14 completed, 6 recruiting, 1 active not recruiting, 1 not yet recruiting. 9 Phase 1, 8 Phase 2, 4 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Recruiting 1 |
| Phase 2 | 8 | Completed 5, Recruiting 2, Terminated 1 |
| Phase 3 | 4 | Active not recruiting 1, Completed 1, Not yet recruiting 1, Recruiting 1 |
| Phase 4 | 2 | Recruiting 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube Avacopan - Diffuse Alveolar Hemorrhage, Antineutrophil Cytoplasmic Antibody Positive Vasculitis | Phase 1 | Recruiting | Mayo Clinic | 6 | 2027-08-01 | 2026-10-20 |
| TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis Avacopan, Placebo - Granulomatosis With Polyangiitis, Wegener's | Phase 2 / Phase 3 | Recruiting | Robert Spiera, MD | 30 | 2026-05-22 | 2026-09-02 |
| Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement Avacopan, Placebo - ANCA-Associated Vasculitis (AAV) | Phase 3 | Not yet recruiting | University Hospital, Toulouse | 130 | 2026-03-01 | 2026-01-28 |
| Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN) Avacopan, Prednisone, Methylprednisolone (drug) - IgA Nephropathy (IgAN) | Phase 2 | Recruiting | Mayo Clinic | 16 | 2025-06-09 | 2026-10-09 |
| Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis Avacopan, prednisolone and rituximab, Prednisolone and rituximab - ANCA Associated Vasculitis (AAV) | Phase 4 | Recruiting | Chiba University | 160 | 2024-11-15 | 2025-05-04 |
| Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV. Avacopan - Vasculitis | Phase 3 | Active not recruiting | Amgen | 19 | 2024-10-22 | 2026-07-20 |
| A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) Avacopan - End-Stage Renal Disease (ESRD) | Phase 1 | Completed | Amgen | 13 | 2024-06-18 | 2026-09-11 |
| A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis Avacopan, Placebo, Standard of Care - Antineutrophil Cytoplasmic Antibody-associated Vasculitis | Phase 4 | Recruiting | Amgen | 300 | 2024-02-07 | 2026-09-30 |
| Special Drug Use-results Survey for Long-term Use（Avacopan） Avacopan - Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA) | Recruiting | Kissei Pharmaceutical Co., Ltd. | 250 | 2022-07-29 | 2025-01-17 | |
| Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin Avacopan, Simvastatin - Healthy Volunteers | Phase 1 | Completed | Amgen | 32 | 2022-06-28 | 2024-01-17 |
| A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants Avacopan, Moxifloxacin, Placebo for avacopan - Electrocardiography | Phase 1 | Completed | Amgen | 58 | 2019-11-08 | 2023-08-14 |
| Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA) Avacopan, Placebo - Hidradenitis Suppurativa, Acne Inversa | Phase 2 | Completed | Amgen | 435 | 2018-12-21 | 2025-03-17 |
| A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment Avacopan - Hepatic Impairment | Phase 1 | Completed | Amgen | 24 | 2018-04-17 | 2023-08-22 |
| A Study of CCX168 in Japanese and Caucasian Healthy Adult Males CCX168, Placebo - Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | Phase 1 | Completed | Amgen | 80 | 2017-10-23 | 2023-08-14 |
| Controlled Trial Evaluating Avacopan in C3 Glomerulopathy Avacopan, Avacopan Matching Placebo - C3 Glomerulopathy (C3G) | Phase 2 | Completed | Amgen | 57 | 2017-09-29 | 2025-03-13 |
| A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Avacopan, Prednisone, Cyclophosphamide - ANCA-Associated Vasculitis | Phase 3 | Completed | Amgen | 331 | 2017-03-15 | 2025-03-24 |
| A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications CCX168, Midazolam, Celecoxib - Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | Phase 1 | Completed | Amgen | 32 | 2016-01-14 | 2023-08-22 |
| A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168 CCX168 - Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | Phase 1 | Completed | Amgen | 16 | 2015-12-03 | 2023-08-14 |
| Complement Inhibition in aHUS Dialysis Patients CCX168 - Atypical Hemolytic Uremic Syndrome | Phase 2 | Terminated | Mario Negri Institute for Pharmacological Research | 6 | 2015-06-04 | 2017-11-14 |
| Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade CCX168 - Immunoglobulin A Nephropathy | Phase 2 | Completed | Amgen | 7 | 2015-03-27 | 2025-03-13 |
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (10) · Vasculitis (8) · Glomerulonephritis, IGA (3) · Granulomatosis with Polyangiitis (3) · Vascular Diseases (3) · Atypical Hemolytic Uremic Syndrome (2) · Cardiovascular Diseases (2) · Microscopic Polyangiitis (2) · Abscess (1) · Glomerulonephritis, Membranoproliferative (1) · Hidradenitis Suppurativa (1) · Kidney Diseases (1) · Kidney Failure, Chronic (1) · Liver Diseases (1) · Lupus Erythematosus, Systemic (1)
Amgen (16) · Mayo Clinic (2) · Chiba University (1) · Kissei Pharmaceutical Co., Ltd. (1) · Mario Negri Institute for Pharmacological Research (1) · Robert Spiera, MD (1) · University Hospital, Toulouse (1)
United States (16) · France (5) · Belgium (4) · Canada (4) · Czechia (4) · Hungary (4) · Japan (4) · Denmark (3) · Germany (3) · Italy (3) · Netherlands (3) · Poland (3) · Spain (3) · Sweden (3) · United Kingdom (3)
Fernando Fervenza, MD (1) · Giuseppe Remuzzi, MD (1) · Lindsay Lally, MD (1) · Masayoshi Harigai, MD, PhD (1) · Nabeel Aslam, MD (1) · Robert F Spiera, MD (1) · Ulrich Specks, MD (1)
PMID 33596356, PMID 19054820, PMID 23045170, PMID 24033923, PMID 32088663, PMID 33128347, PMID 34061144, PMID 34852172, PMID 35110332, PMID 35110333, PMID 35167187, PMID 36927642, PMID 37979959, PMID 38423992, PMID 38973157, PMID 38993026, PMID 39392695, PMID 41052893, PMID 9041949
2014 (2)