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

NCT06557850 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20453A2023-508693-29-00
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

Brief 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

Keywords

Lu AG22515

Outcome Measures

Primary Outcomes (1)

• Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer

  Baseline, Week 24

Secondary Outcomes (8)

• 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

Study Arms (1)

Lu AG22515

EXPERIMENTAL

Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule.

Drug: Lu AG22515

Interventions

Lu AG22515 DRUG

Solution for infusion

Lu AG22515

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (6)

University Clinical Center of The Republic Of Srpska

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

Diagnostic-Consultative Center Alexandrovska

Sofia, 1431, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location

Uniewrsyteckie Centru Kliniczne

Katowice, 40-514, Poland

Location

UnivCentrum Zdrowia MDM EB GROUP Sp.zo.o

Warsaw, 00-189, Poland

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: September 19, 2024
• Primary Completion: March 17, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

PL (3); BO (1); BU (2)