Vasculitis
Conditions
Brief summary
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.
Detailed description
The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment. The primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS) version 3. The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Interventions
DRUGPlacebo
BID for 84 days
DRUGCCX168
BID for 84 days
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis * Male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required * Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening * Estimated glomerular filtration rate (eGFR) ≥ 20mL/min * Have at least one major item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3 Key
Exclusion criteria
* Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement * Any other multi-system autoimmune disease * Medical history of coagulopathy or bleeding disorder * Received cyclophosphamide within 12 weeks of screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1 * Received high-dose intravenous corticosteroids within 4 weeks of screening * On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening * Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-TNF treatment, abatacept, alemtuzumab, IVIg or plasma exchange within 12 weeks of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Disease Response at Day 85 | Baseline to Day 85 | Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period | Baseline to Day 85 | In subjects with baseline hematuria \>5 RBCs/hpf (Red Blood Cell/High Power Field) |
| Proportion of Patients Achieving Renal Response at Day 85 | Baseline to Day 85 | Renal response, assessed in patients with hematuria and albuminuria at baseline, and defined as an improvement in renal parameters, i.e., an increase from baseline to Day 85 in eGFR (Estimated glomerular filtration rate), MDRD (Modification of Diet in Renal Disease), serum creatinine equation, a decrease from baseline to Day 85 in haematuria (central laboratory microscopic count of urinary red blood cells) , decrease from baseline to Day 85 in albuminuria count (first morning UACR (urinary albumin:creatinine ratio). |
| Proportion of Subjects Achieving Disease Remission at Day 85 | Day 85 | Disease remission is defined as BVAS (Birmingham Vasculitis Activity Score) of 0 or 1 plus no worsening in eGFR (Estimated glomerular filtration rate) and urinary RBC (Red Blood cell) count \<10/high power field (hpf) |
| Percent Change From Baseline to Day 85 in BVAS | Baseline to Day 85 | Percent change in Burmingham Vasculitis Index Score (BVAS) at week 12, higher percentage change indicates worse outcome BVAS = Birmingham Vasculitis Activity Score The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health. |
| Change From Baseline to Day 85 in eGFR | Baseline to Day 85 | eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine |
| Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period | Baseline to Day 85 | In subjects with baseline hematuria \<=5 RBCs/hpf (Red Blood Cell/High Power Field) |
| Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period | Baseline to Day 85 | In subjects with baseline hematuria \>=30 RBCs/hpf,(Red Blood Cell/High Power Field) |
| Percent Change From Baseline to Day 85 in eGFR | Baseline to Day 85 | eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine |
| Percent Change From Baseline to Day 85 in Urinary RBC Count | Baseline to day 85 | In subjects with hematuria at baseline, RBC (Red Blood Cell) |
| Percent Change From Baseline to Day 85 in UACR | Baseline to Day 85 | In subjects with albuminuria at baseline UACR (urinary albumin:creatinine ratio) |
| Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio | Baseline to Day 85 | Urinary Monocyte Chemoattractant Protein-1 (MCP-1):creatinine ratio |
| Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment | Baseline to Day 85 | — |
| Change From Baseline to Day 85 in the Vasculitis Damage Index | Baseline to Day 85 | VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). |
| Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | Baseline, Day 29 & Day 85 | SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health). |
| Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Baseline, Day 29 and Day 85 | EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health). |
| Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period | Baseline to Day 85 | In subjects with baseline hematuria \<=30 RBCs/hpf (Red Blood Cell/High Power Field) |
Countries
Austria, Belgium, Czechia, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo BID Plus 60 mg Prednisone Drug: Placebo BID plus 60 mg prednisone | 23 |
| CCX168 30 mg BID Plus 20 mg Prednisone Drug: CCX168 30 mg BID plus 20 mg prednisone | 22 |
| CCX168 30 mg BID Without Prednisone Drug: CCX168 30 mg BID without prednisone | 22 |
| Total | 67 |
Baseline characteristics
| Characteristic | CCX168 30 mg BID Plus 20 mg Prednisone | Placebo BID Plus 60 mg Prednisone | Total | CCX168 30 mg BID Without Prednisone |
|---|---|---|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 14.2 | 59.1 years STANDARD_DEVIATION 14 | 57.9 years STANDARD_DEVIATION 13.9 | 57.4 years STANDARD_DEVIATION 14 |
| Albumin: creatinine ratio | 278.6 mg/g | 353.9 mg/g | 303.8 mg/g | 283.4 mg/g |
| ANCA- associated vasculitis disease duration at screening | 0.0 months | 0.0 months | 0.0 months | 1.0 months |
| ANCA disease status Newly diagnosed | 15 Participants | 18 Participants | 49 Participants | 16 Participants |
| ANCA disease status Relapsed | 7 Participants | 5 Participants | 18 Participants | 6 Participants |
| ANCA status categorical ANCA equivocal | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| ANCA status categorical ANCA negative | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| ANCA status categorical Anti-MPO positive | 12 Participants | 10 Participants | 35 Participants | 13 Participants |
| ANCA status categorical Anti-PR3 positive | 10 Participants | 11 Participants | 29 Participants | 8 Participants |
| ANCA status categorical Both anti-MPO positive and anti-PR3 positive | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Background treatment Cyclophosphamide | 17 Participants | 20 Participants | 54 Participants | 17 Participants |
| Background treatment Rituximab | 5 Participants | 3 Participants | 13 Participants | 5 Participants |
| BMI | 24.9 kg/m^2 STANDARD_DEVIATION 4.05 | 27.3 kg/m^2 STANDARD_DEVIATION 7.09 | 26.3 kg/m^2 STANDARD_DEVIATION 5.49 | 26.5 kg/m^2 STANDARD_DEVIATION 4.66 |
| BVAS total score | 14.3 units on a scale STANDARD_DEVIATION 5.98 | 13.2 units on a scale STANDARD_DEVIATION 5.8 | 13.7 units on a scale STANDARD_DEVIATION 5.98 | 13.8 units on a scale STANDARD_DEVIATION 6.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 23 Participants | 67 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Glomerular filtration rate (MDRD) | 52.5 mL/min/1.73 m2 STANDARD_DEVIATION 26.7 | 47.6 mL/min/1.73 m2 STANDARD_DEVIATION 15.08 | 51.6 mL/min/1.73 m2 STANDARD_DEVIATION 20.92 | 54.7 mL/min/1.73 m2 STANDARD_DEVIATION 19.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 23 Participants | 67 Participants | 22 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 47 Participants | 16 Participants |
| Smoking Status Current Smoker | 2 Participants | 3 Participants | 9 Participants | 4 Participants |
| Smoking Status Never Smoked | 14 Participants | 9 Participants | 33 Participants | 10 Participants |
| Smoking Status Past Smoker | 6 Participants | 11 Participants | 25 Participants | 8 Participants |
| Type of AAV GPA | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Type of AAV Microscopic polyangiitis | 9 Participants | 10 Participants | 28 Participants | 9 Participants |
| Type of AAV Renal-limited vasculitis | 2 Participants | 2 Participants | 5 Participants | 1 Participants |
| Type of AAV Unknown | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Urinary MCP-1 : creatinine ratio | 1266.1 pg/mg creatinine | 825.9 pg/mg creatinine | 957.9 pg/mg creatinine | 846.4 pg/mg creatinine |
| Urinary red blood cells 30-49 per hpf | 4 Participants | 6 Participants | 12 Participants | 2 Participants |
| Urinary red blood cells 50-75 per hpf | 4 Participants | 5 Participants | 12 Participants | 3 Participants |
| Urinary red blood cells >75 per hpf | 5 Participants | 3 Participants | 11 Participants | 3 Participants |
| VDI score | 0.9 units on a scale STANDARD_DEVIATION 1.46 | 1.2 units on a scale STANDARD_DEVIATION 1.35 | 0.9 units on a scale STANDARD_DEVIATION 1.35 | 0.5 units on a scale STANDARD_DEVIATION 1.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 21 / 23 | 21 / 22 | 21 / 22 |
| serious Total, serious adverse events | 5 / 23 | 8 / 22 | 10 / 22 |
Outcome results
Primary
Proportion of Subjects Achieving Disease Response at Day 85
Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component.
Time frame: Baseline to Day 85
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Subjects Achieving Disease Response at Day 85 | 0.7 proportion of participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Subjects Achieving Disease Response at Day 85 | 0.86 proportion of participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Subjects Achieving Disease Response at Day 85 | 0.81 proportion of participants |
Secondary
Change From Baseline to Day 85 in eGFR
eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in eGFR | 5.55 ml/min/1.73 m^2 | Standard Deviation 10.211 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in eGFR | 6.00 ml/min/1.73 m^2 | Standard Deviation 10.469 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in eGFR | 0.79 ml/min/1.73 m^2 | Standard Deviation 9.549 |
Secondary
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time frame: Baseline, Day 29 and Day 85
Population: Number of subjects with data at baseline and the specified visit are specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 29) | -2.4 Change from baseline score on a scale | Standard Deviation 10.61 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 85) | -3.3 Change from baseline score on a scale | Standard Deviation 13.23 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 29) | -0.044 Change from baseline score on a scale | Standard Deviation 0.1597 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 85) | -0.043 Change from baseline score on a scale | Standard Deviation 0.1718 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 85) | 0.067 Change from baseline score on a scale | Standard Deviation 0.1314 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 29) | 6.5 Change from baseline score on a scale | Standard Deviation 17.96 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 29) | 0.034 Change from baseline score on a scale | Standard Deviation 0.1111 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 85) | 11.8 Change from baseline score on a scale | Standard Deviation 17.61 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 85) | -0.047 Change from baseline score on a scale | Standard Deviation 0.0721 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 85) | 4.0 Change from baseline score on a scale | Standard Deviation 4.69 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | Index Score (Day 29) | -0.057 Change from baseline score on a scale | Standard Deviation 0.0952 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L | VAS Score (Day 29) | 4.5 Change from baseline score on a scale | Standard Deviation 12.62 |
Secondary
Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2
SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Time frame: Baseline, Day 29 & Day 85
Population: Number of subjects with data at baseline and the specified visit are specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 85) | 4.36 Change from baseline score on a scale | Standard Error 6.457 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 85) | -0.766 Change from baseline score on a scale | Standard Error 3.888 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 29) | 5.0 Change from baseline score on a scale | Standard Error 6.18 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 29) | -2.8 Change from baseline score on a scale | Standard Error 11.74 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 85) | 5.383 Change from baseline score on a scale | Standard Error 2.694 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 85) | 0.0 Change from baseline score on a scale | Standard Error 0.37 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 85) | 6.3 Change from baseline score on a scale | Standard Error 9.9 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 85) | 12.8 Change from baseline score on a scale | Standard Error 7.36 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 29) | 0.2 Change from baseline score on a scale | Standard Error 0.22 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 29) | 1.7 Change from baseline score on a scale | Standard Error 2.2 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 85) | 13.7 Change from baseline score on a scale | Standard Error 11.06 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 85) | -1.0 Change from baseline score on a scale | Standard Error 4.88 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 29) | 2.693 Change from baseline score on a scale | Standard Error 3.436 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 29) | 2.5 Change from baseline score on a scale | Standard Error 8.26 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 29) | 9.7 Change from baseline score on a scale | Standard Error 10.73 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 85) | 0.0 Change from baseline score on a scale | Standard Error 10.98 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 85) | 5.7 Change from baseline score on a scale | Standard Error 6.05 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 29) | 0.303 Change from baseline score on a scale | Standard Error 3.12 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 29) | 1.9 Change from baseline score on a scale | Standard Error 9.08 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 29) | 7.63 Change from baseline score on a scale | Standard Error 6.403 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 29) | 3.1 Change from baseline score on a scale | Standard Error 10.63 |
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 85) | 5.2 Change from baseline score on a scale | Standard Error 7 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 85) | 11.779 Change from baseline score on a scale | Standard Error 3.428 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 29) | 13.8 Change from baseline score on a scale | Standard Error 7.61 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 85) | 36.1 Change from baseline score on a scale | Standard Error 9.28 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 29) | 17.3 Change from baseline score on a scale | Standard Error 8.42 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 85) | 21.7 Change from baseline score on a scale | Standard Error 9.54 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 29) | 3.7 Change from baseline score on a scale | Standard Error 4.6 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 85) | 2.3 Change from baseline score on a scale | Standard Error 3.93 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 29) | 12.98 Change from baseline score on a scale | Standard Error 7.4 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 85) | 22.28 Change from baseline score on a scale | Standard Error 7.541 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 29) | 24.1 Change from baseline score on a scale | Standard Error 6.07 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 85) | 35.6 Change from baseline score on a scale | Standard Error 6.91 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 29) | 10.8 Change from baseline score on a scale | Standard Error 3.71 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 85) | 16.5 Change from baseline score on a scale | Standard Error 4.65 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 29) | -0.6 Change from baseline score on a scale | Standard Error 0.41 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 85) | -1.2 Change from baseline score on a scale | Standard Error 0.48 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 29) | 7.0 Change from baseline score on a scale | Standard Error 6.9 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 85) | 13.5 Change from baseline score on a scale | Standard Error 7.73 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 29) | 20.3 Change from baseline score on a scale | Standard Error 8.04 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 85) | 21.8 Change from baseline score on a scale | Standard Error 9.42 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 29) | 4.074 Change from baseline score on a scale | Standard Error 2.601 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 85) | 6.744 Change from baseline score on a scale | Standard Error 3.132 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 29) | 10.855 Change from baseline score on a scale | Standard Error 3.244 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 29) | 8.6 Change from baseline score on a scale | Standard Error 6.02 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 29) | 8.2 Change from baseline score on a scale | Standard Error 11.46 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 29) | -0.78 Change from baseline score on a scale | Standard Error 3.63 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 85) | 4.863 Change from baseline score on a scale | Standard Error 2.415 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Functioning (Day 85) | 11.4 Change from baseline score on a scale | Standard Error 8.43 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 85) | -1.5 Change from baseline score on a scale | Standard Error 5.51 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role Physical (Day 85) | 16.1 Change from baseline score on a scale | Standard Error 9.24 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 29) | -1.1 Change from baseline score on a scale | Standard Error 8.97 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 General Health Perceptions (Day 29) | -13.7 Change from baseline score on a scale | Standard Error 10.21 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 85) | 2.197 Change from baseline score on a scale | Standard Error 1.066 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Role-Emotional (Day 85) | 10.7 Change from baseline score on a scale | Standard Error 8.27 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 85) | 14.0 Change from baseline score on a scale | Standard Error 9.3 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 29) | -8.1 Change from baseline score on a scale | Standard Error 6.88 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health Summary (Day 29) | -4.760 Change from baseline score on a scale | Standard Error 3.266 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Mental Health (Day 85) | 2.1 Change from baseline score on a scale | Standard Error 4.86 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 85) | 5.4 Change from baseline score on a scale | Standard Error 3.72 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Physical Component Summary (Day 29) | 2.826 Change from baseline score on a scale | Standard Error 4.526 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 29) | 0.3 Change from baseline score on a scale | Standard Error 0.31 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Social Functioning (Day 29) | -7.8 Change from baseline score on a scale | Standard Error 6.22 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Bodily pain (Day 29) | 5.1 Change from baseline score on a scale | Standard Error 16.75 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Reported Health Transition (Day 85) | -0.4 Change from baseline score on a scale | Standard Error 0.48 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2 | SF-36 Vitality (Day 85) | 10.71 Change from baseline score on a scale | Standard Error 5.893 |
Secondary
Change From Baseline to Day 85 in the Vasculitis Damage Index
VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Change From Baseline to Day 85 in the Vasculitis Damage Index | 0.7 score on a scale | Standard Deviation 0.81 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Change From Baseline to Day 85 in the Vasculitis Damage Index | 0.3 score on a scale | Standard Deviation 0.57 |
| CCX168 30 mg BID Without Prednisone | Change From Baseline to Day 85 in the Vasculitis Damage Index | 0.2 score on a scale | Standard Deviation 0.54 |
Secondary
Percent Change From Baseline to Day 85 in BVAS
Percent change in Burmingham Vasculitis Index Score (BVAS) at week 12, higher percentage change indicates worse outcome BVAS = Birmingham Vasculitis Activity Score The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Percent Change From Baseline to Day 85 in BVAS | -56.45 percentage change | Standard Deviation 62.1 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Percent Change From Baseline to Day 85 in BVAS | -79.05 percentage change | Standard Deviation 23.005 |
| CCX168 30 mg BID Without Prednisone | Percent Change From Baseline to Day 85 in BVAS | -73.01 percentage change | Standard Deviation 29.464 |
Secondary
Percent Change From Baseline to Day 85 in eGFR
eGFR (Estimated glomerular filtration rate) based on the MDRD (Modification of Diet in Renal Disease) formula using serum creatinine
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Percent Change From Baseline to Day 85 in eGFR | 15.36 percentage change | Standard Deviation 23.685 |
| CCX168 30 mg BID Plus 20 mg Prednisone | Percent Change From Baseline to Day 85 in eGFR | 19.91 percentage change | Standard Deviation 23.034 |
| CCX168 30 mg BID Without Prednisone | Percent Change From Baseline to Day 85 in eGFR | 0.92 percentage change | Standard Deviation 20.562 |
Secondary
Percent Change From Baseline to Day 85 in UACR
In subjects with albuminuria at baseline UACR (urinary albumin:creatinine ratio)
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Percent Change From Baseline to Day 85 in UACR | -3.10 percentage change |
| CCX168 30 mg BID Plus 20 mg Prednisone | Percent Change From Baseline to Day 85 in UACR | -34.18 percentage change |
| CCX168 30 mg BID Without Prednisone | Percent Change From Baseline to Day 85 in UACR | -15.21 percentage change |
Secondary
Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio
Urinary Monocyte Chemoattractant Protein-1 (MCP-1):creatinine ratio
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio | -37.57 percentage change |
| CCX168 30 mg BID Plus 20 mg Prednisone | Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio | -59.29 percentage change |
| CCX168 30 mg BID Without Prednisone | Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio | -39.44 percentage change |
Secondary
Percent Change From Baseline to Day 85 in Urinary RBC Count
In subjects with hematuria at baseline, RBC (Red Blood Cell)
Time frame: Baseline to day 85
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Percent Change From Baseline to Day 85 in Urinary RBC Count | -72.37 percentage change |
| CCX168 30 mg BID Plus 20 mg Prednisone | Percent Change From Baseline to Day 85 in Urinary RBC Count | 1.63 percentage change |
| CCX168 30 mg BID Without Prednisone | Percent Change From Baseline to Day 85 in Urinary RBC Count | -21.26 percentage change |
Secondary
Proportion of Patients Achieving Renal Response at Day 85
Renal response, assessed in patients with hematuria and albuminuria at baseline, and defined as an improvement in renal parameters, i.e., an increase from baseline to Day 85 in eGFR (Estimated glomerular filtration rate), MDRD (Modification of Diet in Renal Disease), serum creatinine equation, a decrease from baseline to Day 85 in haematuria (central laboratory microscopic count of urinary red blood cells) , decrease from baseline to Day 85 in albuminuria count (first morning UACR (urinary albumin:creatinine ratio).
Time frame: Baseline to Day 85
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Patients Achieving Renal Response at Day 85 | 0.4 proportion of participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Patients Achieving Renal Response at Day 85 | 0.56 proportion of participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Patients Achieving Renal Response at Day 85 | 0.33 proportion of participants |
Secondary
Proportion of Subjects Achieving Disease Remission at Day 85
Disease remission is defined as BVAS (Birmingham Vasculitis Activity Score) of 0 or 1 plus no worsening in eGFR (Estimated glomerular filtration rate) and urinary RBC (Red Blood cell) count \<10/high power field (hpf)
Time frame: Day 85
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Subjects Achieving Disease Remission at Day 85 | 0.35 proportion of participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Subjects Achieving Disease Remission at Day 85 | 0.27 proportion of participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Subjects Achieving Disease Remission at Day 85 | 0.19 proportion of participants |
Secondary
Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period
In subjects with baseline hematuria \>=30 RBCs/hpf,(Red Blood Cell/High Power Field)
Time frame: Baseline to Day 85
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period | 11 Participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period | 13 Participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period | 5 Participants |
Secondary
Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period
In subjects with baseline hematuria \>5 RBCs/hpf (Red Blood Cell/High Power Field)
Time frame: Baseline to Day 85
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period | 0.79 proportion of participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period | 0.61 proportion of participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period | 0.61 proportion of participants |
Secondary
Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment
Time frame: Baseline to Day 85
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment | 0 proportion of participants |
| CCX168 30 mg BID Plus 20 mg Prednisone | Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment | 0.33 proportion of participants |
| CCX168 30 mg BID Without Prednisone | Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment | 0.13 proportion of participants |
Secondary
Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period
In subjects with baseline hematuria \<=30 RBCs/hpf (Red Blood Cell/High Power Field)
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period | 10.5 days |
| CCX168 30 mg BID Plus 20 mg Prednisone | Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period | 21.0 days |
| CCX168 30 mg BID Without Prednisone | Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period | 42.0 days |
Secondary
Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period
In subjects with baseline hematuria \<=5 RBCs/hpf (Red Blood Cell/High Power Field)
Time frame: Baseline to Day 85
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo BID Plus 60 mg Prednisone | Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period | 69.0 days |
| CCX168 30 mg BID Plus 20 mg Prednisone | Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period | 69.0 days |
| CCX168 30 mg BID Without Prednisone | Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period | 42.0 days |