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

Phase 1

• Conditions: Active, moderate-to-severe TED; MedDRA version: 20.0Level: SOCClassification code: 10015919Term: Eye disorders Class: 9; MedDRA version: 23.1Level: LLTClassification code: 10084358Term: Thyroid eye disease Class: 100000004848; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-508693-29-00
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Principal 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified