Phase 2
N=42
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
ANCA-associated Vasculitis
Bottom Line
View on ClinicalTrials.gov: NCT02222155 ↗Enrolled (actual)
42
Serious AEs
21.4%
Results posted
Aug 2023
Primary outcome: Primary: Incidence of Adverse Events — 13; 11; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids (Drug); CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids (Drug); Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
13; 11; 15 | — |
| PRIMARY Proportion of Patients Achieving Disease Response Based on BVAS at Day 85 |
0.85; 0.92; 0.8 | — |
| SECONDARY Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85. |
0.54; 0.67; 0.47 | — |
| SECONDARY Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85. |
0.15; 0.08; 0.2 | — |
| SECONDARY Percent Change From Baseline to Day 85 in BVAS. |
-81.8; -95.6; -81.7 | — |
| SECONDARY Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85 |
0.17; 0.4; 0.63 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate at Day 85 |
2.0; 1.3; 6.2 | — |
| SECONDARY Percentage Change in Estimated Glomerular Filtration Rate at Day 85 |
6.2; 0.9; 7.7 | — |
| SECONDARY Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85 |
-56.3; -31.5; -95.0 | — |
| SECONDARY Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85 |
-66.281; -13.890; -57.596 | — |
| SECONDARY Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85 |
-33.175; -34.802; 63.567 | — |
| SECONDARY Change From Baseline to Day 85 in the VDI |
0.31; 0.09; 0.14 | — |
| SECONDARY Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 |
4.1; 16.1; 9.6; -3.5; 11.0; 14.9 | — |
| SECONDARY Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L |
12.85; 20.18; 11.21; 0.03; 0.05; 0.04 | — |
| SECONDARY Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85 |
0; 0; 0 | — |
Summary
The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Funding Source - FDA OOPD
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
- Male and female subjects, aged at least 18 years, with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required
- Use of adequate contraception during, and for at least the three months after, any administration of study medication is 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
- Have at least one "major" item, or at least 3 other items, or at least 2 renal items on the Birmingham Vasculitis Activity Score (BVAS) version 3
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL per minute
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 prior to 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 intravenous corticosteroids, >3000 mg methylprednisolone equivalent, within 12 weeks prior to screening
- Received an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit
- Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening
Data sourced from ClinicalTrials.gov (NCT02222155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.