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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Eye Disease
• Intervention / Treatment: Drug: Lu AG22515

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Republika Srpska
    • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
      • University Clinical Center of the Republic of Srpska
• Bulgaria
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center Alexandrovska
  • Sofia, Bulgaria, 1431
    • University Specialized Hospital for Active Treatment in Endocrinology (USHATE) "Acad. Ivan Penchev"
• Poland
  • Katowice, Poland, 40-514
    • Uniewrsyteckie Centru Kliniczne
  • Warsaw, Poland, 00-189
    • UnivCentrum Zdrowia MDM EB GROUP Sp.zo.o
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-688
      • Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The participant has Graves' disease associated Thyroid Eye Disease (TED) symptoms characterized by:
• ophthalmologic symptom onset <12 months prior to the Baseline Visit
• proptosis ≥3 millimeter (mm) above normal for race and sex measured using the Hertel exophthalmometer (at the Screening Visit and the Baseline Visit) in the most severe eye
• Clinical Activity Score (CAS) ≥3 in the most severe eye at the Screening Visit.
• The participants must be euthyroid or have mild hypo- or hyperthyroidism (defined as free thyroxin [FT4] and/or free triiodothyronine [FT3] levels not exceeding the normal limits +/-50%) at the Screening Visit.

Exclusion Criteria:

• The participant has a decreased best-corrected visual acuity due to optic neuropathy, defined as a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or colour defect secondary to optic nerve involvement, within 6 months prior to the Screening Visit.
• The participant has corneal decompensation unresponsive to medical management.
• The participant has a decrease in proptosis of ≥2 mm between the Screening Visit and the Baseline Visit.
• The participant has a decrease in CAS of ≥2 points between the Screening Visit and the Baseline Visit.
• The participant has had previous orbital irradiation or surgery for TED.
• The participant requires immediate surgical ophthalmological intervention or has other eye conditions impacting the assessments.
• The participant has contraindications for an magnetic resonance imaging (MRI) scan.
• The participant has an active infection at Baseline or recent serious infection (for example, requiring hospitalization) within 8 weeks prior to the Baseline Visit.
• The participant takes any of the following disallowed or restricted concomitant medications (the list is not comprehensive):
• Disallowed: any investigational products within 30 days or 5 half-lives, whichever is longer, prior to the Screening Visit, systemic corticosteroids within 6 weeks prior to the Screening Visit (topical steroids for dermatological conditions, inhaled or intranasal steroids are allowed), systemic immunosuppressive/immunomodulating drugs (for example, rituximab, tocilizumab, methotrexate, cyclosporine, azathioprine, mycophenolate-sodium/mofetil, Janus kinase inhibitors) within 5 half-lives prior to the Screening Visit, live attenuated vaccines within 30 days prior to the Baseline Visit, biotin within 1 day prior to the Screening Visit.
• Allowed with restriction: stable dose for >3 weeks prior to the Screening Visit of selenium. Inactivated/killed/RNA-based vaccinations are allowed provided they are not administered within 5 days before/after any investigational medicinal product (IMP) trial visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AG22515; Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule.	Drug: Lu AG22515; Solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax: Maximum Observed Serum Concentration of Lu AG22515	Predose up to Week 52
Tmax: Time to Maximum Observed Cmax of Lu AG22515	Predose up to Week 52
Ctrough: Minimum Observed Serum Concentration of Lu AG22515	Predose up to Week 52
AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515	Predose up to Week 52
t½: Apparent Elimination Half-life of Lu AG22515	Predose up to Week 52
CL: Apparent Total Serum Clearance of Lu AG22515	Predose up to Week 52
Volume of Distribution of Lu AG22515	Predose up to Week 52
Number of Participants with Anti-drug Antibodies	Up to Week 52

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, HQ_Medinfo@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Actual): March 17, 2026
• Study Completion (Estimated): September 29, 2026

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lu AG22515
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy
• Other Study ID Numbers: 20453A; 2023-508693-29-00 (Other Identifier: CTIS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No