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AK002 for Eosinophilic Gastritis (ENIGMA-SC Trial)
ENIGMA-SC Trial Summary
This trial will test if the drug lirentelimab is effective in treating eosinophilic gastritis and/or duodenitis in patients who have not responded to other treatments.
- Eosinophilic Gastritis
- Eosinophilic Duodenitis
ENIGMA-SC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 94 Patients • NCT04856891ENIGMA-SC Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there any other research projects which have used AK002?
"Currently, there are 3 ongoing clinical trials assessing AK002. 2 of these studies have reached Phase 3 while the remaining is still in an earlier stage. Although a few of the clinical trials evaluating AK002 are situated in Austin, Texas, there are a total of 181 research centres conducting investigations into AK002 across the globe."
Does age limit one's ability to participate in this research project?
"According to the requirements for this study, anyone over 18 and under 80 years old may be enrolled."
Who would be an eligible candidate to join this particular clinical trial?
"This trial is seeking 280 individuals with duodenitis that are between 18 and 80 years old. Most notably, patients must meet the following criteria: Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening., A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0-10) and a weekly average TSS of ≥10 for at least 2 weeks of screening., Subjects with inadequate or loss of response to, or who were intolerant to standard therapies for EG and/or EoD, which could include PPI, anti"
Is this a new experimental procedure?
"The development of AK002 began in 2020 with the first clinical trials. 170 patients participated in this initial study which was sponsored by Allakos Inc.. After the successful Phase 1 and 2 trials, AK002 received drug approval for Phase 3 clinical trials. Currently, there are active studies involving AK002 across 104 cities and 1 countries."
Are there any clinical trials similar to this one being conducted in Canada?
"enrollees should try to pick a site close to them from the 71 presently recruiting patients. To name a few, these sites are located in Fort Worth, Wyoming and Bay Saint Louis among other places. Reducing travel is important for those who enroll."
What is the total number of participants involved in this research project?
"That is correct, the information displayed on clinicaltrials.gov indicates that this study requires more participants. The trial was originally posted on December 1st 2021 and was last updated 9 days ago. In total, they are looking for 280 people to fill the vacant positions at 71 different locations."
What is the estimated mortality rate for patients with AK002?
"Data from prior clinical trials and patient safety reports support the use of AK002, giving it a score of 3."
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