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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

H. Lundbeck A/S

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

19 Sep 2024 → ongoing

Decision date (initial)

2024-08-07

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

H. Lundbeck A/S (Lundbeck)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacokinetic, Efficacy

To evaluate the efficacy of Lu AG22515 on TED proptosis

Conditions and MedDRA coding

Active, moderate-to-severe TED

Regulatory references

Scientific advice from competent authorities

Danish Health And Medicines Authority, United States Department Of Agriculture

Plan to share IPD

Yes

IPD plan description

Lundbeck is committed to share the data from this clinical trial when the product is approved in Europe and/or the United States. Please visit www.lundbeck.com for more information about our clinical data sharing policy and processes.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. - 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. TED Proptosis 1. Primary endpoints: Change in proptosis from Baseline to Week 24 in the trial eye using the Hertel exophthalmometer

Secondary endpoints 1

1. Pharmacokinetics 1. Secondary endpoints: - exposure to Lu AG22515 as observed: Cmax, tmax, Ctrough - exposure to Lu AG22515 as modelled: AUC, CL, V, and t½; Safety 1. TEAEs 2. changes from Baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values 3. PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values; Immunogenicity 1. presence of anti-Lu AG22515 antibodies (ADAs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

H. Lundbeck A/S

Sponsor organisation

H. Lundbeck A/S

Address

Ottiliavej 9

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

H. Lundbeck A/S

Contact name

Clinical Trial Information, Lundbeck

Public contact point

Organisation

H. Lundbeck A/S

Contact name

Clinical Trial Information, Lundbeck

Third parties 7

Locations

4 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 63 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications