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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Subcutaneous placebo given by prefilled syringe
Thrive Health - Beverly Hills
Beverly Hills, California, United States
UCI Health - Gavin Herbert Eye Institute
Irvine, California, United States
University Of Southern California - Keck School Of Medicine
Los Angeles, California, United States
Silkiss Eye Surgery
San Francisco, California, United States
Advanced Research LLC
Coral Springs, Florida, United States
Percentage of participants who were proptosis responders
Time frame: At week 24 of the Double-Blinded Treatment Period
Change in proptosis measurement in the study eye from baseline
Time frame: Up to week 24 of the Double-Blinded Treatment Period
Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline
Minimum value: 0 (most negative impact on Quality of Life); Maximum value: 100 (No impact on Quality of Life)
Time frame: Up to week 24 of the Double-Blinded Treatment Period
Percentage of participants with a resolution of diplopia (responders)
Time frame: At week 24 of the Double-Blinded Treatment Period
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Levenson Eye Associates
Jacksonville, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
Tampa, Florida, United States
University of Illinois Chicago
Chicago, Illinois, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
...and 67 more locations