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Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in participants With ANCA-associated Vasculitis
EU CTIS ID: 2023-503184-42-00
What this study is testing
To evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Newly diagnosed or relapse of GPA or MPA, 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-PR3 or anti-MPO (current or historic) antibodies.
- At least 1 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 m2 (using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equations).
You likely can't join if
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician if consulted, would pose a risk to participant safety/ interfere with the study evaluation, procedures, or completion.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study to the best of the subject and investigator’s knowledge.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase>2.0 x the upper limit of normal.
- Total bilirubin > 1.5 x the ULN. Note: a participant with documented Gilbert's syndrome with total bilirubin < 2 x ULN may be eligible
- If before signing the informed consent subject has any of the following: Received dialysis or plasma exchange within 12 weeks Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or curatively treated breast ductal carcinoma in situ within the last 5 years Active infection, or infection requiring IV anti-infective agents within 4 weeks or completion of oral anti-infective agents within 2 weeks Known COVID-19 positive test within 2 weeks History of any clinically significant cardiovascular disease within 12 weeks Received cyclophosphamide within 12 weeks; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving the cyclophosphamide or rituximab. Have been taking an oral daily dose of a glucocorticoid of >10 mg prednisone equivalent for more than 6 weeks continuously Received rituximab/B-cell depleting therapies within 26 weeks. Received any of the following within 12 weeks: - antitumor necrosis factor treatment,- abatacept,alemtuzumab,- IV Ig,belimumab,- tocilizumab Note: immunosuppressive drugs not listed here must be discussed with the medical monitor. Received a live, replication-competent vaccine within 6 weeks Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) Previously received avacopan without clinical benefit per investigator’s opinion or received avacopan within 60 days
See the full eligibility criteria
Who can join
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Newly diagnosed or relapse of GPA or MPA, 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-PR3 or anti-MPO (current or historic) antibodies.
- At least 1 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 m2 (using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equations).
What rules you out
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician if consulted, would pose a risk to participant safety/ interfere with the study evaluation, procedures, or completion.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study to the best of the subject and investigator’s knowledge.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase>2.0 x the upper limit of normal.
- Total bilirubin > 1.5 x the ULN. Note: a participant with documented Gilbert's syndrome with total bilirubin < 2 x ULN may be eligible
- If before signing the informed consent subject has any of the following: Received dialysis or plasma exchange within 12 weeks Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or curatively treated breast ductal carcinoma in situ within the last 5 years Active infection, or infection requiring IV anti-infective agents within 4 weeks or completion of oral anti-infective agents within 2 weeks Known COVID-19 positive test within 2 weeks History of any clinically significant cardiovascular disease within 12 weeks Received cyclophosphamide within 12 weeks; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving the cyclophosphamide or rituximab. Have been taking an oral daily dose of a glucocorticoid of >10 mg prednisone equivalent for more than 6 weeks continuously Received rituximab/B-cell depleting therapies within 26 weeks. Received any of the following within 12 weeks: - antitumor necrosis factor treatment,- abatacept,alemtuzumab,- IV Ig,belimumab,- tocilizumab Note: immunosuppressive drugs not listed here must be discussed with the medical monitor. Received a live, replication-competent vaccine within 6 weeks Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) Previously received avacopan without clinical benefit per investigator’s opinion or received avacopan within 60 days
- Any known multisystem autoimmune disease.
- Any medical condition requiring or expected to require use of immunosuppressive treatments, including corticosteroids that may cause confoundment with study assessments and conclusions.
- Had a kidney transplant.
- Acute/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 defined as: Positive QuantiFERON or T-SPOT test
- History of non-TB mycobacteria, opportunistic infections, without appropriate standard course of therapy meeting local guidelines.
- White blood cell count < 3500/µL, neutrophil count < 1500/µL, or lymphocyte count < 500/µL.
- Evidence of clinically significant hepatic disease
- Taking a strong/moderate inducer of the cytochrome P450 3A4 enzyme unless the strong/moderate CYP3A4 inducer can be changed to an alternative medicine.
- Female participants of childbearing potential unwilling to use protocol-specified contraception during treatment and for at least 60 days after last dose of avacopan/placebo
- Female participants who are breastfeeding, who plan to breastfeed, or who are planning to become pregnant while on study, through to 60 days after the last dose of avacopan/placebo
- Female participants with a positive pregnancy test assessed at screening and/or day 1 before randomization by a highly sensitive serum/urine pregnancy test
- Any contraindication, including known hypersensitivity to avacopan or any of the protocol-required therapies to be administered during dosing, in alignment with the local product information of those therapies.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.