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NCT Number: NCT06088979

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Freire Pesquisa Clinica - Site 076-773, Belo Horizonte, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye
  • CAS ≥4 (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 ≤1g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED, however, is allowed if the corticosteroid was discontinued at least 6 weeks before baseline (Day 1) and completely tapered by Baseline (if applicable).
  • Systemic (oral or IV) corticosteroid use for conditions other than TED within 6 weeks of baseline (Day 1) or not completely tapered by baseline (if applicable).
  • Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
  • Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study
  • Pregnant or lactating

Additional exclusion criteria are defined in the study protocol.

Treatment and study plan

TOUR006 - 20 MG

Drug

TOUR006 20 MG

Placebo

Other

Placebo

TOUR006 - 50 MG

Drug

TOUR006 - 50 MG

Primary outcomes

  1. Percentage of participants achieving a proptosis response defined as a ≥2 mm reduction in proptosis from baseline in the study eye without deterioration [≥2 mm increase] of proptosis in the fellow eye and without need for rescue therapy/intervention).

    Time frame: 20 weeks

Secondary outcomes

  1. Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.

    Time frame: 72 weeks

  2. Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).

    Time frame: 72 weeks

  3. Percentage of participants attaining ≥1 grade decrease in diplopia.

    Time frame: 72 weeks

  4. Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.

    Time frame: 72 weeks

  5. Mean change from baseline in serum trough concentration of TOUR006.

    Time frame: 72 weeks

  6. Mean change from baseline in serum TSI.

    Time frame: 72 weeks

  7. Percentage of participants with anti-drug antibodies.

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Tourmaline Bio, Inc., a Novartis Company

Industry

Registry information

Official study title

A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease

Acronym: spiriTED

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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