Status:
RECRUITING
A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Thyroid Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 peop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06557850
Start Date
September 19 2024
End Date
September 29 2026
Last Update
September 29 2025
Active Locations (6)
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1
University Clinical Center of The Republic Of Srpska
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
2
Diagnostic-Consultative Center Alexandrovska
Sofia, Bulgaria, 1431
3
University Specialized Hospital for Active Treatment in Endocrinology (USHATE) "Acad. Ivan Penchev"
Sofia, Bulgaria, 1431
4
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, Poland, 30-688