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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.

Sponsored by Amgen

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 12, 2026

Phase

Clinical Trial

Sponsor

Amgen

Enrollment Target

20

Start Date

Oct 2024

πŸ“Š
1 of 20 participants interested
5% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.

Who Can Participate

Inclusion Criteria

Male and female children and adolescents from 6 to \< 18 years of age
Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013)
Newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
At least 1 PVAS major item, at least 3 PVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
eGFR \> 15 mL/min/1.73 m2 (using modified Schwartz equation per central lab guidelines)
Participants must have a bodyweight of β‰₯ 15 kg at day 1.

Exclusion Criteria

Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus , IgA vasculitis (Henoch-SchΓΆnlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
Alveolar hemorrhage requiring invasi

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

πŸ“‹

Study Type

INTERVENTIONAL

πŸ‘₯

Target Enrollment

20 participants

πŸŽ‚

Age Range

6 Years - 17 Years

⚧

Gender

ALL

🏒

Sponsor

Amgen

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
RECRUITING

Minneapolis

Minnesota

Location available
View Minneapolis location page
RECRUITING

Lake Success

New York

Location available
View Lake Success location page
RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page
RECRUITING

Charlotte

North Carolina

Location available
View Charlotte location page
RECRUITING

Akron

Ohio

Location available
View Akron location page
RECRUITING

Cleveland

Ohio

Location available
View Cleveland location page
RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page

πŸ“ And 1 more location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for Granulomatosis with polyangiitis Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Granulomatosis with polyangiitis Treatment Options in Atlanta, Georgia

If you're searching for Granulomatosis with polyangiitis treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta, Indianapolis, Minneapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Granulomatosis with polyangiitis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Granulomatosis with polyangiitis?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Granulomatosis with polyangiitis

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Granulomatosis with polyangiitis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06321601. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.