded
Urinary RBCs 30-49 per hpf	1 Participants n=13 Participants	1 Participants n=13 Participants	1 Participants n=16 Participants	3 Participants n=42 Participants
Urinary RBCs 50-75 per hpf	1 Participants n=13 Participants	1 Participants n=13 Participants	0 Participants n=16 Participants	2 Participants n=42 Participants
Urinary RBCs >75 per hpf	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=16 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline to Day 85

Population: Safety population: The Safety Population included all subjects who were randomized and received at least 1 dose of study drug

This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=13 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=16 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Incidence of Adverse Events	13 Participants	11 Participants	15 Participants

PRIMARY outcome

Timeframe: Day 85

Population: 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 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

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=12 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=15 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	0.85 proportion of participants	0.92 proportion of participants	0.8 proportion of participants

SECONDARY outcome

Timeframe: Day 85

Population: 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 subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=12 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=15 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	0.54 proportion of participants	0.67 proportion of participants	0.47 proportion of participants

SECONDARY outcome

Timeframe: Day 29 and 85

Population: 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 subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=12 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=15 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.	0.15 proportion of participants	0.08 proportion of participants	0.2 proportion of participants

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=11 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=14 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Percent Change From Baseline to Day 85 in BVAS.	-81.8 percentage change from baseline Standard Deviation 23.30	-95.6 percentage change from baseline Standard Deviation 8.03	-81.7 percentage change from baseline Standard Deviation 31.28

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=6 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=5 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=8 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85	0.17 proportion of participants	0.4 proportion of participants	0.63 proportion of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=9 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=8 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=10 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Change in Estimated Glomerular Filtration Rate at Day 85	2.0 ml/min/1.73 m^2 Standard Deviation 10.71	1.3 ml/min/1.73 m^2 Standard Deviation 9.75	6.2 ml/min/1.73 m^2 Standard Deviation 22.17

SECONDARY outcome

Timeframe: Baseline to Day 85

Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=9 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=8 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=10 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Percentage Change in Estimated Glomerular Filtration Rate at Day 85	6.2 % change from baseline (ml/min/1.73 m²) Standard Deviation 35.65	0.9 % change from baseline (ml/min/1.73 m²) Standard Deviation 17.63	7.7 % change from baseline (ml/min/1.73 m²) Standard Deviation 27.92

SECONDARY outcome

Timeframe: Baseline to Day 85

Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline.

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=7 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=5 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=8 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85	-56.3 percentage change from baseline Interval -99.67 to 100.0	-31.5 percentage change from baseline Interval -99.0 to 233.33	-95.0 percentage change from baseline Interval -99.38 to -81.25

SECONDARY outcome

Timeframe: Baseline to Day 85

Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=9 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=8 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=10 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85	-66.281 percentage change from baseline Interval -92.31 to -40.4	-13.890 percentage change from baseline Interval -92.86 to 175.56	-57.596 percentage change from baseline Interval -96.1 to 6.03

SECONDARY outcome

Timeframe: Baseline to Day 85

Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=11 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=9 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=14 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85	-33.175 percentage change from baseline Interval -85.2 to 106.45	-34.802 percentage change from baseline Interval -87.27 to 68.48	63.567 percentage change from baseline Interval -81.63 to 1023.16

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: 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.

The Vasculitis Damage Index (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 Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=11 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=14 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Change From Baseline to Day 85 in the VDI	0.31 score on a scale Standard Deviation 0.751	0.09 score on a scale Standard Deviation 0.302	0.14 score on a scale Standard Deviation 0.363

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: 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. \*p\<0.05 for CCX168 compared to control for change or percent change from baseline.

Change from Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the Short Form-36 (SF-36v2) 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

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=11 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=14 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Role - physical	4.1 score on a scale Standard Error 11.44	16.1 score on a scale Standard Error 13.58	9.6 score on a scale Standard Error 10.15
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Reported health transition	-0.7 score on a scale Standard Error 0.48	-1.1 score on a scale Standard Error 0.58	-1.6 score on a scale Standard Error 0.44
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Physical functioning	4.9 score on a scale Standard Error 7.51	13.5 score on a scale Standard Error 8.33	17.2 score on a scale Standard Error 6.61
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Role - emotional	8.4 score on a scale Standard Error 7.76	10.8 score on a scale Standard Error 8.42	12.7 score on a scale Standard Error 6.80
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Bodily pain	-3.5 score on a scale Standard Error 8.40	11.0 score on a scale Standard Error 9.58	14.9 score on a scale Standard Error 7.85
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 General health perceptions	-12.6 score on a scale Standard Error 4.97	-3.8 score on a scale Standard Error 5.61	-6.6 score on a scale Standard Error 4.49
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Vitality	-2.5 score on a scale Standard Error 8.09	13.8 score on a scale Standard Error 9.31	11.8 score on a scale Standard Error 7.38
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Social functioning	4.4 score on a scale Standard Error 7.81	15.2 score on a scale Standard Error 8.96	0.5 score on a scale Standard Error 7.12
Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 SF-36 Mental health	8.2 score on a scale Standard Error 5.49	13.3 score on a scale Standard Error 5.80	12.6 score on a scale Standard Error 4.66

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: 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.

Mean Change from baseline to Day 85 in health-related quality-of-life as measured by the Euro Quality-of-Life-5 Domains-5 Levels (EQ-5D-5L). 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 Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=11 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=14 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L EQ-5D-5L VAS Score	12.85 score on scale Standard Deviation 25.413	20.18 score on scale Standard Deviation 18.121	11.21 score on scale Standard Deviation 21.641
Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L EQ-5D-5L Index Score	0.03 score on scale Standard Deviation 0.140	0.05 score on scale Standard Deviation 0.200	0.04 score on scale Standard Deviation 0.138

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: 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 subjects requiring rescue glucocorticoid treatment from Baseline to Day 85

Outcome measures

Outcome measures
Measure	Placebo BID Plus Standard of Care n=13 Participants Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=13 Participants Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=16 Participants Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85	0 proportion of participants	0 proportion of participants	0 proportion of participants

Adverse Events

Placebo BID Plus Standard of Care

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

CCX168 10 mg BID Plus Standard of Care

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

CCX168 30 mg BID Plus Standard of Care

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo BID Plus Standard of Care n=13 participants at risk Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 10 mg BID Plus Standard of Care n=13 participants at risk Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	CCX168 30 mg BID Plus Standard of Care n=16 participants at risk Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
Blood and lymphatic system disorders Methemoglobinemia	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Infections and infestations Gangrene	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Infections and infestations Cellulitis staphylococcal	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
General disorders Abscess limb	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
General disorders Perirectal abscess	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Cardiac disorders Atrial fibrillation	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	6.2% 1/16 • Number of events 2 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Infections and infestations Sepsis	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	6.2% 1/16 • Number of events 2 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Renal and urinary disorders Urinary tract infection	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	6.2% 1/16 • Number of events 2 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Renal and urinary disorders Renal failure acute	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	6.2% 1/16 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Renal and urinary disorders Nephrolithiasis	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Bronchiolitis	7.7% 1/13 • Number of events 1 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/13 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug	0.00% 0/16 • Baseline to day 169 The Safety Population included all subjects who were randomized and received at least 1 dose of study drug

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