ENROLLING BY INVITATIONPhase 3

A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

605 participants

Sites

3 locations

Start Date

September 2026

Completion

December 2029

Immunoglobulin A NephropathyPovetacicept

Enrollment & Timeline

ENROLLING BY INVITATION

Target enrollment (estimated)

Target N

605

participants

Sites

locations

Duration

3.3 years

total trial span

Rate

pts/month needed

Sep 2026Month 1 of 39Dec 2029

3% of trial timeline elapsed38 months to primary endpoint

At 3 sites, each site needs to enroll approximately 5.3 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Primary Outcomes

Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

From Day 1 up to Week 112

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

ENROLLING BY INVITATIONPhase 3

A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

605 participants

Sites

3 locations

Start Date

September 2026

Completion

December 2029

Immunoglobulin A NephropathyPovetacicept

Enrollment & Timeline

ENROLLING BY INVITATION

Target enrollment (estimated)

Target N

605

participants

Sites

locations

Duration

3.3 years

total trial span

Rate

pts/month needed

Sep 2026Month 1 of 39Dec 2029

3% of trial timeline elapsed38 months to primary endpoint

At 3 sites, each site needs to enroll approximately 5.3 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

From Day 1 up to Week 112

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Sex

all

Healthy Volunteers

View full criteria

Key Inclusion Criteria:

* Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug
* Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m\^2) within 45 days of Day 1 of this study

Key Exclusion Criteria:

\- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).

Other protocol defined Inclusion/Exclusion criteria may apply.

A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (3)