ClinicalTrials.gg
Active, not recruitingNCT07160608Updated Nov 2, 2026

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

A Phase 2 interventional study of Placebo and Tarperprumig in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, sponsored by Alexion Pharmaceuticals, Inc.. Active, not recruiting at 57 sites in 14 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 2, Interventional, and Treatment

Updated Nov 2, 2026Now Active, not recruitingEnrollment updated+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Keywords

  • ANCA-associated vasculitis
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • Vasculitis
  • IMP (Tarperprumig)
03

In context

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.

This study's enrollment of 78 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.

Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.

First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, 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 for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Tarperprumig Group 1

    Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

    Drug: Tarperprumig

  • Experimental
    Tarperprumig Group 2

    Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

    Drug: Placebo · Drug: Tarperprumig

  • Experimental
    Placebo Group 3

    Participants will be administered placebo.

    Drug: Placebo

Interventions

  • DrugPlacebo

    Participants will receive placebo.

  • Participants will receive tarperprumig.

    Also known as: ALXN1820

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline through Week 70

Secondary outcomes

  1. Number of Participants Achieving Disease Remission at Week 26

    Time frame: Week 26

  2. Number of Participants Achieving Sustained Remission at Week 52

    Time frame: Week 52

  3. Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0

    Time frame: Baseline through Week 52

  4. Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26

    Time frame: Week 26 through Week 70

  5. Time to First Relapse After Having Achieved Disease Remission at Week 26

    Time frame: Week 26 through Week 70

  6. Change from Baseline in Vasculitis Damage Index

    Time frame: Baseline, Weeks 26, and 52

  7. Time to First Occurrence of BVAS of 0

    Time frame: Baseline through Week 52

  8. Change from Baseline in BVAS

    Time frame: Baseline, Weeks 26, and 52

  9. Change from Baseline in Estimated Glomerular Filtration Rate

    Time frame: Baseline, Weeks 26, and 52

  10. Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio

    Time frame: Baseline, Weeks 26, and 52

  11. Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio

    Time frame: Baseline, Weeks 26, and 52

  12. Change from Baseline in Hematuria

    Time frame: Baseline, Weeks 26, and 52

07

Study locations

57 sites
  • Research Site
    Ciudad de Buenos Aires, C1015ABO, Argentina
  • Research Site
    Ciudad de Buenos Aires, C1181ACH, Argentina
  • Research Site
    La Plata, B1900AXI, Argentina
  • Research Site
    Rosario, S2000DEJ, Argentina
  • Research Site
    San Juan Bautista, 1888, Argentina
  • Research Site
    Clayton, 3168, Australia
  • Research Site
    Heidelberg, 3084, Australia
  • Research Site
    Nedlands, 6009, Australia
  • Research Site
    Barretos, 14784-057, Brazil
  • Research Site
    Belo Horizonte, 30130-100, Brazil
  • Research Site
    Porto Alegre, 90035-903, Brazil
  • Research Site
    São Paulo, 01323-001, Brazil
  • Research Site
    São Paulo, 04038-002, Brazil
  • Research Site
    São Paulo, 05430-010, Brazil
  • Research Site
    Calgary, Alberta T2N 1N4, Canada
  • Research Site
    Etobicoke, Ontario M9W 6V1, Canada
  • Research Site
    Hamilton, Ontario L8N 4A6, Canada
  • Research Site
    Montreal, Quebec H4J 1C5, Canada
  • Research Site
    Beijing, 100034, China
  • Research Site
    Beijing, 100730, China
  • Research Site
    Guangzhou, 510080, China
  • Research Site
    Hangzhou, 310003, China
  • Research Site
    Nanchang, 330006, China
  • Research Site
    Marseille, 13385, France
  • Research Site
    Paris, 75014, France
  • Research Site
    Strasbourg, 67091, France
  • Research Site
    Toulouse, 31059, France
  • Research Site
    Berlin, 10117, Germany
  • Research Site
    Göttingen, 37075, Germany
  • Research Site
    Ludwigshafen, 67063, Germany
  • Research Site
    Brescia, 25123, Italy
  • Research Site
    Padova, 35128, Italy
  • Research Site
    Pavia, 27100, Italy
  • Research Site
    Pisa, 56126, Italy
  • Research Site
    Gdansk, 80-214, Poland
  • Research Site
    Krakow, 30-688, Poland
  • Research Site
    Warsaw, 04-141, Poland
  • Research Site
    Daejeon, 35015, South Korea
  • Research Site
    Seoul, 08308, South Korea
  • Research Site
    Seoul, 135-710, South Korea
  • Research Site
    Barcelona, 08036, Spain
  • Research Site
    Pamplona, 31008, Spain
  • Research Site
    Seville, 41013, Spain
  • Research Site
    Taipei, 114, Taiwan
  • Research Site
    Taoyuan, 333, Taiwan
  • Research Site
    Altındağ, 06230, Turkey (Türkiye)
  • Research Site
    Ankara, 5000, Turkey (Türkiye)
  • Research Site
    Center, 23200, Turkey (Türkiye)
  • Research Site
    Istanbul, 34098, Turkey (Türkiye)
  • Research Site
    Istanbul, Turkey (Türkiye)
  • Research Site
    Kocaeli, 41380, Turkey (Türkiye)
  • Research Site
    Birmingham, B15 2GW, United Kingdom
  • Research Site
    Cambridge, CB2 0QQ, United Kingdom
  • Research Site
    Leicester, LE5 4PW, United Kingdom
  • Research Site
    London, NW3 2QG, United Kingdom
  • Research Site
    London, W12 0HS, United Kingdom
  • Research Site
    Manchester, M13 9WL, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2025
First posted
Sep 8, 2025
StartActual
Nov 26, 2025
Primary completionEst.
Oct 11, 2027
CompletionEst.
Feb 14, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 2, 2026
Sites
21 sites removed
Show 21 removed
  • Research Site · Santa Fe, Argentina
  • Research Site · Wollongong, Australia
  • Research Site · Recife, Brazil
  • Research Site · Edmonton, Canada
  • Research Site · Toronto, Canada
  • Research Site · Baotou, China
  • Research Site · Shenzhen, China
  • Research Site · Paris, France
  • Research Site · Essen, Germany
  • Research Site · München, Germany
  • Research Site · Poznan, Poland
  • Research Site · Daegu, South Korea
  • Research Site · Daegu, South Korea
  • Research Site · Seoul, South Korea
  • Research Site · Seoul, South Korea
  • Research Site · Seoul, South Korea
  • Research Site · Wŏnju, South Korea
  • Research Site · San Sebastián de los Reyes, Spain
  • Research Site · Santander, Spain
  • Research Site · Kaohsiung City, Taiwan
  • Research Site · Taichung, Taiwan
Nov 2, 2026
Enrollment
75 (estimated)→78 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Active, not recruiting
    21 sites removed
    Show 21 removed
    • Research Site · Santa Fe, Argentina
    • Research Site · Wollongong, Australia
    • Research Site · Recife, Brazil
    • Research Site · Edmonton, Canada
    • Research Site · Toronto, Canada
    • Research Site · Baotou, China
    • Research Site · Shenzhen, China
    • Research Site · Paris, France
    • Research Site · Essen, Germany
    • Research Site · München, Germany
    • Research Site · Poznan, Poland
    • Research Site · Daegu, South Korea
    • Research Site · Daegu, South Korea
    • Research Site · Seoul, South Korea
    • Research Site · Seoul, South Korea
    • Research Site · Seoul, South Korea
    • Research Site · Wŏnju, South Korea
    • Research Site · San Sebastián de los Reyes, Spain
    • Research Site · Santander, Spain
    • Research Site · Kaohsiung City, Taiwan
    • Research Site · Taichung, Taiwan
    Enrollment 75 (estimated)→78 (actual)
    + 3 other changes: identifiers, verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07160608
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Nov 26, 2025
Primary completion
Oct 11, 2027 (estimated)
Completion
Feb 14, 2028 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tarperprumig

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