Immunoglobulin A NephropathyPhase 3NCT07890909
A Phase 3b Study of Participant Experience on Povetacicept Administered Via Autoinjector as Compared to Sibeprenlimab Administered Via Prefilled Syringe
A Phase 3 study testing Povetacicept and Sibeprenlimab in people with Immunoglobulin A Nephropathy, run by Vertex Pharmaceuticals Incorporated.
Trial summary
The purpose of this study is to evaluate participant treatment experience with Povetacicept injection administered via autoinjector relative to Sibeprenlimab injection administered via prefilled syringe (PFS), and to assess the safety and tolerability of Povetacicept in participants with Immunoglobulin A nephropathy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- Povetacicept and Sibeprenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 2 Mar 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving commercial sibeprenlimab 400 mg subcutaneous via PFS for up to (but not exceeding) a maximum of 4 doses of which at least 1 dose is self-injected prior to signing informed consent form
- Willing and able to comply with scheduled visits, treatment plan including transitioning to povetacicept
- Biopsy-confirmed primary IgAN
- 24-hr urine protein/creatinine ratio (UPCR) greater than >0.5 gram (g)/g
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 millilitres per minute (mL/min)/1.73 square meter (m^2)
- Able to understand and complete the domains of the Self-Injection Administration Questionnaire (SIAQ)
Who cannot join
- Use of immunosuppressive or immunomodulatory therapies (except for sibeprenlimab)
- Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3b, Open-label, Single-arm, Patient Experience Study of Povetacicept Injection (Via Autoinjector) as Compared to Sibeprenlimab Injection (Via Prefilled Syringe) in Adults With Immunoglobulin A Nephropathy
The purpose of this study is to evaluate participant treatment experience with Povetacicept injection administered via autoinjector relative to Sibeprenlimab injection administered via prefilled syringe (PFS), and to assess the safety and tolerability of Povetacicept in participants with Immunoglobulin A nephropathy (IgAN).
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- Povetacicept, Sibeprenlimab
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Also called ALPN-303
Subcutaneous injection administration.
SibeprenlimabDrug
Subcutaneous injection administration.
| Study group | Role | What they receive |
|---|---|---|
| Povetacicept | Experimental | Participants previously receiving Sibeprenlimab will self-administer Povetacicept. Receives: Drug: Povetacicept; Drug: Sibeprenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Self-Injection Administration Questionnaire (SIAQ) Scores at Week 12 After Transitioning to Povetacicept Injection
Measured: Baseline up to Week 12
Secondary outcomes (1)
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Signing of Informed Consent up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion12 Dec 2027 (estimated)
- Study completion2 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890909
- Sponsor's protocol ID
- VX26-AIS-902
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-label, Single-arm, Patient Experience Study of Povetacicept Injection (Via Autoinjector) as Compared to Sibeprenlimab Injection (Via Prefilled Syringe) in Adults With Immunoglobulin A Nephropathy
- ClinicalTrials.gov ID
- NCT07890909
- Acronym / sponsor ID
- VX26-AIS-902
- Conditions
- Immunoglobulin A Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 2 Mar 2028 (estimated)
- First posted
- 22 Oct 2026 (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 purpose of this study is to evaluate participant treatment experience with Povetacicept injection administered via autoinjector relative to Sibeprenlimab injection administered via prefilled syringe (PFS), and to assess the safety and tolerability of Povetacicept in participants with Immunoglobulin A nephropathy (IgAN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Povetacicept | Experimental | Drug: Povetacicept, Drug: SibeprenlimabParticipants previously receiving Sibeprenlimab will self-administer Povetacicept. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Receiving commercial sibeprenlimab 400 mg subcutaneous via PFS for up to (but not exceeding) a maximum of 4 doses of which at least 1 dose is self-injected prior to signing informed consent form
- Willing and able to comply with scheduled visits, treatment plan including transitioning to povetacicept
- Biopsy-confirmed primary IgAN
- 24-hr urine protein/creatinine ratio (UPCR) greater than >0.5 gram (g)/g
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 millilitres per minute (mL/min)/1.73 square meter (m^2)
Key exclusion criteria (3 listed)
- Use of immunosuppressive or immunomodulatory therapies (except for sibeprenlimab)
- Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening
- Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| PovetaciceptAlso: ALPN-303Subcutaneous injection administration. | Drug | Povetacicept |
| SibeprenlimabSubcutaneous injection administration. | Drug | Povetacicept |
Primary outcome
Change from Baseline in the Self-Injection Administration Questionnaire (SIAQ) Scores at Week 12 After Transitioning to Povetacicept Injection
Time frame: Baseline up to Week 12
1 secondary outcome
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Signing of Informed Consent up to Week 24
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 22 Oct 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Povetacicept and Sibeprenlimab in people with Immunoglobulin A Nephropathy, run by Vertex Pharmaceuticals Incorporated.
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 3 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Self-Injection Administration Questionnaire (SIAQ) Scores at Week 12 After Transitioning to Povetacicept Injection (time frame: Baseline up to Week 12). 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 22 Oct 2026.