Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

Part of paid clinical trials in Carlsbad, California.

Sponsor
argenx
Study ID
NCT04818671
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Key Dates

Start date
Apr 26, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
184 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod PH20 SC
    Patients receiving efgartigimod PH20 subcutaneous (SC) treatment

Primary Outcome Measure

Number of AEs, SAEs and AESIs [ Time Frame: Up to 3.5 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
Investigator site 6 - US0010032CarlsbadCalifornia92011-
Investigator Site 47 - US0010021Palo AltoCalifornia94304-
Investigator Site 45 - US0010108Boca RatonFlorida33428-
Investigator site 4 - US0010110Port CharlotteFlorida33952-
Investigator Site 39 - US0010006TampaFlorida41076-
Investigator Site 41 - US0010015Kansas CityKansas66160-
Investigator Site 46 - US0010111AmherstNew York14226-
Investigator Site 38 - US0010003Chapel HillNorth Carolina27514-
Investigator Site 44 - US0010077DurhamNorth Carolina27710-
Investigator Site 42 - US0010019ClevelandOhio44195-
Investigator site 7 - US0010008CordovaTennessee38018-
Investigator Site 43 - US0010066AustinTexas78759-
Investigator Site 40 - US0010009San AntonioTexas78229-

Find similar trials in Carlsbad, CA

By research site
Investigator site 6 - US0010032· Carlsbad, CAInvestigator Site 47 - US0010021· Palo Alto, CAInvestigator Site 45 - US0010108· Boca Raton, FLInvestigator site 4 - US0010110· Port Charlotte, FLInvestigator Site 39 - US0010006· Tampa, FLInvestigator Site 41 - US0010015· Kansas City, KS

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