What is the mechanism of action of this treatment?

Graves' Ophthalmopathy, also known as Thyroid Eye Disease (TED), is commonly treated with medications that target the immune system to reduce inflammation and autoimmunity. Treatments include glucocorticoids, which inhibit peripheral conversion of T4 to T3 and reduce thyroid secretion, and monoclonal antibodies like teprotumumab, which target the IGF-1 receptor to reduce inflammation and tissue expansion behind the eyes. The novel treatment LASN01, an IL-11 receptor antagonist, aims to block the IL-11 pathway, potentially reducing inflammation and fibrosis in the orbital tissues. Understanding these mechanisms is crucial for patients as it helps them comprehend how these treatments can alleviate symptoms, prevent disease progression, and improve quality of life by targeting specific pathways involved in the disease process.

What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy include teprotumumab, an IGF-1R antagonist, and corticosteroids. Teprotumumab can cause muscle spasms, nausea, alopecia, diarrhea, fatigue, and hyperglycemia. Corticosteroids, often used in high doses, can lead to side effects such as hyperglycemia, increased susceptibility to infections, bone loss, fractures, and neuropsychiatric effects. Both treatments require careful monitoring to manage these potential adverse effects.

What prior FDA approvals exist?

Teprotumumab, an IGF-1R antibody, is a notable FDA-approved treatment for Thyroid Eye Disease (TED). It has shown significant efficacy in reducing the signs and symptoms of TED. While there is no specific mention of FDA-approved IL-11 receptor antagonists for TED, the study of LASN01, a novel IL-11 receptor antagonist, represents a similar approach in targeting specific immune pathways involved in the disease. Other treatments for TED often involve corticosteroids, radiation therapy, and surgical interventions, but these are not directly comparable to the targeted biologic therapies like teprotumumab and LASN01.

What other types of research exist?

Promising alternatives to LASN01 for Graves' Ophthalmopathy patients include teprotumumab, an IGF-1R antagonist, which has shown efficacy in clinical trials. Additionally, treatments targeting IL-23, such as risankizumab, and IL-17 pathway inhibitors, like secukinumab, may offer potential benefits due to their roles in immune-mediated disorders.

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Monoclonal Antibodies

LASN01 for Thyroid Eye Disease

Phase 2

Waitlist Available

Research Sponsored by Lassen Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients ≥18 years of age at the time of Screening

Clinical diagnosis of Graves' disease associated with active TED

Must not have

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

Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing LASN01, a human protein-based medicine, in patients with thyroid eye disease. It aims to help those who haven't had certain treatments before and those who have already tried teprotumumab. The medicine works by blocking part of the immune system to reduce eye problems.

Who is the study for?

This trial is for patients with Thyroid Eye Disease (TED), a condition often associated with Graves' disease, causing eye problems like bulging eyes. Participants should have active symptoms and be suitable for intravenous treatment.

What is being tested?

The study tests LASN01, an antibody targeting the IL-11 receptor, which could help treat TED. Patients will receive one of two different doses of LASN01 or a placebo through IV to compare safety and effectiveness.

What are the potential side effects?

While specific side effects are not listed here, antibodies like LASN01 can cause immune reactions, infusion-related discomforts, allergic responses, and may affect how other organs function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have Graves' disease with active thyroid eye disease.

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I have moderate-to-severe active thyroid eye disease.

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My TED symptoms started less than a year ago.

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I have not had eye surgery on the eye being studied.

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I have never had radiation therapy to my eye area.

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I am a man who is either surgically sterile or willing to use effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have experienced significant vision loss or changes due to optic nerve issues in the last 6 months.

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I have used anti-IGF-1R monoclonal antibody treatment before.

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I haven't taken biotin or multivitamins with biotin for 2 days before any lab tests.

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I have not had, nor plan to have, eye radiation or surgery for TED during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)Experimental Treatment1 Intervention

Group II: Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)Experimental Treatment1 Intervention

Group III: Open-label high dose LASN01 (post-teprotumumab, US only)Experimental Treatment1 Intervention

Group IV: Randomized placebo (anti-IGF-1R-naïve TED)Placebo Group1 Intervention

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Graves' Ophthalmopathy, also known as Thyroid Eye Disease (TED), is commonly treated with medications that target the immune system to reduce inflammation and autoimmunity. Treatments include glucocorticoids, which inhibit peripheral conversion of T4 to T3 and reduce thyroid secretion, and monoclonal antibodies like teprotumumab, which target the IGF-1 receptor to reduce inflammation and tissue expansion behind the eyes. The novel treatment LASN01, an IL-11 receptor antagonist, aims to block the IL-11 pathway, potentially reducing inflammation and fibrosis in the orbital tissues. Understanding these mechanisms is crucial for patients as it helps them comprehend how these treatments can alleviate symptoms, prevent disease progression, and improve quality of life by targeting specific pathways involved in the disease process.