Proof-of-Concept and Randomized, Placebo-Controlled Trials of an Fcrn Inhibitor, Batoclimab, for Thyroid Eye Disease.

ABSTRACT:

Context

Inhibition of the neonatal fragment crystallizable receptor (FcRn) reduces pathogenic thyrotropin receptor antibodies (TSH-R-Ab) that drive pathology in thyroid eye disease (TED).

Objective

We report the first clinical studies of an FcRn-inhibitor, batoclimab, in TED.

Design

Proof-of-concept (POC) and randomized, double-blind placebo-controlled trials.

Setting

Multicenter.

Participants

Patients with moderate-to-severe, active TED.

Intervention

In the POC trial, patients received weekly subcutaneous injections of batoclimab 680 mg for 2 weeks, followed by 340 mg for 4 weeks. In the double-blind trial, patients were randomized 2:2:1:2 to weekly batoclimab (680 mg, 340 mg, 255 mg) or placebo for 12 weeks.

Main outcome

Change from basel

SUBMITTER: Kahaly GJ 

PROVIDER: S-EPMC10655547 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature