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

ConditionMyasthenia Gravis, Generalized

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorVertex Pharmaceuticals Incorporated

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to (>=) 18 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Povetacicept
Drug
Solution for Subcutaneous Injection.
Placebo
Drug
Solution for Subcutaneous Injection.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: PovetaciceptExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Percent change in Total Immunoglobulin G (IgG)

Time frame

Baseline and At Week 12

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

Time frame

From Baseline Up to Week 116

Sponsors and contacts

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Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov

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