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CLINICAL TRIALS AND SYNOPSES OFFERINGS

Title: A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease

Status: Active/Enrolling
Company: Horizon Therapeutics
Eligibility Summary:

  • Diagnosis of TED between 2-10 years prior to screening. Diagnosis of chronic(inactive) TED for at least one year prior to screening. No previous orbital irradiation, orbital decompression, strabismus surgery, or Tepezza treatment.

Title: A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients With Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

Status: Not yet enrolling
Company: Horizon Therapeutics
Eligibility Summary:

  • Initial Diagnosis of TED within 7 years prior to screening
  • Euthyroid or mild hyper- or hypothyroidism
  • No prior corneal decompensation, orbital irradiation, orbital decompression, or strabismus 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 1b, Randomized, Double-Masked, Placebo-Controlled, Multiple Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, And Clinical Efficacy of VB421 in Subjects With Thyroid Eye Disease (TED)

Protocol Number: 421-01-02
Status: Active/Enrolling
Company: ValenzaBio Inc
Eligibility Summary:

  • Onset of active TED symptoms (as determined by subject records) within 24 months before Baseline/Day 1
  • Euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism at screening.
  • Can not be a current smoker
  • Can not have had previous orbital irradiation or previous surgical treatment for TED

Clinical Trials and Synopses Offerings

Title: Multiple ascending dose (MAD) safety and preliminary efficacy study of VRDN-001 in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)

Status: Active/Enrolling
Company: Viridian
Eligibility Summary:

  • Diagnosed with Moderate to Severe TED within 1 year of screening
  • Be Euthyroid, or with only mild hyper- or hypothyroidism
  • No previous corneal decompensation, orbital irradiation or orbital surgery

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: Not yet enrolling
Company: Vasaragen/ Sling
Eligibility Summary:

  • Diagnosis of moderate to severe TED within 9 months prior to baseline visit.
  • Euthyroid or subclinical hyperthyroidism. No previous corneal decompensation, orbital irradiation, or orbital surgery.

Title: A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease

Status: Active/Enrolling
Company: Horizon Therapeutics
Eligibility Summary:

  • Diagnosis of TED between 2-10 years prior to screening. Diagnosis of chronic(inactive) TED for at least one year prior to screening. No previous orbital irradiation, orbital decompression, strabismus surgery, or Tepezza treatment.

Title: A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients With Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

Status: Not yet enrolling
Company: Horizon Therapeutics
Eligibility Summary:

  • Initial Diagnosis of TED within 7 years prior to screening
  • Euthyroid or mild hyper- or hypothyroidism
  • No prior corneal decompensation, orbital irradiation, orbital decompression, or strabismus 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 1b, Randomized, Double-Masked, Placebo-Controlled, Multiple Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, And Clinical Efficacy of VB421 in Subjects With Thyroid Eye Disease (TED)

Protocol Number: 421-01-02
Status: Active/Enrolling
Company: ValenzaBio Inc
Eligibility Summary:

  • Onset of active TED symptoms (as determined by subject records) within 24 months before Baseline/Day 1
  • Euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism at screening.
  • Can not be a current smoker
  • Can not have had previous orbital irradiation or previous surgical treatment for TED