At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment
In Brief
A Phase 2 clinical trial evaluating Placebo and CCX168 for Vasculitis. Completed, enrolled 67 participants across 44 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasculitis
CountriesAustria, Belgium, Czechia, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartSep 2011
Primary CompletionOct 2015
Study CompletionJan 2016
TodayJul 2026
First PostedJun 1, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.1 years ago
Interventions
Placebodrug
BID for 84 days
CCX168drug
BID for 84 days