Phase 2 N=67 Randomized Triple-blind Treatment

A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

Vasculitis

Bottom Line

View on ClinicalTrials.gov: NCT01363388 ↗

Enrolled (actual)

Serious AEs

34.3%

Results posted

Jul 2020

Primary outcome: Primary: Proportion of Subjects Achieving Disease Response at Day 85 — 0.7; 0.86; 0.81 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); CCX168 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Achieving Disease Response at Day 85	0.7; 0.86; 0.81	—
SECONDARY Proportion of Patients Achieving Renal Response at Day 85	0.4; 0.56; 0.33	—
SECONDARY Proportion of Subjects Achieving Disease Remission at Day 85	0.35; 0.27; 0.19	—
SECONDARY Percent Change From Baseline to Day 85 in BVAS	-56.45; -79.05; -73.01	—
SECONDARY Change From Baseline to Day 85 in eGFR	5.55; 6.00; 0.79	—
SECONDARY Percent Change From Baseline to Day 85 in eGFR	15.36; 19.91; 0.92	—
SECONDARY Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf at Any Time During the 84-day Treatment Period	0.79; 0.61; 0.61	—
SECONDARY Time to First Achieving Urinary RBC Count <=5/Hpf at Any Point During the 84-day Treatment Period	69.0; 69.0; 42.0	—
SECONDARY Proportion of Subjects Achieving Urinary RBC Count <30/Hpf at Any Time During the 84-day Treatment Period	11; 13; 5	—
SECONDARY Time to First Achieving Urinary RBC Count <=30/Hpf at Any Point During the 84-day Treatment Period	10.5; 21.0; 42.0	—
SECONDARY Percent Change From Baseline to Day 85 in Urinary RBC Count	-72.37; 1.63; -21.26	—
SECONDARY Percent Change From Baseline to Day 85 in UACR	-3.10; -34.18; -15.21	—
SECONDARY Percent Change From Baseline to Day 85 in Urinary MCP-1:Creatinine Ratio	-37.57; -59.29; -39.44	—
SECONDARY Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment	0; 0.33; 0.13	—
SECONDARY Change From Baseline to Day 85 in the Vasculitis Damage Index	0.7; 0.3; 0.2	—
SECONDARY Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the SF-36 v2	9.7; 13.8; 8.6; 13.7; 36.1; 16.1	—
SECONDARY Change From Baseline to Day 85 in Health-related Quality of Life as Measured by the EQ-5D-5L	-2.4; 6.5; 4.5; -3.3; 11.8; 4.0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01363388). 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.