Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisPhase 2NCT07160608
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
A Phase 2 study testing Tarperprumig in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Alexion Pharmaceuticals, Inc. at 57 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- What is being tested?
- Tarperprumig
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 57 sitesin 14 countries
- Study dates
- 26 Nov 2025to 14 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
57 sites in 14 countries.
57 sites in 14 countries
Brazil6 sites
Research Site
Barretos, 14784-057
Research Site
Belo Horizonte, 30130-100
Research Site
Porto Alegre, 90035-903
Research Site
São Paulo, 01323-001
Research Site
São Paulo, 04038-002
Research Site
São Paulo, 05430-010
Turkey (Türkiye)6 sites
Research Site
Altındağ, 06230
Research Site
Ankara, 5000
Research Site
Center, 23200
Research Site
Istanbul, 34098
Research Site
Istanbul
Research Site
Kocaeli, 41380
United Kingdom6 sites
Research Site
Birmingham, B15 2GW
Research Site
Cambridge, CB2 0QQ
Research Site
Leicester, LE5 4PW
Research Site
London, NW3 2QG
Research Site
London, W12 0HS
Research Site
Manchester, M13 9WL
Argentina5 sites
Research Site
Ciudad de Buenos Aires, C1015ABO
Research Site
Ciudad de Buenos Aires, C1181ACH
Research Site
La Plata, B1900AXI
Research Site
Rosario, S2000DEJ
Research Site
San Juan Bautista, 1888
China5 sites
Research Site
Beijing, 100034
Research Site
Beijing, 100730
Research Site
Guangzhou, 510080
Research Site
Hangzhou, 310003
Research Site
Nanchang, 330006
Canada4 sites
Research Site
Calgary, Alberta, T2N 1N4
Research Site
Etobicoke, Ontario, M9W 6V1
Research Site
Hamilton, Ontario, L8N 4A6
Research Site
Montreal, Quebec, H4J 1C5
France4 sites
Research Site
Marseille, 13385
Research Site
Paris, 75014
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31059
Italy4 sites
Research Site
Brescia, 25123
Research Site
Padova, 35128
Research Site
Pavia, 27100
Research Site
Pisa, 56126
Australia3 sites
Research Site
Clayton, 3168
Research Site
Heidelberg, 3084
Research Site
Nedlands, 6009
Germany3 sites
Research Site
Berlin, 10117
Research Site
Göttingen, 37075
Research Site
Ludwigshafen, 67063
Poland3 sites
Research Site
Gdansk, 80-214
Research Site
Krakow, 30-688
Research Site
Warsaw, 04-141
South Korea3 sites
Research Site
Daejeon, 35015
Research Site
Seoul, 08308
Research Site
Seoul, 135-710
Spain3 sites
Research Site
Barcelona, 08036
Research Site
Pamplona, 31008
Research Site
Seville, 41013
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)
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.
- Being tested
- Placebo, Tarperprumig
- Keywords
- ANCA-associated vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, IMP (Tarperprumig)
- 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.
PlaceboDrug
Participants will receive placebo.
TarperprumigDrug
Also called ALXN1820
Participants will receive tarperprumig.
| Study group | Role | What they receive |
|---|---|---|
| Tarperprumig Group 1 | Experimental | Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. Receives: Drug: Tarperprumig |
| Tarperprumig Group 2 | Experimental | Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. Receives: Drug: Placebo; Drug: Tarperprumig |
| Placebo Group 3 | Experimental | Participants will be administered placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline through Week 70
Secondary outcomes (12)
Number of Participants Achieving Disease Remission at Week 26
Measured: Week 26
Number of Participants Achieving Sustained Remission at Week 52
Measured: Week 52
Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0
Measured: Baseline through Week 52
Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26
Measured: Week 26 through Week 70
Time to First Relapse After Having Achieved Disease Remission at Week 26
Measured: Week 26 through Week 70
Change from Baseline in Vasculitis Damage Index
Measured: Baseline, Weeks 26, and 52
Time to First Occurrence of BVAS of 0
Measured: Baseline through Week 52
Change from Baseline in BVAS
Measured: Baseline, Weeks 26, and 52
Change from Baseline in Estimated Glomerular Filtration Rate
Measured: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio
Measured: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio
Measured: Baseline, Weeks 26, and 52
Change from Baseline in Hematuria
Measured: Baseline, Weeks 26, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start26 Nov 2025
- Primary completion11 Oct 2027 (estimated)
- Study completion14 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160608
- Sponsor's protocol ID
- D6722C00001
- Other IDs
- 2025-521706-17-00, ALXN1820-ANCA-201, 2025
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)
- ClinicalTrials.gov ID
- NCT07160608
- Acronym / sponsor ID
- D6722C00001
- Keywords
- ANCA-associated vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, IMP (Tarperprumig)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 11 Oct 2027 (estimated)
- Study completion
- 14 Feb 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tarperprumig Group 1 | Experimental | Drug: TarperprumigParticipants will be administered tarperprumig dose regimen #1 or dose regimen #2. |
| Tarperprumig Group 2 | Experimental | Drug: Placebo, Drug: TarperprumigParticipants will be administered tarperprumig dose regimen #1 or dose regimen #2. |
| Placebo Group 3 | Experimental | Drug: PlaceboParticipants will be administered placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive placebo. | Drug | Placebo Group 3, Tarperprumig Group 2 |
| TarperprumigAlso: ALXN1820Participants will receive tarperprumig. | Drug | Tarperprumig Group 1, Tarperprumig Group 2 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 70
12 secondary outcomes
Number of Participants Achieving Disease Remission at Week 26
Time frame: Week 26
Number of Participants Achieving Sustained Remission at Week 52
Time frame: Week 52
Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0
Time frame: Baseline through Week 52
Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26
Time frame: Week 26 through Week 70
Time to First Relapse After Having Achieved Disease Remission at Week 26
Time frame: Week 26 through Week 70
Change from Baseline in Vasculitis Damage Index
Time frame: Baseline, Weeks 26, and 52
Time to First Occurrence of BVAS of 0
Time frame: Baseline through Week 52
Change from Baseline in BVAS
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Estimated Glomerular Filtration Rate
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Hematuria
Time frame: Baseline, Weeks 26, and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarperprumig in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Alexion Pharmaceuticals, Inc. at 57 sites in 14 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Brazil, Turkey (Türkiye), United Kingdom, Argentina, China and 9 more countries. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline through Week 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.