Investigating Lu AG22515 for 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 study is testing if a new treatment called Lu AG22515 can help adults with moderate-to-severe thyroid eye disease reduce eye bulging and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lundbeck A/S Industry-sponsored |
| Drugs / interventions | rituximab, tocilizumab, methotrexate |
| Locations | 5 sites (Banja Luka, Republika Srpska and 4 other locations) |
| Trial ID | NCT06557850 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of Lu AG22515 in adults suffering from moderate-to-severe thyroid eye disease (TED), an autoimmune condition linked to Graves' Disease. The study aims to determine if this treatment can improve proptosis, a key symptom characterized by bulging eyes. Participants will be assessed based on specific criteria, including the severity of their symptoms and thyroid hormone levels. The trial is designed to gather data on the efficacy of Lu AG22515 in alleviating the symptoms of TED.
Who should consider this trial
Good fit: Ideal candidates are adults with Graves' disease-related thyroid eye disease symptoms, specifically those with proptosis and a Clinical Activity Score indicating moderate to severe disease.
Not a fit: Patients with optic neuropathy or significant visual impairment due to thyroid eye disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate-to-severe thyroid eye disease.
How similar studies have performed: While this approach is novel, previous studies have explored treatments for thyroid eye disease, but the specific efficacy of Lu AG22515 remains untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Banja Luka, Republika Srpska and 4 other locations
- University Clinical Center of The Republic Of Srpska — Banja Luka, Republika Srpska, Bosnia and Herzegovina (Recruiting)
- Diagnostic-Consultative Center Alexandrovska — Sofia, Bulgaria (Recruiting)
- University Specialized Hospital for Active Treatment in Endocrinology (USHATE) "Acad. Ivan Penchev" — Sofia, Bulgaria (Recruiting)
- Jagiellonian University Medical College — Krakow, Lesser Poland Voivodeship, Poland (Recruiting)
- Uniewrsyteckie Centru Kliniczne — Katowice, Poland (Recruiting)
Study contacts
- Study coordinator: Email contact via H. Lundbeck A/S
- Email: LundbeckClinicalTrials@Lundbeck.com
- Phone: +45 36301311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.