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Looking for participantsPhase2

Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Sponsor: Alexion Pharmaceuticals, Inc.

NCT ID: NCT07160608

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Placebo (drug), Tarperprumig (drug)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
Placebo — drug: Participants will receive placebo. · Tarperprumig — drug: Participants will receive tarperprumig.
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at how safe and effective a medicine called tarperprumig is for adults with ANCA-associated vasculitis (a condition where the immune system attacks small blood vessels), including the GPA and MPA types. It is for people who are newly diagnosed or whose illness has come back, and whose doctors are considering treatment with rituximab or cyclophosphamide. The study is funded by Alexion Pharmaceuticals, Inc.

Who can take part

  • Adults newly diagnosed or with relapsing ANCA-associated vasculitis (GPA or MPA types), whose doctors are considering treatment with rituximab or cyclophosphamide
  • A positive blood test for PR3-ANCA or MPO-ANCA antibodies, either now or in the past
  • A certain level of disease activity, measured by a scoring tool called the BVAS (for example, at least one major item, three minor items, or two kidney items)

Who may not be able to

  • People whose main illness is another disease, such as EGPA, lupus, IgA nephropathy or IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune haemolytic anaemia, or mixed connective tissue disease
  • People with bleeding in the lungs who need invasive breathing support at screening
  • People with other diseases or conditions that the study doctor believes would make taking part too risky
  • People with a previous diagnosis of chronic kidney disease whose kidney function has been stable for more than 3 months and has fallen by less than 25% at screening

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 80 Years
Who
All
Number of participants
75
Started
2025-11-26
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for anti-neutrophil cytoplasmic antibody-associated vasculitis
  • • Phase2 - 75 participants
  • • The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with anti-neutrophil cytoplasmic antibody-associated vasculitis

Where?

  • • Birmingham - Research Site
  • • Cambridge - Research Site
  • • Leicester - Research Site
  • • London - Research Site
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for...
  • ✓At least one major item, or at least 3 minor items, or at least 2 kidney items in the BVAS.

Who cannot take part

  • ✗Alveolar hemorrhage requiring invasive lung ventilation support at Screening.
  • ✗Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to...
See the full criteria
Inclusion Criteria: * Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered. * Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay). * At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS. Exclusion Criteria: * Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease. * Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening. * Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study. * For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.

Where Is This Study? (6 UK sites)

Research Site

Birmingham B15 2GW, United Kingdom

Recruiting

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Leicester LE5 4PW, United Kingdom

Recruiting

Research Site

London NW3 2QG, United Kingdom

Recruiting

Research Site

London W12 0HS, United Kingdom

Recruiting

Research Site

Manchester M13 9WL, United Kingdom

Recruiting

How to Get in Touch

Alexion Pharmaceuticals, Inc. (Sponsor)

Sponsor contact

CONTACT

1-855-752-2356 clinicaltrials@alexion.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06