Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis.
Details
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_43518F371E90
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis.
Journal
Contemporary clinical trials
ISSN
1559-2030 (Electronic)
ISSN-L
1551-7144
Publication state
Published
Issued date
12/2024
Peer-reviewed
Oui
Volume
147
Pages
107708
Language
english
Notes
Publication types: Journal Article ; Clinical Trial Protocol ; Randomized Controlled Trial ; Clinical Trial, Phase III ; Multicenter Study
Publication Status: ppublish
Publication Status: ppublish
Abstract
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory condition that interferes with normal food ingestion, negatively impacting quality of life (QoL). Treatment options include proton pump inhibitors, corticosteroids, biologics, or dietary elimination; however, ∼1/3 of patients remain insufficiently controlled. The pathogenesis of EoE involves interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab, a recombinant, humanized anti-IL-13 monoclonal antibody, significantly reduced mean esophageal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further investigation of the efficacy and safety of cendakimab in adults and adolescents with EoE in a phase 3 registrational study (NCT04753697), the design of which is presented here.
This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.
This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.
This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.
This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.
Keywords
Humans, Eosinophilic Esophagitis/drug therapy, Double-Blind Method, Adolescent, Adult, Antibodies, Monoclonal, Humanized/therapeutic use, Antibodies, Monoclonal, Humanized/administration & dosage, Antibodies, Monoclonal, Humanized/adverse effects, Quality of Life, Male, Female, Young Adult, Research Design, Dysphagia, Eosinophilic esophagitis, Esophageal diseases, Gastrointestinal diseases, IL-13 monoclonal antibody, Immune system diseases
Pubmed
Web of science
Open Access
Yes
Create date
11/10/2024 14:34
Last modification date
14/12/2024 8:25