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Clinical Trials and Synopses Offerings
Title: 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.
Title: 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.
Title: 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
Title: 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