Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

Conditions

• ANCA-associated Vasculitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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

Key Dates

Start date

Feb 4, 2015

Status verified

Mar 2025

Primary completion

Apr 24, 2016

Completion

Jul 19, 2016

Study Design

Enrollment

42 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: CCX168 low dose plus standard of care
  Capsule, 10 mg, twice daily + standard of care for 12 weeks
• Active Comparator: CCX168 high dose plus standard of care
  Capsule, 30 mg, twice daily + standard of care for 12 weeks
• Placebo Comparator: Placebo, twice daily + standard of care
  Capsule, placebo, twice daily + standard of care for 12 weeks

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Baseline to Day 85 ]

Locations (39)

Related Studies

• Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
  Recruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland