A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease

Part of paid clinical trials in Beverly Hills, California.

Sponsor
argenx
Study ID
NCT06307613
Phase
PHASE3
Status
Terminated

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

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

Interventions

  • Efgartigimod PH20 SC — COMBINATION_PRODUCT
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Placebo PH20 SC — OTHER
    Subcutaneous placebo given by prefilled syringe

Study Details

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks. An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626). This study was terminated early on 15 December 2025 as the pre-defined interim analysis concluded that continuing the trials is unlikely to demonstrate the intended efficacy. This decision is not related to safety concerns, and the safety profile of efgartigimod remains unchanged. End-of-study and Safety-Follow-Up visits are ongoing for the participants of this trial.

Key Dates

Start date
Mar 27, 2024
Status verified
Mar 2026
Primary completion
Dec 15, 2025
Completion
Feb 12, 2026

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod arm
    Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)
  • Placebo Comparator: Placebo arm
    Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)

Primary Outcome Measure

Percentage of participants who were proptosis responders [ Time Frame: At week 24 of the Double-Blinded Treatment Period ]

Locations (16)

FacilityCityStateZIPSite coordinators
Thrive Health - Beverly HillsBeverly HillsCalifornia90210-
UCI Health - Gavin Herbert Eye InstituteIrvineCalifornia92697-
University Of Southern California - Keck School Of MedicineLos AngelesCalifornia90033-
Silkiss Eye SurgerySan FranciscoCalifornia94102-
Advanced Research LLCCoral SpringsFlorida33067-
Levenson Eye AssociatesJacksonvilleFlorida32204-
Bascom Palmer Eye InstituteMiamiFlorida33136-
University of South Florida (USF) Health - Morsani Center for Advanced HealthcareTampaFlorida33612-
University of Illinois ChicagoChicagoIllinois60612-
Wilmer Eye InstituteBaltimoreMaryland21205-
University of MichiganAnn ArbourMichigan48105-
Moyes Eye Center - NorthlandKansas CityMissouri64154-
Quest Diagnostics - Mercy Smith Glynn CallawaySpringfieldMissouri65807-
Duke UniversityDurhamNorth Carolina27705-
Penn Medicine - Penn Presbyterian Medical Center - Scheie Eye InstitutePhiladelphiaPennsylvania19104-
West Virginia University Eye InstituteMorgantownWest Virginia26506-

Find similar trials in Beverly Hills, CA

By research site
Thrive Health - Beverly Hills· Beverly Hills, CAUCI Health - Gavin Herbert Eye Institute· Irvine, CAUniversity Of Southern California - Keck School Of Medicine· Los Angeles, CASilkiss Eye Surgery· San Francisco, CAAdvanced Research LLC· Coral Springs, FLLevenson Eye Associates· Jacksonville, FL

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