A Phase 2 interventional study of TOUR006 - 20 MG and Placebo in Thyroid Eye Disease, sponsored by Tourmaline Bio, Inc., a Novartis Company. Active, not recruiting at 36 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Tourmaline Bio, Inc., a Novartis Company (part of Novartis) · Phase 2, Interventional, and Treatment
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.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's enrollment of 79 is above the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Tourmaline Bio, Inc., a Novartis Company is the lead sponsor of 2 studies on the registry; none are open to participants now.
First submitted before Tourmaline Bio, Inc. became part of Novartis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria are defined in the study protocol.
Exclusion Criteria:
Additional exclusion criteria are defined in the study protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: TOUR006 - 20 MG
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.
Drug: TOUR006 - 50 MG
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.
Other: Placebo
TOUR006 20 MG
Placebo
TOUR006 - 50 MG
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: PF-04236921