Health TrialsbyHealthPanel

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

ConditionAntineutrophil Cytoplasmic Antibody-associated Vasculitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAmgen

About this trial

The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants has provided informed consent before initiation of any study-specific activities/procedures.

Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.

Age >/= 18 years (or >/= legal age within the country if it is older than 18 years).

Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.

Disqualifiers

Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.

Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA [Churg-Strauss]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.

Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.

Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Avacopan

    Drug

    Administered orally.

  • Placebo

    Drug

    Administered orally.

  • Standard of Care

    Drug

    All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Group A: Avacopan + Standard of Care (SoC)Experimental treatment 2 interventions
Group B: Group B: Avacopan/Placebo + SoCExperimental treatment 3 interventions
Group C: Group C: Placebo + SoCPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to Month 60
2

Percentage of Participants Experiencing Adverse Events of Special Interest

Time frame
Up to Month 60
3

Percentage of Participants Experiencing Serious Adverse Events

Time frame
Up to Month 60
4

Percentage of Participants Experiencing Adverse Events Leading to Withdrawal

Time frame
Up to Month 60

Secondary outcomes

1

Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60

Time frame
Month 12 to Month 60
2

Group A and B Participants who Achieved Remission at Month 12: Percentage of Participants who Relapse After Achieving Remission at Month 12

Time frame
Month 12 to Month 60
3

Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60

Time frame
Month 60
4

Group A and C Participants with Overt Renal Disease at Baseline: Change from Baseline to Month 60 in Estimated Glomerular Filtration Rate (eGFR)

Time frame
Baseline and Month 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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