This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
181
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Placebo
Proportion of Tissue Eosinophil Responders at Week 24
A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.
Time frame: At Week 24
Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Time frame: Baseline to Weeks 23 - 24
Change in Tissue Eosinophils From Baseline to Week 24
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)
Time frame: Baseline to Week 24
Subjects Achieving Mean Eosinophil Count ≤1 Cell/Hpf in 5 Highest Gastric Hpf and/or Mean Eosinophil Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)
Time frame: At Week 24
Number of Treatment Responders
Treatment responders defined by \>30% improvement in TSS at Weeks 23-24 and eosinophil count ≤4 cells/hpf in 5 gastric hpf and/or eosinophil count ≤15 cells/hpf in 3 duodenal hpf at Week 24
Time frame: Weeks 23-24 and at Week 24, respectively
Subjects Who Achieve ≥50% Reduction in TSS From Baseline to Weeks 23-24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allakos Investigational Site
Birmingham, Alabama, United States
Allakos Investigational Site
Huntsville, Alabama, United States
Allakos Investigational Site
Gilbert, Arizona, United States
Allakos Investigational Site
Phoenix, Arizona, United States
Allakos Investigational Site
Scottsdale, Arizona, United States
Allakos Investigational Site
Little Rock, Arkansas, United States
Allakos Investigational Site
Chula Vista, California, United States
Allakos Investigational Site
La Jolla, California, United States
Allakos Investigational Site
Murrieta, California, United States
Allakos Investigational Site
Oakland, California, United States
...and 50 more locations
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Time frame: At Weeks 23-24
Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Time frame: At Weeks 23-24
Percent Change in Weekly TSS Over Time Using MMRM
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Time frame: Baseline to Week 24