Thyroid Eye DiseasePhase 2spiriTEDNCT06088979
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease
A Phase 2 study testing TOUR006 - 20 MG and TOUR006 - 50 MG in people with Thyroid Eye Disease, run by Tourmaline Bio, Inc., a Novartis Company at 36 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- TOUR006 - 20 MG and TOUR006 - 50 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 36 sitesin 11 countries
- Study dates
- 19 Feb 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 11 countries.
36 sites in 11 countries
United States15 sites
UC Hospital Sue Anschulz-Rodgers Eye Center - Site 840-101
Aurora, Colorado, 80045
Ophthalmic Consultants of Boston - Site 840-128
Boston, Massachusetts, 02114
Academy of Diabetes, Thyroid, and Endocrine - Site 840-129
El Paso, Texas, 79935
DCT Fort Worth Research Center - Site 840-133
Fort Worth, Texas, 76132
Hackensack University Medical Center - Site 840-105
Hackensack, New Jersey, 07601
Ophthalmic Plastic, Reconstructive, Orbital & Cosmetic Surgery - Site 840-123
Las Vegas, Nevada, 89144
Kahana Oculoplastic and Orbital Surgery - Site 840-112
Livonia, Michigan, 48152
Bascom Palmer Eye Institute - Site 840-115
Miami, Florida, 33136
University of West Virginia - Site 840-113
Morgantown, West Virginia, 26506
Columbia University - Site 840-125
New York, New York, 10032
Foothill Eye Institute - Site 840-116
Pasadena, California, 91107
University of California Davis Eye Center - Site 840-119
Sacramento, California, 95817
Sun Research Institute - Site 840-120
San Antonio, Texas, 78215
The Pacific Center for Oculofacial and Aesthetic Plastic Surgery - Site 840-122
San Francisco, California, 94115
Catalina Eye Care - Site 840-121
Tucson, Arizona, 85712
Brazil8 sites
Freire Pesquisa Clinica - Site 076-773
Belo Horizonte, 13334-290
UFG - Hospital de Clinicas da Universidade Federal de Goias - Site 076-762
Goiânia, 74605-050
Santa Casa de Misericordia de Porto Alegre - Site 076-767
Porto Alegre, 90020-090
Universidade Federal do Rio Grande do Sul (UFRGS) - Site 076-775
Porto Alegre, 90410-000
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul - Site 076-764
Porto Alegre, 90430-001
Centro Brasileiro de Pesquisa Clínica - Rio de Janeiro Ltd - Site 076-765
Rio de Janeiro, 22410-000
Irmandade da Santa Casa de Misericordia de Sao Paulo - Site 076-771
São Paulo, 01221-020
IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia - Site 076-761
São Paulo, 04038-032
France2 sites
CHU Angers - Site 250-252
Angers, 49933
CHU de Nantes - Hopital Nord Laennec - Site 250-251
Nantes, 44800
Italy2 sites
Azienda Ospedaliera Universitaria Federico II - Site 390-382
Naples, 80131
Azienda Ospedaliero Universitaria Pisana - Site 380-381
Pisa, 56124
Latvia2 sites
Riga East Clinical University Hospital, Clinic Bikernieki - Site 428-901
Riga, LV1006, Latvia
Ziemelkurzemes Regional Hospital - Site 428-902
Ventspils
Spain2 sites
Hospital Universitario Ramon y Cajal - Site 724-803
Madrid, 28034
Hospital Universitario Virgen Macarena - Site 724-801
Seville, 41009
New Zealand1 site
Southern Eye Specialists Ltd - Site 554-501
Christchurch, 8013
Puerto Rico1 site
University of Puerto Rico, Medical Sciences Campus - Site 630-602
San Juan, 00921
Slovakia1 site
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda - Site 703-211
Bratislava, 851 07
South Korea1 site
Seoul National University Hospital - Site 410-002
Seoul, 03080
About this study
Official title: A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants 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.
- Conditions
- Thyroid Eye Disease
- Being tested
- TOUR006 - 20 MG, Placebo, TOUR006 - 50 MG
- Keywords
- TED, Graves' Disease, Thyroid Eye Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOUR006 - 20 MGDrug
TOUR006 20 MG
PlaceboOther
Placebo
TOUR006 - 50 MGDrug
TOUR006 - 50 MG
| Study group | Role | What they receive |
|---|---|---|
| TOUR006 - 20 MG | Experimental | 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. Receives: Drug: TOUR006 - 20 MG |
| TOUR006 - 50 MG | Experimental | 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. Receives: Drug: TOUR006 - 50 MG |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 weeks
Secondary outcomes (7)
Percentage of participants achieving a proptosis response with 20mg TOUR006 administered SC every 8 weeks or 50mg TOUR006 administered SC every 8 weeks.
Measured: 72 weeks
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
Measured: 72 weeks
Percentage of participants attaining ≥1 grade decrease in diplopia.
Measured: 72 weeks
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Measured: 72 weeks
Mean change from baseline in serum trough concentration of TOUR006.
Measured: 72 weeks
Mean change from baseline in serum TSI.
Measured: 72 weeks
Percentage of participants with anti-drug antibodies.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start19 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourmaline Bio, Inc., a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Tourmaline Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088979
- Sponsor's protocol ID
- TOUR006-T01
- Other IDs
- U1111-1308-4718, 2024-514801-69-00
- Acronym
- spiriTED
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants With Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06088979
- Acronym / sponsor ID
- spiriTED / TOUR006-T01
- Conditions
- Thyroid Eye Disease
- Keywords
- TED, Graves' Disease, Thyroid Eye Disease, Exophthalmos, Eye Diseases, Thyroid Diseases, Graves' Ophthalmopathy, Hyperthyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tourmaline Bio, Inc., a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TOUR006 - 20 MG | Experimental | Drug: TOUR006 - 20 MGIn 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. |
| TOUR006 - 50 MG | Experimental | Drug: TOUR006 - 50 MGIn 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. |
| Placebo | Placebo comparator | Other: PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOUR006 - 20 MGTOUR006 20 MG | Drug | TOUR006 - 20 MG |
| PlaceboPlacebo | Other | Placebo |
| TOUR006 - 50 MGTOUR006 - 50 MG | Drug | TOUR006 - 50 MG |
Primary outcome
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
7 secondary outcomes
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
Percentage of participants attaining a complete or near complete response on the 7-point Clinical Activity Score (CAS).
Time frame: 72 weeks
Percentage of participants attaining ≥1 grade decrease in diplopia.
Time frame: 72 weeks
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Time frame: 72 weeks
Mean change from baseline in serum trough concentration of TOUR006.
Time frame: 72 weeks
Mean change from baseline in serum TSI.
Time frame: 72 weeks
Percentage of participants with anti-drug antibodies.
Time frame: 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Tourmaline Bio
36 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TOUR006 - 20 MG and TOUR006 - 50 MG in people with Thyroid Eye Disease, run by Tourmaline Bio, Inc., a Novartis Company at 36 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Brazil, France, Italy, Latvia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.