What side effects are associated with this type of intervention?

Common treatments for Graves' Ophthalmopathy, particularly those targeting inflammatory pathways, include corticosteroids, rituximab, and teprotumumab. Corticosteroids can cause side effects such as weight gain, mood swings, high blood pressure, and increased risk of infections. Rituximab, an immunomodulatory agent, may lead to infusion reactions, infections, and low blood cell counts. Teprotumumab, a newer treatment, has been associated with muscle spasms, nausea, hyperglycemia, and hearing impairment. These treatments aim to reduce inflammation and immune response, similar to the investigational agent TOUR006.

What prior FDA approvals exist?

The FDA has approved Teprotumumab (Tepezza) for the treatment of Thyroid Eye Disease (TED), also known as Graves' Ophthalmopathy. Teprotumumab is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor that targets the inflammatory pathways involved in TED. This treatment is similar to the investigational drug TOUR006, which is being studied for its anti-inflammatory and immunomodulatory effects in TED patients.

What other types of research exist?

Promising alternatives to TOUR006 for Graves' Ophthalmopathy include Teprotumumab, an IGF-1R blocking antibody, which has shown significant efficacy in reducing proptosis in TED patients. Other potential options may include various immunomodulatory agents or biologics targeting inflammatory pathways.

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Monoclonal Antibodies

TOUR006 for Thyroid Eye Disease (spiriTED Trial)

Phase 2

Recruiting

Research Sponsored by Tourmaline Bio, Inc.

Eligibility Criteria Checklist

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

Must have

Proptosis (exophthalmos) ≥3 mm above the normal range (based upon race and gender) for the study eye

Clinical diagnosis of Graves' disease associated with moderate to severe active TED

Must not have

Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests different amounts of a drug called TOUR006 in patients with active inflammation from Thyroid Eye Disease. The goal is to see if it can reduce inflammation and improve symptoms.

Who is the study for?

This trial is for adults aged 18-75 with moderate to severe active Thyroid Eye Disease (TED) linked to Graves' disease. Participants must have had TED symptoms start within the last year, a certain level of eye protrusion, and elevated thyroid stimulating immunoglobulin. Those with major illnesses or conditions that could risk their health or skew results, pregnant or breastfeeding individuals, recent systemic steroid users for non-TED conditions, and anyone who has used specific TED treatments are excluded.

What is being tested?

The study tests TOUR006 at doses of 20mg and 50mg against a placebo in patients with active inflammatory phase of TED. The drug is given as an under-the-skin injection every eight weeks. It's designed to see if TOUR006 can safely improve the condition compared to not receiving the active drug.

What are the potential side effects?

While specific side effects aren't listed here, common reactions may include irritation at the injection site, potential allergic reactions to ingredients in TOUR006, general discomfort like headaches or nausea following treatment. More serious side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My eye bulges more than 3 mm beyond what's normal for my race and gender.

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I have been diagnosed with Graves' disease and have moderate to severe eye problems.

Exclusion Criteria

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

Select...

I have never been treated with teprotumumab or drugs targeting the IGF-1 receptor.

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TOUR006 - 50 MGExperimental Treatment1 Intervention

In part A of the study, participants will receive a total of three 50 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

Group II: TOUR006 - 20 MGExperimental Treatment1 Intervention

In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

Group III: PlaceboPlacebo Group1 Intervention

In part A of the study, participants will receive a total of three Placebo subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use.

0 / 3Eligibility 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

Common treatments for Graves' Ophthalmopathy include corticosteroids, which reduce inflammation by inhibiting multiple inflammatory pathways, and immunomodulatory agents like rituximab, which targets B cells to reduce autoimmune activity. Treatments similar to TOUR006, such as anti-IL-6 or anti-TNF therapies, work by specifically targeting cytokines involved in the inflammatory process. These mechanisms are crucial for Graves' Ophthalmopathy patients as they help to reduce the inflammation and immune response that cause the characteristic eye symptoms, thereby improving quality of life and preventing further ocular damage.