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ANCA-associated VasculitisPhase 2NCT02222155

Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

A Phase 2 study testing CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids and CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids in people with ANCA-associated Vasculitis, run by Amgen at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Funding Source - FDA OOPD Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ANCA-associated Vasculitis
What is being tested?
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids and CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
43 sitesin 2 countries
Study dates
4 Feb 2015to 19 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis
  • Male and female subjects, aged at least 18 years, with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be required
  • Use of adequate contraception during, and for at least the three months after, any administration of study medication is required
  • Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening
  • Have at least one "major" item, or at least 3 other items, or at least 2 renal items on the Birmingham Vasculitis Activity Score (BVAS) version 3
  • Estimated glomerular filtration rate (eGFR) ≥ 20 mL per minute

Who cannot join

  • Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement
  • Any other multi-system autoimmune disease
  • Medical history of coagulopathy or bleeding disorder
  • Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
  • Received intravenous corticosteroids, >3000 mg methylprednisolone equivalent, within 12 weeks prior to screening
  • Received an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit
  • Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States39 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Aurora, Colorado

  • Study site

    Austin, Texas

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlestown, Massachusetts

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Ohio

  • Study site

    Duluth, Minnesota

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Great Neck, New York

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Kansas City, Kansas

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Miami Springs, Florida

  • Study site

    Mineola, New York

  • Study site

    New Bern, North Carolina

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Providence, Rhode Island

  • Study site

    Reno, Nevada

  • Study site

    Salt Lake City, Utah

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    Syracuse, New York

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Canada4 sites

  • Study site

    Calgary, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    Lévis, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Funding Source - FDA OOPD

Read the detailed description

Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This is a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of the C5aR inhibitor CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Being tested
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids, CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids, Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
Keywords
ANCA-associated vasculitis, complement, vasculitis, C5aR
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoidsDrug

  • CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoidsDrug

  • Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoidsOther

Study groups in NCT02222155
Study groupRoleWhat they receive
CCX168 low dose plus standard of careActive comparatorCapsule, 10 mg, twice daily + standard of care for 12 weeks
Receives: Drug: CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
CCX168 high dose plus standard of careActive comparatorCapsule, 30 mg, twice daily + standard of care for 12 weeks
Receives: Drug: CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
Placebo, twice daily + standard of carePlacebo comparatorCapsule, placebo, twice daily + standard of care for 12 weeks
Receives: Other: Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.

    Measured: Baseline to Day 85

  2. Proportion of Patients Achieving Disease Response Based on BVAS at Day 85

    Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score [BVAS] at Day 85 and no worsening in any body system component at day 85

    Measured: Day 85

Secondary outcomes (13)

  1. Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.

    Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85.

    Measured: Day 85

  2. Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.

    Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85.

    Measured: Day 29 and 85

  3. Percent Change From Baseline to Day 85 in BVAS.

    The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.

    Measured: Baseline to Day 85

  4. Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85

    Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR [Modification of Diet in Renal Disease (MDRD equation)], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells [RBC]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio).

    Measured: Day 85

  5. Change in Estimated Glomerular Filtration Rate at Day 85

    Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline.

    Measured: Baseline to Day 85

  6. Percentage Change in Estimated Glomerular Filtration Rate at Day 85

    Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula.

    Measured: Baseline to Day 85

  7. Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85

    Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline.

    Measured: Baseline to Day 85

  8. Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85

    Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline

    Measured: Baseline to Day 85

  9. Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85

    Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline

    Measured: Baseline to Day 85

  10. Change From Baseline to Day 85 in the VDI

    The Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health)

    Measured: Baseline to Day 85

  11. Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2

    Change from Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the Short Form-36 (SF-36v2) SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).

    Measured: Baseline to Day 85

  12. Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L

    Mean Change from baseline to Day 85 in health-related quality-of-life as measured by the Euro Quality-of-Life-5 Domains-5 Levels (EQ-5D-5L).

    EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).

    Measured: Baseline to Day 85

  13. Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85

    Proportion of subjects requiring rescue glucocorticoid treatment from Baseline to Day 85

    Measured: Baseline to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2014 (estimated)
  2. Study start4 Feb 2015
  3. Primary completion24 Apr 2016
  4. Study completion19 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222155
Sponsor's protocol ID
CL003_168
Other IDs
#FD-R-5414
Status last verified
Mar 2025
First submitted
19 Aug 2014
Last updated
13 Mar 2025
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Merkel PA, Niles J, Jimenez R, Spiera RF, Rovin BH, Bomback A, Pagnoux C, Potarca A, Schall TJ, Bekker P; CLASSIC Investigators. Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. ACR Open Rheumatol. 2020 Nov;2(11):662-671. doi: 10.1002/acr2.11185. Epub 2020 Oct 31.

    PubMed 33128347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids and CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids in people with ANCA-associated Vasculitis, run by Amgen at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Baseline to Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02222155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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