Dose escalation randomised study of efmarodocokin alfa in healthy volunteers and patients with ulcerative colitis.

ABSTRACT:

Background

The interleukin-22 cytokine (IL-22) has demonstrated efficacy in preclinical colitis models with non-immunosuppressive mechanism of action. Efmarodocokin alfa (UTTR1147A) is a fusion protein agonist that links IL-22 to the crystallisable fragment (Fc) of human IgG₄ for improved pharmacokinetic characteristics, but with a mutation to minimise Fc effector functions.

Methods

This randomised, phase 1b study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat intravenous dosing of efmarodocokin alfa in healthy volunteers (HVs; n=32) and patients with ulcerative colitis (n=24) at 30-90 µg/kg doses given once every 2 weeks or monthly (every 4 weeks) for 12 weeks (6:2 active:placebo per cohort).

Results

The most common adv

SUBMITTER: Wagner F 

PROVIDER: S-EPMC10359578 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature