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Monoclonal Antibodies
Dupilumab for Asthma (MARINER Trial)
Phase 2
Recruiting
Led By Tanya M Laidlaw, MD
Research Sponsored by Brigham and Women's Hospital
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 2 weeks (between visit 1 and visit 2) and 8 weeks (between visit 1 and visit 3)
Awards & highlights
MARINER Trial Summary
This trial will study how dupilumab can help people with AERD, a breathing disorder worsened by aspirin.
Who is the study for?
This trial is for adults with Aspirin-Exacerbated Respiratory Disease (AERD), featuring asthma, nasal polyps, and reactions to aspirin. Participants must have a BMI over 18, stable asthma without recent severe episodes, visible nasal polyps, impaired sense of smell, and be non-smokers. They should use birth control and not be on certain medications or pregnant.Check my eligibility
What is being tested?
The study tests Dupilumab's effectiveness against AERD by comparing it with a placebo. Dupilumab targets the IL4RA protein involved in inflammation. Patients are randomly assigned to receive either Dupilumab or an inactive substance to see if there's a difference in their respiratory symptoms.See study design
What are the potential side effects?
Dupilumab may cause side effects such as allergic reactions at the injection site, eye irritation or inflammation, joint pain, headache, cold sores in your mouth or throat.
MARINER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks (between visit 1 and visit 2) and 8 weeks (between visit 1 and visit 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks (between visit 1 and visit 2) and 8 weeks (between visit 1 and visit 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nasal fluid levels of LTE4
Secondary outcome measures
Asthma
Lung function - Forced Expiratory Volume 1 (FEV1)
Albumins
+5 moreOther outcome measures
Change in 22-Item Sino-Nasal Outcome Test (SNOT-22)
Asthma
Change in IgE levels
+9 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT0403336712%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
OLE Period: Dupilumab/Dupilumab
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab
MARINER Trial Design
1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Subjects will receive dupilumab (300mg every-other-week for 8 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,204 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,797 Total Patients Enrolled
Tanya M Laidlaw, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been using a nasal spray steroid every day for the last 4 weeks.I have not had sinus surgery in the last 4 months.I haven't taken any steroid pills or injections in the last 4 weeks.I am not taking more than 325 mg of aspirin daily.I am currently taking zileuton.I haven't used any biologic agents in the last 4 months.I have visible nasal polyps in both nostrils.I have not smoked more than once in the last 3 months.My asthma has been stable, with no severe attacks or hospital visits in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does one go about signing up for this clinical trial?
"This clinical trial is designed for patients that have nasal polyps and are between 18-70 years old. At the moment, there are 33 spots open for eligible participants."
Answered by AI
Are researchers still looking for participants in this clinical trial?
"The clinical trial mentioned is not recruiting patients at this time. It was first posted on November 1st, 2020 and updated for the last time on October 7th, 2020. There are 478 other trials that are actively recruiting participants."
Answered by AI
Does this research include people who are over 40 years old?
"People aged 18 to 70 who meet the other inclusion criteria specified by this trial are eligible to apply. In contrast, there are 134 trials for patients under the age of 18 and 338 for people over 65."
Answered by AI
What are the government's thoughts on Dupilumab?
"Dupilumab's safety was given a score of 2 by our team at Power. This is because, while there have been Phase 2 trials testing its safety, there is currently no data supporting its efficacy."
Answered by AI
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