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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ValenzaBio, Inc.

Criteria

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 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

Key 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).