What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy include glucocorticoids, which can cause side effects such as increased blood sugar, weight gain, and osteoporosis. Rituximab, another treatment option, may lead to infusion reactions, infections, and low blood cell counts. Other immunosuppressive agents like mycophenolate mofetil can cause gastrointestinal issues, increased risk of infections, and liver toxicity. These treatments aim to reduce inflammation and immune response but come with a range of potential adverse effects that need to be managed under medical supervision.

What prior FDA approvals exist?

FDA-approved treatments for Graves' Ophthalmopathy include teprotumumab, a monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R). This drug has shown efficacy in reducing proptosis and improving the quality of life in patients with thyroid eye disease. Other treatments, such as corticosteroids and orbital radiotherapy, are also used to manage symptoms. While the mechanism of action for Lonigutamab is not specified, it is likely being studied for its potential to modulate immune responses or target specific pathways involved in the disease, similar to teprotumumab.

What other types of research exist?

Promising alternatives to Lonigutamab for Graves' Ophthalmopathy in 2024 include Teprotumumab, an IGF-1R inhibitor, and Rituximab, a CD20 monoclonal antibody. Both have shown efficacy in reducing orbital inflammation and improving symptoms in patients with Thyroid Eye Disease.

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Lonigutamab for Thyroid Eye Disease (TED Trial)

Phase 1 & 2

Recruiting

Research Sponsored by ValenzaBio, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 169

Summary

This trial is testing a new medication called lonigutamab to help people with Thyroid Eye Disease (TED). TED causes eye problems due to thyroid issues. Lonigutamab may work by reducing inflammation and other symptoms in the eyes.

Who is the study for?

This trial is for men and women aged 18-70 with Thyroid Eye Disease (TED), showing eye protrusion and active symptoms within the last 15 months. Participants must have a Clinical Activity Score of at least 4, indicating active disease. They should not have had certain treatments for TED or conditions like inflammatory bowel disease, hearing loss, optic neuropathy, diabetes with high hemoglobin A1c levels, or recent steroid use.

What is being tested?

The study tests Lonigutamab's effectiveness and safety in treating TED compared to a placebo. It's a Phase 1/2 trial where multiple doses are given to participants across various centers. The goal is to see if Lonigutamab can help reduce the severity of TED symptoms.

What are the potential side effects?

While specific side effects for Lonigutamab aren't listed here, common side effects from similar treatments may include reactions at the injection site, headaches, muscle pains, possible immune system responses affecting different organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 169 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)

Incidence and characterization of serious treatment emergent adverse events (TEAEs)

Secondary study objectives

PK profile of lonigutamab

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.

Group II: Cohort 3Experimental Treatment2 Interventions

multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.

Group III: Cohort 2Experimental Treatment2 Interventions

multiple doses of dose 2 of lonigutamab administered SC injection weekly

Group IV: Cohort 1Experimental Treatment2 Interventions

Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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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 corticosteroids, immunosuppressive agents, and monoclonal antibodies. Corticosteroids reduce inflammation and immune response, alleviating symptoms like swelling and redness. Immunosuppressive agents, such as methotrexate, inhibit the immune system to prevent further tissue damage. Monoclonal antibodies, like teprotumumab, target specific proteins involved in the disease process, such as the insulin-like growth factor-1 receptor (IGF-1R), to reduce inflammation and tissue expansion. These treatments are crucial for managing symptoms, preventing disease progression, and improving the quality of life for patients with Graves' Ophthalmopathy.