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

Phase 1b, multicenter, double-masked, placebo-controlled, randomized, MAD clinical study is designed to evaluate VB421 versus placebo in subjects with TED.

Key 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 eyeOnset of active TED symptoms within 24 months prior to the baselineMust agree to use highly effective contraception as specified in the protocolKey Exclusion Criteria:Biopsy-proven or clinically suspected inflammatory bowel disease or irritable bowel syndrome.Clinically significant pathology related to hearingCorneal 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).