Nasal PolypsPhase 2MARINERNCT05575037
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
A Phase 2 study testing Dupilumab in people with Nasal Polyps and Asthma, Aspirin-Induced, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-Exacerbated Respiratory Disease
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of AERD, defined as meeting the diagnostic triad with:
- History of physician-diagnosed asthma and
- History of physician-diagnosed nasal polyposis and
- History of pathognomonic reactions to aspirin or other nonselective COX inhibitors.
- Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
- Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of <34.
Show all 10Show fewer
- Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
- Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
- No current smoking (not more than one instance of smoking in the last 3 months).
- For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry.
Who cannot join
- Use of investigational drugs within 12 weeks of Screening.
- Use of any biologic agent within 4 months prior to Screening.
- Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
- History of any sinonasal surgery within 4 months prior to Screening
- Current use of zileuton
- Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed)
- Pregnant, nursing, or planning to become pregnant
- Note: Other inclusion and exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease: MARINER
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
Read the detailed description
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-Exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Being tested
- Dupilumab
- Medical subject headings
- Nasal Polyps, Asthma, Aspirin-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupilumab Prefilled Syringe [Dupixent]
8-week trial of dupilumab (an anti-IL-4a) in patients with AERD.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Subjects will receive dupilumab (300mg every-other-week for 8 weeks). Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal fluid levels of LTE4
The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden.
Measured: At Week 8 (Visit 3)
Secondary outcomes (8)
Nasal fluid levels of albumin
The nasal fluid levels of albumin will be measured at week 8 and serve as a surrogate biomarker of nasal epithelial cell integrity.
Measured: At Week 8 (Visit 3)
Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT)
Patients' sense of smell will be assessed at week 8 using the UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified)
Measured: At Week 8 (Visit 3)
Rhinoscopic Total Polyp Score (TPS)
The extent of patients' nasal polyps will be assessed at week 8 using a TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst.
Measured: At Week 8 (Visit 3)
Peak Nasal Inspiratory Flow (PNIF)
Patients' nasal congestion will be assessed at week 8 by a PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst.
Measured: At Week 8 (Visit 3)
Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22)
Quality of life will be assessed at week 8 with a SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control).
Measured: At Week 8 (Visit 3)
Lung function - Forced Expiratory Volume 1 (FEV1)
Patients' lung function will be assessed at week 8 with an FEV1.
Measured: At Week 8 (Visit 3)
Asthma control - Asthma Control Questionnaire-6 (ACQ-6)
Asthma control will be measured at week 8 with an ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control.
Measured: At Week 8 (Visit 3)
Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation
Safety will be measured by the number of treatment-related AEs and SAEs leading to dupilumab discontinuation.
Measured: At Week 8 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Aug 2023
- Primary completion30 Apr 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Laidlaw, MD, Brigham and Women's Hospital
- Investigators
- Tanya M Laidlaw, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575037
- Sponsor's protocol ID
- 2022P002407
- Other IDs
- U19AI095219
- Acronym
- MARINER
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease: MARINER
- ClinicalTrials.gov ID
- NCT05575037
- Acronym / sponsor ID
- MARINER / 2022P002407
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-Exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
Detailed description
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabSubjects will receive dupilumab (300mg every-other-week for 8 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of AERD, defined as meeting the diagnostic triad with:
- Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
- Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of <34.
- Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
- Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
Key exclusion criteria (8 listed)
- Use of investigational drugs within 12 weeks of Screening.
- Use of any biologic agent within 4 months prior to Screening.
- Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
- History of any sinonasal surgery within 4 months prior to Screening
- Current use of zileuton
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: Dupilumab Prefilled Syringe [Dupixent]8-week trial of dupilumab (an anti-IL-4a) in patients with AERD. | Drug | Dupilumab |
Primary outcome
Nasal fluid levels of LTE4
Time frame: At Week 8 (Visit 3)
The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden.
8 secondary outcomes
Nasal fluid levels of albumin
Time frame: At Week 8 (Visit 3)
Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: At Week 8 (Visit 3)
Rhinoscopic Total Polyp Score (TPS)
Time frame: At Week 8 (Visit 3)
Peak Nasal Inspiratory Flow (PNIF)
Time frame: At Week 8 (Visit 3)
Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22)
Time frame: At Week 8 (Visit 3)
Lung function - Forced Expiratory Volume 1 (FEV1)
Time frame: At Week 8 (Visit 3)
Asthma control - Asthma Control Questionnaire-6 (ACQ-6)
Time frame: At Week 8 (Visit 3)
Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation
Time frame: At Week 8 (Visit 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Nasal Polyps
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya M Laidlaw, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Nasal Polyps and Asthma, Aspirin-Induced, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal fluid levels of LTE4 (time frame: At Week 8 (Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.