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NCT06307626 · ClinicalTrials.gov registry record · Phase 3
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
A Phase 3 study, sponsored by argenx.
- Terminated
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT06307626 is a Phase 3 study that was terminated before completion, run by argenx. The registered enrollment target is 105 participants.
The verdict
NCT06307626, a Phase 3 study, was terminated before completion, sponsored by argenx.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study 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.
Interventions
- COMBINATION_PRODUCT Efgartigimod PH20 SC
- OTHER Placebo PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2026-02-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06307626
The ClinicalTrials.gov registry entry for NCT06307626 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Efgartigimod PH20 SC is the first listed.
NCT06307626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06307626 about?
NCT06307626 is a clinical study titled "A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.". 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 r...
What is the current status of trial NCT06307626?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2024-03-28. Estimated completion is 2026-02-12.
What interventions are being tested in trial NCT06307626?
The interventions under investigation include: Efgartigimod PH20 SC (COMBINATION_PRODUCT), Placebo PH20 SC (OTHER).
Who is sponsoring clinical trial NCT06307626?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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