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

Completed · Phase 2 · Has a placebo group

Conditions studied: Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy, Thyroid Associated Ophthalmopathy, Endocrine System Diseases, Orbital Diseases, Proptosis, Eye Diseases

In brief

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED). The primary and secondary objectives of this study are to evaluate the treatment effect, safety, and pharmacokinetics of LASN01 administered IV in patients with TED with no prior anti-IGF-1R treatment or in patients with TED who have previously received teprotumumab treatment.

Key facts

Study ID

NCT06226545

Run by

Lassen Therapeutics Inc.

People needed

41

Starts

2024-03-05

Expected to finish

2025-04-22

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 111 — Beverly Hills, California, United States
• Site 105 — Palo Alto, California, United States
• Site 101 — San Diego, California, United States
• Site 103 — Miami, Florida, United States
• Site 108 — Livonia, Michigan, United States
• Site 112 — Las Vegas, Nevada, United States
• Site 110 — Wilmington, North Carolina, United States
• Site 106 — Houston, Texas, United States
• Site 104 — Houston, Texas, United States
• Site 109 — Seattle, Washington, United States
• Site 302 — Córdoba, Spain
• Site 301 — Seville, Spain
• Site 201 — London, United Kingdom
• Site 206 — London, United Kingdom
• Site 204 — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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