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NCT06088979RECRUITINGIRB Ready

A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease

(spiriTED)

Sponsored by Tourmaline Bio, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 81 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.

Who Can Participate

Inclusion Criteria

Clinical diagnosis of Graves' disease associated with moderate to severe active TED
Onset of active TED symptoms within approximately 15 months
Proptosis (exophthalmos) โ‰ฅ3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye
CAS โ‰ฅ4 (on the 7-item scale) for the study eye
Presence of TSI \>130% of the normal reference standard or \>0.55 IU/L (depending on assay method) and laboratory reference ranges Additional inclusion criteria are defined in the study protocol.

Exclusion Criteria

Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor
History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TED. Previous oral steroid use with a cumulative dose of โ‰ค1g methylprednis

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

81 participants

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Age Range

18 Years - 80 Years

โšง

Gender

ALL

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Sponsor

Tourmaline Bio, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Escondido

California

Location available
View Escondido location page
TERMINATED

Pasadena

California

Location available
View Pasadena location page
RECRUITING

Sacramento

California

Location available
View Sacramento location page
RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page

๐Ÿ“ And 20 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Thyroid Eye Disease Treatment in Tucson?

Join others in Arizona exploring innovative treatment options through clinical research

Thyroid Eye Disease Treatment Options in Tucson, Arizona

If you're searching for Thyroid Eye Disease treatment in Tucson, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tucson, Escondido, Pasadena and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Thyroid Eye Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 81 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Thyroid Eye Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Thyroid Eye Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Thyroid Eye Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06088979. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.