Efficacy and Safety of VB421 in Subjects With Thyroid Eye Disease (TED)

In by alicia.green

Locations
Jacksonville – Florida Eye Specialist (Southpoint)
Condition
Ophthalmology, Thyroid Eye Disease (TED)

Efficacy and Safety of VB421 in Subjects With Thyroid Eye Disease (TED)

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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)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  • Male or female, ≥18 and ≤65 years of age.
  • Proptosis defined in the study eye as ≥3 mm above normal.
  • Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye
  • Onset of active TED symptoms within 24 months prior to the baseline
  • Must agree to use highly effective contraception as specified in the protocol
Exclusion Criteria
  • Biopsy-proven or clinically suspected inflammatory bowel disease or irritable bowel syndrome.
  • Clinically significant pathology related to hearing
  • Corneal decompensation unresponsive to medical management.
  • Previous orbital irradiation (for any cause) or any previous surgical treatment for TED.
  • Subjects with diabetes or hemoglobin A1c >6.0%.
  • Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to >3 g of methylprednisolone for the treatment of TED.
  • Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed 1 g total dose in the 8 weeks prior to Screening.
  • Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor.
  • Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab and tocilizumab)
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