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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

- At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.

- eGFR >/= 15 mL/min/1.73 m^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).

Exclusion Criteria.

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

- Any other known multisystem autoimmune disease including 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 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 12 weeks before signing of the informed consent.

- Have had a kidney transplant.

- Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ within the last 5 years before signing the informed consent).

- Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.

- Positive test for active or latent tuberculosis during screening.

- White blood cell count < 3500/µL, neutrophil count < 1500/µL, or lymphocyte count < 500/µl.

Note: Complete Blood Count can be repeated once in the screening period per investigator discretion. In this case, eligibility will be determined based on the repeat complete blood count.

- Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis.

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >2.0 times the upper limit of normal (ULN).

- Total bilirubin > 1.5 times the ULN.

A participant with documented Gilbert's syndrome with total bilirubin < 2 x ULN may be eligible.

- Active infection and/or infection requiring oral or intravenous (IV) anti-infective agents within 4 weeks before signing of the informed consent or completion of oral anti-infective agents within 2 weeks prior to signing informed consent.

- History of any clinically significant cardiovascular disease, such as symptomatic congestive heart failure, unstable angina, myocardial infarction or stroke, within 12 weeks before signing of the informed consent.

- Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine (AZA), mycophenolate, or methotrexate at the time of screening, these drugs must be withdrawn before receiving the CYC or rituximab (RTX).

Note: If induction therapy with cyclophosphamide was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no cyclophosphamide was received within 12 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with cyclophosphamide.

- Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent.

- Received RTX or other B-cell depleting therapies within 26 weeks before signing of the informed consent.

Note: If induction therapy with rituximab was started within 1 week before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no rituximab was received within 26 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with RTX.

- Received any of the following within 12 weeks before signing the informed consent: - antitumor necrosis factor treatment.

- abatacept.

- alemtuzumab.

- IV Ig.

- belimumab.

- tocilizumab.

- Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1.

- Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before signing of the informed consent.

- Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before signing of the informed consent.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06072482
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Czechia, Hungary, Poland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Group A: Avacopan + Standard of Care (SoC)

Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.

Experimental: Group B: Avacopan/Placebo + SoC

Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.

Placebo Comparator: Group C: Placebo + SoC

Placebo twice daily for 5 years + SoC background immunosuppressive therapy.

Interventions

Drug: - Avacopan

Administered orally.

Drug: - Placebo

Administered orally.

Drug: - Standard of Care

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orthopedic Physicians Alaska, Anchorage 5879400, Alaska 5879092

Status

Terminated

Address

Orthopedic Physicians Alaska

Anchorage 5879400, Alaska 5879092, 99508

Site Contact

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