NCT06307626

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

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efgartigimod PH20 SC	Subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHER	Placebo PH20 SC	Subcutaneous placebo given by prefilled syringe

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-12-15
• Completion: 2026-02-12
• First posted: 2024-03-13
• Last updated: 2026-03-16

Locations

76 sites across 18 countries: United States, Austria, Bulgaria, China, France, Georgia, Germany, Italy, Japan, Latvia, Poland, Serbia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study