A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease

This clinical trial (LASN01-CL-2201) comprises a multiple-dose design in 3 parallel treatment arms for patients with TED with no prior anti-IGF-1R treatment, and a 4th treatment arm for patients with TED who have previously received teprotumumab treatment.

Inclusion criteria

• Male or female patients ≥18 years of age at the time of Screening
• Clinical diagnosis of Graves' disease associated with active TED
• Moderate-to-severe active TED
• Female patients must be nonpregnant, nonlactating, surgically sterile for ≥6 months, or agree to use a highly effective method of contraception. Males must be surgically sterile or agree to use a highly effective method of contraception.
• No previous:

• Medical treatment for TED, with the exception of:

• Local supportive measures;
• Mycophenolate, and oral or injectable steroids;
• Immunomodulating therapies
• For the open-label treatment arm only: Previous treatment with teprotumumab is required.
• Orbital surgery
• Orbital radiation
• Patients

• Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms
• With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease

Exclusion criteria

• Patients with 2 mm proptosis decrease between Screening and Day 1, or a 1-point decrease on the CAS 7-point scale between Screening and Day 1
• Patients with a known decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 3 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening; or any known optic neuropathy or compression or any neurologic or neuro-ophthalmologic condition that may result in visual field loss.
• Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU)
• Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Day 1 (topical steroids for conditions other than TED are allowed)
• Active autoimmune disorder(s) requiring or likely to require treatment (other than Grave's disease and TED) that would interfere with study assessments, as determined by the PI or designee
• Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time, with exception to the open-label post-teprotumumab treatment arm where prior use of teprotumumab is required
• Use of selenium within 3 weeks before Day 1 or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses)
• Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection