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

Part of paid clinical trials in Los Angeles, California.

Sponsor
argenx
Study ID
NCT06307626
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/NCT06307613). 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 28, 2024
Status verified
Mar 2026
Primary completion
Dec 15, 2025
Completion
Feb 12, 2026

Study Design

Enrollment
105 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 (11)

FacilityCityStateZIPSite coordinators
American Institute of ResearchLos AngelesCalifornia90017-
North Valley Eye Medical Group, Inc.Mission HillsCalifornia91345-
Martel Eye Medical GroupRancho CordovaCalifornia95670-
Cockerham Eye ConsultantsSan DiegoCalifornia91208-
Sibia Eye InstituteBoynton BeachFlorida33437-
Sarasota Retina Institute (SRI)SarasotaFlorida34239-
Butchertown Clinical TrialsLouisvilleKentucky40206-
St. Louis University (SLU) Care - Center for Specialized MedicineSt LouisMissouri63104-
Advancing Research International, LLCLas VegasNevada89144-
New York Eye & Ear InfirmaryNew YorkNew York10003-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
American Institute of Research· Los Angeles, CANorth Valley Eye Medical Group, Inc.· Mission Hills, CAMartel Eye Medical Group· Rancho Cordova, CACockerham Eye Consultants· San Diego, CASibia Eye Institute· Boynton Beach, FLSarasota Retina Institute (SRI)· Sarasota, FL

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