Thyroid Eye DiseasePhase 1NCT06557850
A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease
A Phase 1 study testing Lu AG22515 in people with Thyroid Eye Disease, run by H. Lundbeck A/S at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Lu AG22515
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 19 Sep 2024to 29 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland3 sites
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gi...
Katowice, Silesian Voivodeship, 40-514
Uniwersytet Jagiellonski Collegium Medicum (Jagiellonian University Medical College)
Krakow, Lesser Poland Voivodeship, 31-008
Centrum Zdrowia MDM EB GROUP Sp. z o.o.
Warsaw, 00-189
Bulgaria2 sites
Medical University of Sofia (MUS)-University Specialized Hospital for Active Treatment of Endocri...
Sofia, Sofia City Province, 1431
Diagnostic-Consultative Center Alexandrovska
Sofia, 1431
Bosnia and Herzegovina1 site
University Clinical Centre of the Republic of Srpska - Oncology Clinic
Banja Luka, Republika Srpska, 78000
About this study
Official title: Interventional, Open-label, Single-group, Long-term Follow-up Trial of Lu AG22515 in Patients With Moderate-to-severe Thyroid Eye Disease
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
- Being tested
- Lu AG22515
- Keywords
- Lu AG22515
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG22515Drug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Lu AG22515 | Experimental | Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule. Receives: Drug: Lu AG22515 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer
Measured: Baseline, Week 24
Secondary outcomes (8)
Cmax: Maximum Observed Serum Concentration of Lu AG22515
Measured: Predose up to Week 52
Tmax: Time to Maximum Observed Cmax of Lu AG22515
Measured: Predose up to Week 52
Ctrough: Minimum Observed Serum Concentration of Lu AG22515
Measured: Predose up to Week 52
AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515
Measured: Predose up to Week 52
t½: Apparent Elimination Half-life of Lu AG22515
Measured: Predose up to Week 52
CL: Apparent Total Serum Clearance of Lu AG22515
Measured: Predose up to Week 52
Volume of Distribution of Lu AG22515
Measured: Predose up to Week 52
Number of Participants with Anti-drug Antibodies
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start19 Sep 2024
- Primary completion17 Mar 2026
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557850
- Sponsor's protocol ID
- 20453A
- Other IDs
- 2023-508693-29-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Single-group, Long-term Follow-up Trial of Lu AG22515 in Patients With Moderate-to-severe Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06557850
- Acronym / sponsor ID
- 20453A
- Conditions
- Thyroid Eye Disease
- Keywords
- Lu AG22515
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AG22515 | Experimental | Drug: Lu AG22515Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AG22515Solution for infusion | Drug | Lu AG22515 |
Primary outcome
Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer
Time frame: Baseline, Week 24
8 secondary outcomes
Cmax: Maximum Observed Serum Concentration of Lu AG22515
Time frame: Predose up to Week 52
Tmax: Time to Maximum Observed Cmax of Lu AG22515
Time frame: Predose up to Week 52
Ctrough: Minimum Observed Serum Concentration of Lu AG22515
Time frame: Predose up to Week 52
AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515
Time frame: Predose up to Week 52
t½: Apparent Elimination Half-life of Lu AG22515
Time frame: Predose up to Week 52
CL: Apparent Total Serum Clearance of Lu AG22515
Time frame: Predose up to Week 52
Volume of Distribution of Lu AG22515
Time frame: Predose up to Week 52
Number of Participants with Anti-drug Antibodies
Time frame: Up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AG22515 in people with Thyroid Eye Disease, run by H. Lundbeck A/S at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Bulgaria, Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.