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Monoclonal Antibodies

lirentelimab for Eosinophilic Duodenitis

Phase 3
Waitlist Available
Research Sponsored by Allakos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 21 months
Awards & highlights

Study Summary

This trial will assess the long-term effects of a monthly dose of lirentelimab on patients with no prior medical education.

Eligible Conditions
  • Eosinophilic Duodenitis
  • Eosinophilic Gastritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
Other outcome measures
Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline
Proportion of Tissue Eosinophil Responders

Side effects data

From 2023 Phase 3 trial • 159 Patients • NCT04620811
25%
Corona virus infection
23%
Infusion related reaction
12%
Vomiting
11%
Abdominal pain
10%
Diarrhoea
10%
Arthralgia
8%
Headache
7%
Anaemia
7%
Coronavirus test positive
6%
Urinary tract infection
6%
Depression
6%
Upper respiratory tract infection
6%
Nausea
5%
Sinusitis
5%
Nasopharyngitis
4%
Gastroenteritis eosinophilic
2%
Appendicitis
2%
Hypersensitivity
1%
Leukopenia
1%
Syncope
1%
Volvulus
1%
Death
1%
Pyrexia
1%
Meningitis viral
1%
Cerebrovascular accident
1%
Radial nerve palsy
1%
Endometriosis
1%
Pelvic pain
1%
Rhinitis allergic
1%
Asthma
1%
Aortic thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 3.0 mg/kg of Lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lirentelimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
1,098 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
333 Patients Enrolled for Eosinophilic Duodenitis
Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,365 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
333 Patients Enrolled for Eosinophilic Duodenitis
Henrik Rasmussen, MD, PhDStudy DirectorAllakos Inc.
9 Previous Clinical Trials
2,095 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of research on lirentelimab?

"lirentelimab was first trialled in 2020 at the Allakos Investigational Site. So far, 4 studies have been completed while 3 more are ongoing with a large number of these taking place in Philadelphia, Pennsylvania."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"Unfortunately, this particular study is not presently recruiting patients. Although, it's important to note that the date of the last update was January 6th 2021. If you are looking for other options, there are 75 studies related to enteritis and 3 clinical trials testing lirentelimab that might be a better fit."

Answered by AI

How many people suffering from this ailment will be given the chance to try this new medication?

"Right now, this clinical trial isn't enrolling new patients. The listing was created on December 3rd 2020 but was last updated January 6th 2021. If you're interested in other trials, there are 75 studies recruiting participants with enteritis and 3 lirentelimab studies currently looking for more patients."

Answered by AI

Could I take part in this experiment if I wanted to?

"This clinical trial is admitting 170 participants, between the ages of 18 and 80 who currently have enteritis. It is important that patients also meet the following criteria: If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study., Able and willing to comply with all study procedures., Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception"

Answered by AI

Are there different research facilities within the US conducting this investigation?

"25 different medical facilities are currently enrolling patients for this trial. While a comprehensive list is available, some of the enrolment centres include Philadelphia, Chattanooga and Rochester. To help reduce burden, please try to participate at the closest location possible."

Answered by AI

Is this research unique in any way?

"Currently, there are 3 global clinical trials testing lirentelimab in over 100 cities and 1 nation. The first trial began in 2020 and was completed Phase 3 drug approval stage that year. All told, 170 individuals have participated across 4 different studies."

Answered by AI

What is the toxicity profile of lirentelimab?

"There is some evidence of lirentelimab's efficacy and multiple reports affirming its safety, so it received a score of 3."

Answered by AI

Does this research include any octogenarians?

"The age bracket for eligible patients in this trial is 18 to 80 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
2020. "An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620811.
~37 spots leftby Apr 2025
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