Trial Outcomes & Findings for A Study of CCX140-B in Subjects With FSGS (NCT NCT03536754)

NCT ID: NCT03536754

Last Updated: 2025-03-13

Results Overview

Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2025-03-13

Participant Flow

The recruitment took place in Australia, Canada, France, Italy, New Zealand, Poland, United Kingdom, and in the United States. The target was to enroll 40 male or female subjects. The first patient was enrolled on 17 May 2018. A total of 84 subjects were screened; 38 subjects failed screening and 46 subjects were randomized.

Eighty-four (84) patients were screened. Screen failure occurred in 38 (45.2%) subjects due to not meeting inclusion or exclusion criteria (35 [41.7%] subjects) and other reasons (3 [3.6%] subjects).

Participant milestones

Measure	Placebo Placebo: Placebo	CCX140-B 5 mg Once Daily CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Double Blind Period 1 STARTED	12	11	12	11	0
Double Blind Period 1 COMPLETED	12	11	11	11	0
Double Blind Period 1 NOT COMPLETED	0	0	1	0	0
Open Label Extension STARTED	0	0	0	0	43
Open Label Extension COMPLETED	0	0	0	0	42
Open Label Extension NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Measure	Placebo Placebo: Placebo	CCX140-B 5 mg Once Daily CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Double Blind Period 1 Withdrawal by Subject	0	0	1	0	0
Open Label Extension Other	0	0	0	0	1

Baseline Characteristics

A Study of CCX140-B in Subjects With FSGS

Baseline characteristics by cohort

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=12 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	44 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 12.50 • n=5 Participants	41.7 years STANDARD_DEVIATION 12.70 • n=7 Participants	37.9 years STANDARD_DEVIATION 15.51 • n=5 Participants	43.4 years STANDARD_DEVIATION 13.26 • n=4 Participants	42.3 years STANDARD_DEVIATION 13.47 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	41 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
UPCR at screening UPCR ≥ 3.5 at screening	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
UPCR at screening UPCR < 3.5 at screening	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	35 Participants n=21 Participants
UPCR at baseline UPCR ≥ 3.5 at baseline	1 g/dL n=5 Participants	1 g/dL n=7 Participants	3 g/dL n=5 Participants	4 g/dL n=4 Participants	9 g/dL n=21 Participants
UPCR at baseline UPCR < 3.5 at baseline	11 g/dL n=5 Participants	10 g/dL n=7 Participants	9 g/dL n=5 Participants	7 g/dL n=4 Participants	37 g/dL n=21 Participants
Concomitant use of ACE inhibitor or ARB or aldosterone antagonists Yes	12 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	43 Participants n=21 Participants
Concomitant use of ACE inhibitor or ARB or aldosterone antagonists No	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Current use of glucocorticoids and/or immunosuppressive medications Yes	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Current use of glucocorticoids and/or immunosuppressive medications No	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Concomitant use of glucocorticoids Yes	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Concomitant use of glucocorticoids No	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Concomitant use of all calcineurin inhibitors combined Yes	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Concomitant use of all calcineurin inhibitors combined No	10 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	34 Participants n=21 Participants
Concomitant use of calcineurin inhibitors cyclosporin Yes	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Concomitant use of calcineurin inhibitors cyclosporin No	11 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	40 Participants n=21 Participants
UPCR	2.19 g protein/g creatinine STANDARD_DEVIATION 1.029 • n=5 Participants	2.00 g protein/g creatinine STANDARD_DEVIATION 1.149 • n=7 Participants	2.86 g protein/g creatinine STANDARD_DEVIATION 2.008 • n=5 Participants	3.12 g protein/g creatinine STANDARD_DEVIATION 2.504 • n=4 Participants	2.54 g protein/g creatinine STANDARD_DEVIATION 1.773 • n=21 Participants
Baseline eGFR (CKD-EPI Creatinine-Cystatin C)	72.75 ml/min/1.73 m^2 STANDARD_DEVIATION 36.204 • n=5 Participants	56.18 ml/min/1.73 m^2 STANDARD_DEVIATION 28.927 • n=7 Participants	54.67 ml/min/1.73 m^2 STANDARD_DEVIATION 15.622 • n=5 Participants	61.36 ml/min/1.73 m^2 STANDARD_DEVIATION 32.265 • n=4 Participants	61.35 ml/min/1.73 m^2 STANDARD_DEVIATION 29.163 • n=21 Participants
Baseline urine MCP-1 creatinine ratio	453.74 g protein/g creatinine STANDARD_DEVIATION 438.384 • n=5 Participants	576.41 g protein/g creatinine STANDARD_DEVIATION 470.089 • n=7 Participants	504.02 g protein/g creatinine STANDARD_DEVIATION 388.569 • n=5 Participants	430.66 g protein/g creatinine STANDARD_DEVIATION 325.651 • n=4 Participants	490.67 g protein/g creatinine STANDARD_DEVIATION 399.559 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in UPCR at Week 12	0.83 g protein/g creatinine Interval 0.69 to 0.99	1.02 g protein/g creatinine Interval 0.84 to 1.23	1.12 g protein/g creatinine Interval 0.93 to 1.35	0.87 g protein/g creatinine Interval 0.72 to 1.05	—

PRIMARY outcome

Timeframe: Baseline to Week 12, and Week 12 to Week 24

TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=12 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=43 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) TEAEs leading to study withdrawal	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) TEAEs	10 Participants	6 Participants	8 Participants	7 Participants	24 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Population: Data is not available for all participants.

Normal Range: 23.9 - 40.0

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=10 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=10 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=40 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Activated Partial Thromboplastin Time Week 12	2.40 second Standard Deviation 4.259	2.05 second Standard Deviation 4.396	2.36 second Standard Deviation 2.614	1.28 second Standard Deviation 2.508	1.76 second Standard Deviation 4.332
Change From Baseline in Activated Partial Thromboplastin Time Week 24	2.91 second Standard Deviation 4.132	1.39 second Standard Deviation 3.187	2.34 second Standard Deviation 6.169	0.10 second Standard Deviation 3.223	1.76 second Standard Deviation 4.332

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal Range: 6 - 41 U/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Alanine Aminotransferase	0.5 U/L Standard Deviation 2.70	0.8 U/L Standard Deviation 5.22	0.3 U/L Standard Deviation 3.29	-1.8 U/L Standard Deviation 2.95	0.0 U/L Standard Deviation 3.65

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Alkaline Phosphatase	10.2 U/L Standard Deviation 7.08	-1.0 U/L Standard Deviation 11.59	0.7 U/L Standard Deviation 15.86	-1.9 U/L Standard Deviation 9.45	2.3 U/L Standard Deviation 12.16

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 22-123 U/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Amylase	3.1 U/L Standard Deviation 16.11	8.9 U/L Standard Deviation 18.30	5.0 U/L Standard Deviation 24.56	3.9 U/L Standard Deviation 23.19	5.2 U/L Standard Deviation 20.09

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range : 9-34 U/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Aspartate Aminotransferase	18.3 U/L Standard Deviation 6.17	-0.4 U/L Standard Deviation 4.60	-3.5 U/L Standard Deviation 7.71	-3.2 U/L Standard Deviation 3.07	-1.7 U/L Standard Deviation 5.25

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 21-33 mmol/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Bicarbonate	0.5 mmol/L Standard Deviation 3.45	-0.4 mmol/L Standard Deviation 3.24	0.9 mmol/L Standard Deviation 3.59	-0.6 mmol/L Standard Deviation 2.83	0.1 mmol/L Standard Deviation 3.24

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.1-1.10 mg/dL

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Bilirubin	0.044 mg/dL Standard Deviation 0.1985	-0.006 mg/dL Standard Deviation 0.2796	0.160 mg/dL Standard Deviation 0.2381	-0.012 mg/dL Standard Deviation 0.1519	0.050 mg/dL Standard Deviation 0.2263

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.0-3.0 mg/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma C Reactive Protein	1.200 mg/L Standard Deviation 3.1597	2.144 mg/L Standard Deviation 8.5528	-1.000 mg/L Standard Deviation 4.6448	-1.444 mg/L Standard Deviation 3.8014	0.260 mg/L Standard Deviation 5.4276

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 8.5-10.5 mg/dL

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Calcium	0.18 mg/dL Standard Deviation 0.387	0.20 mg/dL Standard Deviation 0.427	0.17 mg/dL Standard Deviation 0.498	-0.01 mg/dL Standard Deviation 0.454	0.14 mg/dL Standard Deviation 0.434

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 95-110 mmol/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Chloride	-0.5 mmol/L Standard Deviation 2.70	0.9 mmol/L Standard Deviation 1.79	-0.8 mmol/L Standard Deviation 3.31	3.2 mmol/L Standard Deviation 2.33	0.6 mmol/L Standard Deviation 2.97

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 100-200 mg/dL

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Cholesterol	-2.7 mg/dL Standard Deviation 31.11	-2.0 mg/dL Standard Deviation 27.67	18.9 mg/dL Standard Deviation 48.17	-43.0 mg/dL Standard Deviation 64.17	-5.6 mg/dL Standard Deviation 47.99

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 23-210 U/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Creatine Kinase	21.2 U/L Standard Deviation 39.65	18.1 U/L Standard Deviation 59.20	-19.5 U/L Standard Deviation 89.93	14.2 U/L Standard Deviation 206.95	11.9 U/L Standard Deviation 89.15

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.62-1.44 mg/dL

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Creatinine	0.060 mg/dL Standard Deviation 0.1437	0.033 mg/dL Standard Deviation 0.2461	0.115 mg/dL Standard Deviation 0.2186	0.147 mg/dL Standard Deviation 0.3790	0.161 mg/dL Standard Deviation 0.3926

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.53-0.95 mg/L

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Cystatin C	0.114 mg/L Standard Deviation 0.1838	0.104 mg/L Standard Deviation 0.1074	0.093 mg/L Standard Deviation 0.2896	0.018 mg/L Standard Deviation 0.2198	0.087 mg/L Standard Deviation 0.2436

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Direct Bilirubin	0.011 mg/dL Standard Deviation 0.0396	0.008 mg/dL Standard Deviation 0.0316	0.005 mg/dL Standard Deviation 0.0497	-0.005 mg/dL Standard Deviation 0.0254	0.004 mg/dL Standard Deviation 0.0373

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=11 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=40 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Glucose	-5.3 mg/dL Standard Deviation 15.11	1.1 mg/dL Standard Deviation 10.58	1.5 mg/dL Standard Deviation 16.91	-6.2 mg/dL Standard Deviation 14.07	-0.9 mg/dL Standard Deviation 14.27

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

HDL -High-density lipoprotein

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma HDL Cholesterol	0.8 mg/dL Standard Deviation 5.75	-2.3 mg/dL Standard Deviation 12.95	2.1 mg/dL Standard Deviation 20.41	2.4 mg/dL Standard Deviation 9.65	0.7 mg/dL Standard Deviation 9.39

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Indirect Bilirubin	0.043 mg/dL Standard Deviation 0.1033	-0.009 mg/dL Standard Deviation 0.0919	0.054 mg/dL Standard Deviation 0.2866	-0.043 mg/dL Standard Deviation 0.1572	0.046 mg/dL Standard Deviation 0.1947

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

LDL - Low-density lipoprotein

Outcome measures

Measure	Placebo n=10 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=10 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=38 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma LDL Cholesterol	12.2 mg/dL Standard Deviation 19.97	-2.8 mg/dL Standard Deviation 11.36	8.0 mg/dL Standard Deviation 24.86	-8.9 mg/dL Standard Deviation 37.78	-5.0 mg/dL Standard Deviation 37.61

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Lactate Dehydrogenase	-10.2 U/L Standard Deviation 25.67	-26.4 U/L Standard Deviation 69.73	-14.5 U/L Standard Deviation 26.09	5.1 U/L Standard Deviation 27.15	-12.0 U/L Standard Deviation 41.83

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Pancreatic Lipase	3.6 U/L Standard Deviation 9.71	8.1 U/L Standard Deviation 24.14	-5.2 U/L Standard Deviation 9.81	24.5 U/L Standard Deviation 51.50	9.0 U/L Standard Deviation 50.27

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Magnesium	0.10 mg/dL Standard Deviation 0.148	0.02 mg/dL Standard Deviation 0.140	-0.02 mg/dL Standard Deviation 0.240	0.09 mg/dL Standard Deviation 0.321	0.01 mg/dL Standard Deviation 0.199

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Phosphate	0.33 mg/dL Standard Deviation 0.609	0.16 mg/dL Standard Deviation 0.423	0.15 mg/dL Standard Deviation 0.596	0.04 mg/dL Standard Deviation 0.803	0.04 mg/dL Standard Deviation 0.580

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=11 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=38 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Potassium	0.09 mmol/L Standard Deviation 0.327	0.12 mmol/L Standard Deviation 0.232	-0.09 mmol/L Standard Deviation 0.305	0.23 mmol/L Standard Deviation 0.789	0.00 mmol/L Standard Deviation 0.514

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Protein	0.17 g/dL Standard Deviation 0.320	0.05 g/dL Standard Deviation 0.305	-0.11 g/dL Standard Deviation 0.575	-0.09 g/dL Standard Deviation 0.396	0.00 g/dL Standard Deviation 0.515

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=10 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=10 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=40 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Prothrombin Intl. Normalised Ratio	0.03 Prothombin intl. normalised ratio Standard Deviation 0.210	0.01 Prothombin intl. normalised ratio Standard Deviation 0.160	0.10 Prothombin intl. normalised ratio Standard Deviation 0.141	0.01 Prothombin intl. normalised ratio Standard Deviation 0.088	0.08 Prothombin intl. normalised ratio Standard Deviation 0.387

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=10 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=10 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=40 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Prothrombin Time	0.48 second Standard Deviation 1.566	0.07 second Standard Deviation 1.561	0.69 second Standard Deviation 1.268	0.33 second Standard Deviation 0.736	0.78 second Standard Deviation 3.445

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Sodium	0.0 mmol/L Standard Deviation 2.22	1.8 mmol/L Standard Deviation 3.89	0.9 mmol/L Standard Deviation 3.59	2.5 mmol/L Standard Deviation 5.05	1.0 mmol/L Standard Deviation 3.46

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Triglycerides	16.6 mg/dL Standard Deviation 123.84	5.7 mg/dL Standard Deviation 51.48	-16.5 mg/dL Standard Deviation 25.80	-23.2 mg/dL Standard Deviation 123.79	-2.6 mg/dL Standard Deviation 80.08

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Urate	0.51 mg/dL Standard Deviation 0.485	0.04 mg/dL Standard Deviation 1.107	-0.28 mg/dL Standard Deviation 0.877	-0.08 mg/dL Standard Deviation 0.926	-0.05 mg/dL Standard Deviation 1.040

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=41 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Plasma Urea Nitrogen	2.8 mg/dL Standard Deviation 3.65	-2.6 mg/dL Standard Deviation 4.18	3.6 mg/dL Standard Deviation 5.95	1.1 mg/dL Standard Deviation 11.42	2.3 mg/dL Standard Deviation 6.15

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Basophils	0.02 cells x 10^9/L Standard Deviation 0.058	0.03 cells x 10^9/L Standard Deviation 0.047	0.02 cells x 10^9/L Standard Deviation 0.60	-0.03 cells x 10^9/L Standard Deviation 0.048	0.02 cells x 10^9/L Standard Deviation 0.063

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Basophils/Leukocytes	0.08 percentage of basophils in leukocytes Standard Deviation 0.389	-0.01 percentage of basophils in leukocytes Standard Deviation 0.459	0.18 percentage of basophils in leukocytes Standard Deviation 0.547	-0.13 percentage of basophils in leukocytes Standard Deviation 0.419	0.16 percentage of basophils in leukocytes Standard Deviation 0.433

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=12 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Eosinophils	0.01 cells x 10^9/L Standard Deviation 0.108	0.01 cells x 10^9/L Standard Deviation 0.122	0.00 cells x 10^9/L Standard Deviation 0.184	0.01 cells x 10^9/L Standard Deviation 0.099	0.03 cells x 10^9/L Standard Deviation 0.162

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Eosinophils/Leukocytes	0.32 percentage of Eosinophils in Leukocytes Standard Deviation 1.375	0.09 percentage of Eosinophils in Leukocytes Standard Deviation 0.984	-0.02 percentage of Eosinophils in Leukocytes Standard Deviation 2.245	0.33 percentage of Eosinophils in Leukocytes Standard Deviation 1.430	0.27 percentage of Eosinophils in Leukocytes Standard Deviation 1.922

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

HGB - Hemoglobin

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration	-0.20 g/dL Standard Deviation 0.603	-0.18 g/dL Standard Deviation 0.778	-0.24 g/dL Standard Deviation 0.439	-0.16 g/dL Standard Deviation 0.556	-0.28 g/dL Standard Deviation 0.891

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin	-0.2 picogram(s) Standard Deviation 0.58	-0.3 picogram(s) Standard Deviation 0.47	-0.5 picogram(s) Standard Deviation 0.82	0.0 picogram(s) Standard Deviation 0.82	-0.1 picogram(s) Standard Deviation 0.80

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Erythrocyte Mean Corpuscular Volume	-0.21 fL Standard Deviation 1.472	-0.02 fL Standard Deviation 2.093	-0.33 fL Standard Deviation 1.251	0.03 fL Standard Deviation 1.931	0.44 fL Standard Deviation 1.801

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Erythrocytes	-0.004 cells x 10^12/L Standard Deviation 0.2946	0.055 cells x 10^12/L Standard Deviation 0.2211	0.010 cells x 10^12/L Standard Deviation 0.2326	-0.55 cells x 10^12/L Standard Deviation 0.1761	-0.003 cells x 10^12/L Standard Deviation 0.2968

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Hematocrit	-0.3 percentage of red blood cells in blood Standard Deviation 2.34	0.5 percentage of red blood cells in blood Standard Deviation 2.11	-0.1 percentage of red blood cells in blood Standard Deviation 2.26	-0.8 percentage of red blood cells in blood Standard Deviation 1.55	0.2 percentage of red blood cells in blood Standard Deviation 2.61

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Hemoglobin	-0.12 g/dL Standard Deviation 0.802	0.13 g/dL Standard Deviation 0.588	-0.10 g/dL Standard Deviation 0.784	-0.25 g/dL Standard Deviation 0.488	-0.07 g/dL Standard Deviation 0.923

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Leukocytes	-0.98 cells x 10^3/microlitre Standard Deviation 1.915	0.45 cells x 10^3/microlitre Standard Deviation 1.012	0.37 cells x 10^3/microlitre Standard Deviation 1.819	-0.09 cells x 10^3/microlitre Standard Deviation 1.928	-0.09 cells x 10^3/microlitre Standard Deviation 1.711

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Lymphocytes	-0.080 cells x 10^3/L Standard Deviation 0.2152	0.122 cells x 10^3/L Standard Deviation 0.3541	0.099 cells x 10^3/L Standard Deviation 0.4865	0.194 cells x 10^3/L Standard Deviation 0.9257	0.161 cells x 10^3/L Standard Deviation 0.4165

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Lymphocytes/Leukocytes	2.51 percentage of lymphocytes in leukocytes Standard Deviation 5.052	0.06 percentage of lymphocytes in leukocytes Standard Deviation 6.287	-0.99 percentage of lymphocytes in leukocytes Standard Deviation 8.132	1.52 percentage of lymphocytes in leukocytes Standard Deviation 7.013	2.61 percentage of lymphocytes in leukocytes Standard Deviation 7.099

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Monocytes/Leukocytes	1.38 percentage of monocytes in leukocytes Standard Deviation 1.641	0.25 percentage of monocytes in leukocytes Standard Deviation 2.056	0.99 percentage of monocytes in leukocytes Standard Deviation 3.022	0.56 percentage of monocytes in leukocytes Standard Deviation 1.532	-0.21 percentage of monocytes in leukocytes Standard Deviation 2.262

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Neutrophils	-0.954 cells x 10^3/L Standard Deviation 1.6290	0.255 cells x 10^3/L Standard Deviation 1.1041	0.137 cells x 10^3/L Standard Deviation 1.6023	-0.289 cells x 10^3/L Standard Deviation 1.4171	-0.281 cells x 10^3/L Standard Deviation 1.5104

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Neutrophils/Leukocytes	-4.28 percentage of neutrophils in leukocytes Standard Deviation 5.941	-0.39 percentage of neutrophils in leukocytes Standard Deviation 6.548	-0.16 percentage of neutrophils in leukocytes Standard Deviation 8.247	-2.28 percentage of neutrophils in leukocytes Standard Deviation 7.230	-2.84 percentage of neutrophils in leukocytes Standard Deviation 7.830

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=10 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=43 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Platelets	5.2 cells x 10^9/L Standard Deviation 31.68	26.2 cells x 10^9/L Standard Deviation 30.10	4.8 cells x 10^9/L Standard Deviation 28.72	0.9 cells x 10^9/L Standard Deviation 27.65	19.1 cells x 10^9/L Standard Deviation 54.30

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=10 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=39 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Reticulocytes/Erythrocytes	-0.08 percentage of reticulocytes/erythrocytes Standard Deviation 0.626	-0.11 percentage of reticulocytes/erythrocytes Standard Deviation 0.554	-0.30 percentage of reticulocytes/erythrocytes Standard Deviation 0.615	-0.12 percentage of reticulocytes/erythrocytes Standard Deviation 0.290	-0.14 percentage of reticulocytes/erythrocytes Standard Deviation 0.536

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=42 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Urine Albumin	1.117 mg/dL Standard Deviation 118.7664	-19.044 mg/dL Standard Deviation 119.7149	-8.455 mg/dL Standard Deviation 53.9332	-35.964 mg/dL Standard Deviation 178.9164	-28.433 mg/dL Standard Deviation 107.8847

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=42 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Urine Creatinine	10.65 mg/dL Standard Deviation 35.931	-11.67 mg/dL Standard Deviation 33.432	-15.37 mg/dL Standard Deviation 30.920	25.30 mg/dL Standard Deviation 84.654	-6.96 mg/dL Standard Deviation 31.530

PRIMARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=42 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Urine Protein	-19.3 mg/dL Standard Deviation 139.96	-8.9 mg/dL Standard Deviation 134.17	-9.0 mg/dL Standard Deviation 80.51	-80.6 mg/dL Standard Deviation 230.57	-35.1 mg/dL Standard Deviation 144.93

SECONDARY outcome

Timeframe: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 12 and Baseline to Week 24

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=43 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Cystatin C equation Week 12	-4.9 mL/min/1.73 m^2 Standard Deviation 11.74	-3.1 mL/min/1.73 m^2 Standard Deviation 3.91	-1.6 mL/min/1.73 m^2 Standard Deviation 8.61	0.2 mL/min/1.73 m^2 Standard Deviation 9.51	-1.7 mL/min/1.73 m^2 Standard Deviation 9.49
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Cystatin C equation Week 24	-0.8 mL/min/1.73 m^2 Standard Deviation 6.63	-3.2 mL/min/1.73 m^2 Standard Deviation 10.40	-1.3 mL/min/1.73 m^2 Standard Deviation 9.69	-3.2 mL/min/1.73 m^2 Standard Deviation 9.60	-2.0 mL/min/1.73 m^2 Standard Deviation 8.86
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Creatinine equation Week 12	-3.0 mL/min/1.73 m^2 Standard Deviation 6.47	-4.2 mL/min/1.73 m^2 Standard Deviation 11.50	-3.9 mL/min/1.73 m^2 Standard Deviation 5.74	-4.8 mL/min/1.73 m^2 Standard Deviation 9.68	-4.7 mL/min/1.73 m^2 Standard Deviation 9.68
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Creatinine equation Week 24	-3.1 mL/min/1.73 m^2 Standard Deviation 5.74	-8.2 mL/min/1.73 m^2 Standard Deviation 9.89	-5.3 mL/min/1.73 m^2 Standard Deviation 10.59	-2.0 mL/min/1.73 m^2 Standard Deviation 8.29	-4.7 mL/min/1.73 m^2 Standard Deviation 8.80
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Creatinine-Cystatin C equation Week 12	-5.3 mL/min/1.73 m^2 Standard Deviation 8.92	-3.5 mL/min/1.73 m^2 Standard Deviation 5.61	-2.6 mL/min/1.73 m^2 Standard Deviation 6.53	-2.8 mL/min/1.73 m^2 Standard Deviation 8.57	-3.2 mL/min/1.73 m^2 Standard Deviation 8.43
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 MDRD Creatinine equation Week 12	-4.7 mL/min/1.73 m^2 Standard Deviation 10.82	-5.1 mL/min/1.73 m^2 Standard Deviation 13.75	-4.6 mL/min/1.73 m^2 Standard Deviation 6.23	-6.7 mL/min/1.73 m^2 Standard Deviation 14.03	-5.6 mL/min/1.73 m^2 Standard Deviation 13.76
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 CKD-EPI Creatinine-Cystatin C equation Week 24	-2.4 mL/min/1.73 m^2 Standard Deviation 5.24	-5.5 mL/min/1.73 m^2 Standard Deviation 9.20	-3.2 mL/min/1.73 m^2 Standard Deviation 9.18	-2.8 mL/min/1.73 m^2 Standard Deviation 7.93	-3.4 mL/min/1.73 m^2 Standard Deviation 7.82
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24 MDRD Creatinine equation Week 24	-4.5 mL/min/1.73 m^2 Standard Deviation 11.12	-8.8 mL/min/1.73 m^2 Standard Deviation 12.85	-5.9 mL/min/1.73 m^2 Standard Deviation 10.05	-4.0 mL/min/1.73 m^2 Standard Deviation 10.77	-5.8 mL/min/1.73 m^2 Standard Deviation 10.95

SECONDARY outcome

Timeframe: Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension

1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24

Outcome measures

Measure	Placebo n=12 Participants Placebo control	CCX140-B 5 mg Once Daily n=11 Participants CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg Twice Daily n=11 Participants CCX140-B 10 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg Twice Daily n=11 Participants CCX140-B 15 mg twice daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Open-label Extension n=43 Participants Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24 Complete renal remission	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24 Partial remission (definition 1)	1 Participants	0 Participants	0 Participants	1 Participants	4 Participants
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24 Partial remission (definition 2)	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

CCX140-B 5 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

CCX140-B 10 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CCX140-B 15 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Open Label

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

CCX140-B 5mg Open Label

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

CCX140-B 10mg Open Label

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

CCX140-B 15mg Open Label

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=11 participants at risk Placebo control	CCX140-B 5 mg n=11 participants at risk CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg n=12 participants at risk CCX140-B 10 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg n=11 participants at risk CCX140-B 15 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Placebo Open Label n=11 participants at risk Placebo control For Period B of trial	CCX140-B 5mg Open Label n=11 participants at risk CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial	CCX140-B 10mg Open Label n=11 participants at risk CCX140-B 10 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial	CCX140-B 15mg Open Label n=10 participants at risk CCX140-B 15 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Dermo-hypodermitis	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24

Other adverse events

Measure	Placebo n=11 participants at risk Placebo control	CCX140-B 5 mg n=11 participants at risk CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 10 mg n=12 participants at risk CCX140-B 10 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	CCX140-B 15 mg n=11 participants at risk CCX140-B 15 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2	Placebo Open Label n=11 participants at risk Placebo control For Period B of trial	CCX140-B 5mg Open Label n=11 participants at risk CCX140-B 5 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial	CCX140-B 10mg Open Label n=11 participants at risk CCX140-B 10 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial	CCX140-B 15mg Open Label n=10 participants at risk CCX140-B 15 mg once daily CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial
Infections and infestations Nasopharyngitis	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Bronchitis	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Conjunctivitis	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Dermo-hypodermitis	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Herpes dermatitis	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Hordeolum	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Influenza	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Pharyngitis streptococcal	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Infections and infestations Sinusitis	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Infections and infestations Viral upper respiratory tract infection	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
General disorders Oedema peripheral	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	36.4% 4/11 • Number of events 5 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	27.3% 3/11 • Number of events 3 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
General disorders Fatigue	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 3 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
General disorders Oedema	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
General disorders Asthenia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
General disorders Chest pain	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
General disorders Chills	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
General disorders Influenza like illness	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
General disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Muscle spasms	18.2% 2/11 • Number of events 4 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	18.2% 2/11 • Number of events 3 • From Baseline to Week 24	18.2% 2/11 • Number of events 4 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 2 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Metabolism and nutrition disorders Gout	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	16.7% 2/12 • Number of events 2 • From Baseline to Week 24	18.2% 2/11 • Number of events 5 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	20.0% 2/10 • Number of events 3 • From Baseline to Week 24
Metabolism and nutrition disorders Folate deficiency	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Gastrointestinal disorders Nausea	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Vomiting	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Abdominal tenderness	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Constipation	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Dental caries	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Flatulence	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Gastrointestinal pain	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Infrequent bowel movements	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Gastrointestinal disorders Lip swelling	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Headache	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	8.3% 1/12 • Number of events 6 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Nervous system disorders Dizziness	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	8.3% 1/12 • Number of events 2 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Carpal tunnel syndrome	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Dizziness postural	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Hypoaesthesia	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Migraine	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Paraesthesia	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Presyncope	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Nervous system disorders Sciatica	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Blood creatinine increased	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Blood creatine phosphokinase increased	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Blood potassium increased	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 2 • From Baseline to Week 24
Investigations C-reactive protein increased	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Grip strength decreased	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Immunosuppressant drug level increased	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Lipase increased	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Weight increased	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • From Baseline to Week 24	18.2% 2/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Respiratory, thoracic and mediastinal disorders Productive cough	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	8.3% 1/12 • Number of events 3 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Blister	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Photosensitivity reaction	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Injury, poisoning and procedural complications Animal bite	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Injury, poisoning and procedural complications Contusion	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Injury, poisoning and procedural complications Fall	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Investigations Cystatin C increased	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Reproductive system and breast disorders Menorrhagia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Reproductive system and breast disorders Menstruation delayed	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Reproductive system and breast disorders Metrorrhagia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Reproductive system and breast disorders Nipple pain	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Vascular disorders Hypertension	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Vascular disorders Hot flush	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Vascular disorders Orthostatic hypotension	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Renal and urinary disorders Proteinuria	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Renal and urinary disorders Renal impairment	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 2 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Psychiatric disorders Insomnia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Psychiatric disorders Psychotic disorder	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Cardiac disorders Tachycardia	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	10.0% 1/10 • Number of events 1 • From Baseline to Week 24
Endocrine disorders Hypothyroidism	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	8.3% 1/12 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Eye disorders Blepharospasm	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Hepatobiliary disorders Gallbladder polyp	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Immune system disorders Hypersensitivity	0.00% 0/11 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/12 • From Baseline to Week 24	9.1% 1/11 • Number of events 1 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/11 • From Baseline to Week 24	0.00% 0/10 • From Baseline to Week 24

Additional Information

Study Director

ChemoCentryx

Phone: 650-210-2900

Email: clinicaltrials@chemocentryx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER