RECRUITINGPhase 2

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

30 participants

Sites

3 locations

Start Date

April 2026

Completion

March 2029

Myasthenia Gravis, GeneralizedPovetaciceptPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

2.9 years

total trial span

Rate

pts/month needed

Apr 2026Month 0 of 35Mar 2029

0% of trial timeline elapsed35 months to primary endpoint

At 3 sites, each site needs to enroll approximately 0.3 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

Percent change in Total Immunoglobulin G (IgG)

Baseline and At Week 12

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

From Baseline Up to Week 116

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…

RECRUITINGPhase 2

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

30 participants

Sites

3 locations

Start Date

April 2026

Completion

March 2029

Myasthenia Gravis, GeneralizedPovetaciceptPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

2.9 years

total trial span

Rate

pts/month needed

Apr 2026Month 0 of 35Mar 2029

0% of trial timeline elapsed35 months to primary endpoint

At 3 sites, each site needs to enroll approximately 0.3 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

Percent change in Total Immunoglobulin G (IgG)

Baseline and At Week 12

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

From Baseline Up to Week 116

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

Max Age

80 Years

Sex

all

Healthy Volunteers

View full criteria

Key Inclusion Criteria:

* Age 18-80 years
* Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV
* Additional inclusion criteria are defined in the protocol

Key Exclusion Criteria:

* History of thymic surgery within 6 months of screening
* History of malignancy within the last 5 years
* Additional exclusion criteria are defined in the protocol

Other protocol defined Inclusion/Exclusion criteria will apply.

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (3)