Loading clinical trials...

A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT06557850•H. Lundbeck A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (6)

University Clinical Center of The Republic Of Srpska

Banja Luka, Republika Srpska, Bosnia and Herzegovina

Diagnostic-Consultative Center Alexandrovska

Sofia, Bulgaria

University Specialized Hospital for Active Treatment in Endocrinology (USHATE) "Acad. Ivan Penchev"

Sofia, Bulgaria

Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, Poland

Uniewrsyteckie Centru Kliniczne

Katowice, Poland

UnivCentrum Zdrowia MDM EB GROUP Sp.zo.o

Warsaw, Poland

Key Dates

Start Date

September 19, 2024

Primary Completion Date

March 30, 2026

Completion Date

September 29, 2026

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

Thyroid Eye Disease

Interventions

Lu AG22515

DRUG

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

NCT06112340

Thyroid Eye DiseaseGraves Orbitopathy+10 more

View study

RECRUITINGNA

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

NCT06359795

Thyroid Eye Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)

An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301