HUMAN (SCFV)2-FAB FUSION PROTEIN AGAINST CD40L for Thyroid eye disease | Graves' disease

Inclusion criteria

• {"criterion_text":"- Principal inclusion criteria: - The participant has Graves’ disease associated Thyroid Eye Disease (TED) symptoms characterized by:\n- ophthalmologic symptom onset <12 months prior to the Baseline Visit\n- 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\n- Clinical Activity Score (CAS) ≥3 in the most severe eye at the Screening Visit.\n- 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

• {"criterion_text":"- 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.\n- The participant has corneal decompensation unresponsive to medical management.\n- The participant has a decrease in proptosis of ≥2 mm between the Screening Visit and the Baseline Visit.\n- The participant has a decrease in CAS of ≥2 points between the Screening Visit and the Baseline Visit.\n- The participant has had previous orbital irradiation or surgery for TED.\n- The participant requires immediate surgical ophthalmological intervention or has other eye conditions impacting the assessments.\n- The participant has contraindications for an magnetic resonance imaging (MRI) scan.\n- The participant has an active infection at Baseline or recent serious infection (for example, requiring hospitalization) within 8 weeks prior to the Baseline Visit.\n- The participant takes any of the following disallowed or restricted concomitant medications (the list is not comprehensive):\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- TED Proptosis 1. Primary endpoints: Change in proptosis from Baseline to Week 24 in the trial eye using the Hertel exophthalmometer","definition_or_measurement_approach":"Change in proptosis from Baseline to Week 24 in the trial eye measured using the Hertel exophthalmometer"}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Pharmacokinetics: observed exposure measures (Cmax, tmax, Ctrough) and modelled exposure (AUC, CL, V, t½); Safety: TEAEs, changes from Baseline in clinical safety laboratory tests, vital signs, weight, ECG parameters; Immunogenicity: presence of anti-Lu AG22515 antibodies (ADAs)"}

Methods

• Country-specific recruitment arrangements documents (K1) available
• Patient flyers (K2) for specific sites (e.g. Poland patient flyers)
• Referral letters (K2_Referral Letter_POL) for site referrals
• Site-based recruitment through participating hospitals/clinics (site contact details provided)

Bulgaria

Earliest CTIS Part Ii Submission Date

08-07-2024

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

414

Number Of Sites

2

Number Of Participants

4

Poland

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

418

Number Of Sites

3

Number Of Participants

7

Germany

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

45

Number Of Sites

1

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

01-05-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

117

Number Of Sites

2

Number Of Participants

3

Primary sponsor

Full Name

H. Lundbeck A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Clario

Responsibilities

MRI central reading

Name

Clinical Outcomes Solutions Limited

Responsibilities

Perform Patient's Interview

Name

Celerion

Responsibilities

Sample management / clinical services (contact listed: sample.management@celerion.com)

Name

Signant Health Global Solutions Limited

Responsibilities

Go QOL validation and site rater's training

Name

Medicover Integrated Clinical Services Sp. z o.o.

Name

Eresearchtechnology Inc.

Responsibilities

Cardiac safety assessment central reading

Name

Celerion Inc.

Third parties

• {"country":"United States","full_name":"Clario","duties_or_roles":"MRI central reading","organisation_type":"Health care"}
• {"country":"United Kingdom","full_name":"Clinical Outcomes Solutions Limited","duties_or_roles":"Perform Patient's Interview","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Go QOL validation and site rater's training","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Medicover Integrated Clinical Services Sp. z o.o.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac safety assessment central reading","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}