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

Launched by H. LUNDBECK A/S · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Lu AG22515 for adults with moderate-to-severe thyroid eye disease (TED), which is a condition that can cause symptoms like bulging eyes. TED often occurs in people with Graves' disease, an autoimmune disorder. The main goal of this study is to see if Lu AG22515 can help reduce the bulging of the eyes in those affected by TED.

To participate in the trial, individuals need to have experienced TED symptoms for less than a year and have noticeable bulging in their eyes, along with a specific score that indicates the severity of their condition. Participants will be adults aged 18 and older, and they should not have had recent serious eye problems or certain treatments that could interfere with the study. Those who join can expect regular check-ups and assessments to monitor their condition and the effects of the new treatment. Overall, this trial aims to provide valuable information that could improve the care for people living with thyroid eye disease.

Gender

ALL

Eligibility criteria

• 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.