NCT06557850

A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease

Interventional, Open-label, Single-group, Long-term Follow-up Trial of Lu AG22515 in Patients With Moderate-to-severe Thyroid Eye Disease

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease. In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	Lu AG22515	Solution for infusion

Timeline

• Start date: 2024-09-19
• Primary completion: 2026-03-17
• Completion: 2026-09-29
• First posted: 2024-08-16
• Last updated: 2026-04-15

Locations

6 sites across 3 countries: Bosnia and Herzegovina, Bulgaria, Poland

Regulatory

• FDA-regulated drug study