Locations
Jacksonville – Florida Eye Specialist (Southpoint)Condition
Ophthalmology, Thyroid Eye Disease (TED)Efficacy and Safety of VB421 in Subjects With Thyroid Eye Disease (TED)
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.govEligibility
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)