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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
spiriTED Trial Summary
This trial tests two doses of an injection to treat Thyroid Eye Disease in the active phase of the disease.
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.Check my eligibility
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.See study design
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.
spiriTED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye bulges more than 3 mm beyond what's normal for my race and gender.
Select...
I have been diagnosed with Graves' disease and have moderate to severe eye problems.
spiriTED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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).
Secondary outcome measures
Incidence of Treatment Emergent Adverse Events by severity and Serious Adverse Events through Week 72.
Mean change from baseline in serum TSI.
Mean change from baseline in serum trough concentration of TOUR006.
+4 morespiriTED 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.
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Who is running the clinical trial?
Tourmaline Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Clinical TrialsStudy DirectorTourmaline Bio
2,201 Previous Clinical Trials
888,797 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a specific demographic eligible to participate in this clinical experiment?
"In order to be considered, those affected by Graves' Ophthalmopathy must fall between 18 and 75 years of age. This clinical trial is accomodating a total of 81 individuals."
Answered by AI
Is the cut-off age for eligibility in this trial greater than 45 years?
"This research is accepting participants who are legally of age or younger than 75 years old."
Answered by AI
Is recruitment for this research program still available?
"According to the listing on clinicaltrials.gov, this medical trial is currently recruiting participants and has been since its initial launch in October 1st, 2023. The posting was last updated 11 days later on October 11th of that same year."
Answered by AI
What are the safety considerations for TOUR006 - 20 MG administration?
"With an assessment score of 2, it is clear that the safety profile for TOUR006 - 20 MG has been bolstered by evidence from Phase 2 trials. Unfortunately, there are no data currently supporting its efficacy."
Answered by AI
What is the participant capacity for this experiment?
"Affirmative. The information on clinicaltrials.gov attests that this investigation is actively searching for suitable patients. It was first put online on October 1st 2023 and has since been revised on the 11th of October, with 81 volunteers needed from one location."
Answered by AI
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