Targeting the CCL24 Pathway with nebokitug in Primary Sclerosing Cholangitis: Safety and Biological Activity from a Phase 2 Study
Year: 2025
Type: conference-abstract
Abstract: Introduction: Nebokitug (CM-101) is an anti-CCL24 monoclonal antibody with anti-inflammatory and antifibrotic activities.This phase 2 study aimed to assess the safety, tolerability, and biological activity of nebokitug in patients with primary sclerosing cholangitis (PSC).Methods: SPRING is a randomized, double-blind (DB), placebo-controlled trial with an open-label extension phase.Patients with large-duct PSC and ALP >1.5× ULN were randomized to receive intravenous nebokitug (10 mg/kg or 20 mg/kg) or placebo every 3 weeks for 15 weeks (five doses total).Following the DB period, eligible participants could enter a 33-week open-label treatment phase and a subsequent 15-week follow-up.The primary endpoint was safety and tolerability.Secondary endpoints included changes from baseline to week 15 in liver stiffness measurement (LSM), enhanced liver fibrosis (ELF) score, liver biochemistry, and pharmacokinetic (PK)/pharmacodynamic (PD) parameters.Biological activity and responder analyses were conducted in a prespecified subgroup with baseline LSM >8.7 kPa.Results: Seventy-six patients received at least one dose (placebo n=20; nebokitug n=56).Sixty-six patients (placebo n=16; nebokitug 10 mg/kg n=22; 20 mg/kg n=28) completed the DB period, received all five doses, and had baseline and at least one post-baseline measurement for ALP and ELF.Baseline characteristics were comparable: mean age 52 years (range 23-75), 74% male, 71% with IBD, and 72% on UDCA.Treatment-emergent
Author: Adi Mor
Language: English
Topic: Liver Diseases and Immunity
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4414966548
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