Clinical Trials

Patients often ask if they can participate in clinical trials. Many contributors to this educational resource have been the leaders in scientific advancement and commonly DIRECT the trials and enroll patients.

Important things to know about Clinical Trials

  • Clinical trials furnish medical care and the drug of interest without cost to the participant

  • Many Clinical trials are “placebo controlled” meaning that you have roughly equal chance of getting the mediation vs a placebo. HOWEVER, most trials allow a “cross over” so after the initial phase you can get the medication at no cost.

  • Clinical trials require more frequent follow up. Clinical trials follow patients very closely and monitor several parameters, so often the visits are more frequent and take longer than a regular doctor’s appointment. This is something to be aware of before starting a clinical trial.

  • Clinical trials can be for already FDA approved medications such as Tepezza or for new medications that are not yet FDA approved.

  • For more information about TED clinical trials, please contact us and a coordinator will get back to you in one or two business days.

Listing of CURRENT TED clinical Trials recruiting patients (for the most up-to-date info www.clinicaltrials.gov.)

  1. A Phase 3, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
    • Status: Active/Enrolling
    • Company: Vasaragen/ Sling
    • Eligibility Summary:
      • Diagnosis of moderate to severe TED within 1 year prior to screening visit.
      • Euthyroid or subclinical hyperthyroidism. No previous corneal decompensation, orbital irradiation, or orbital surgery.
  2. Observational Characterization of the Treatment Course of Patients With Thyroid Eye Disease
    • Status: Active/Enrolling
    • SPONSOR: Dr. Raymond Douglas, MD, PhD/A Professional Medical Corporation
    • Synopsis:
      • Patients who are diagnosed with Thyroid Eye Disease (TED) are asked to take part in the clinical research study. Subjects will receive the TED treatment that is considered to be most appropriate by the study doctor, according to their medical and disease history, and which the subject considers acceptable.
      • This is a noninterventional study which means that subjects will only be observed. No treatment, procedure, or test will be performed as part of the study. No aspect of the study is experimental.
      • The purpose of the study is to evaluate standard-of-care (SOC) treatment for TED in a real-world setting, the effectiveness of the treatment in terms of protrusion of the eyeball (proptosis), to show if the SOC treatment has any effect on eye anatomy and function and if the appearance of the subject’s eyes will change, and to evaluate the tolerability of SOC in subjects with TED.
  3. A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Moderate-To-Severe Thyroid Eye Disease
    • Status: Active/Enrolling
    • Protocol Number: GP44467
    • Company: F. Hoffmann-La Roche Ltd
    • Eligibility Summary:
      • Onset of active TED symptoms (as determined by subject records) with a diagnosis of Thyroid Eye Disease within 10 years.
      • Euthyroid with the baseline disease under control, or have mild hypo- or hyperthyroidism
      • Can not have had previous orbital irradiation or previous surgical treatment for TED
  4.  A Phase 3, Multi-center, Randomized,
    Quadruple-masked, Placebo-controlled Study of Batoclimab for
    the Treatment of Participants with Active Thyroid Eye Disease
    (TED)
    • Status: Active/Enrolling
    • Protocol Number: IMVT-1401-3201
    • Company: F. Immunovant Sciences GmbH
    • Eligibility Summary:
      • Onset of active TED symptoms (as determined by subject records) within 12 months before Baseline/Day 1
      • Euthyroid with the baseline disease under control, or have mild hypo- or hyperthyroidism
      • Can not have had previous orbital irradiation or previous surgical treatment for TED