A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) (ENIGMA 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04322604|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Gastritis Eosinophilic Duodenitis||Drug: lirentelimab (AK002) Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)|
|Actual Study Start Date :||June 18, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Placebo Comparator: Placebo
Experimental: 3 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
- Proportion of Responders as determined by gastric or duodenal tissue eosinophil counts [ Time Frame: At Week 24 ]A responder is a patient achieving the following peak eosinophil counts: eosinophil count ≤4 cells per hpf in 5 gastric hpf and/or eosinophil count ≤15 cells per hpf in 3 duodenal hpf.
- Mean absolute change in 6 symptom total symptom score (TSS: abdominal pain, nausea, abdominal cramping, loss of appetite, fullness before finishing a meal, and bloating ) as measured by the patient reported outcome (PRO) questionnaire. [ Time Frame: Baseline to Week 22 - 24 ]
- Percentage change in tissue eosinophils [ Time Frame: Baseline to Week 24 ]
- Proportion of patients achieving peak gastric and/or duodenal intraepithelial eosinophil count of ≤1 eosinophils/hpf [ Time Frame: At Week 24 ]
- Number of treatment responders as defined by >30% improvement in TSS and eosinophil count ≤4 cells per hpf in 5 gastric hpf and/or eosinophil count ≤15 cells per hpf in 3 duodenal hpf. [ Time Frame: Baseline to Week 24 and at Week 24, respectively. ]
- Proportion of patients who show ≥50% reduction in TSS [ Time Frame: Baseline to Weeks 22-24 ]
- Proportion of patients who show ≥70% reduction in TSS [ Time Frame: Baseline to Weeks 22-24 ]
- Percentage change in weekly TSS over time [ Time Frame: Baseline to Weeks 22-24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322604
|Contact: Henrik Rasmussen, MD, PhDfirstname.lastname@example.org|
|Study Director:||Henrik Rasmussen, MD, PhD||Allakos, Inc.|