Chronic Rhinosinusitis With Nasal PolypsEarly Phase 1NCT05895929
The Role of IL5 in Epithelial Cell Integrity
A Early Phase 1 study testing Mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis (Diagnosis), run by Johns Hopkins University at 2 sites in United States.
Trial summary
The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Mepolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2023to 27 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell.
- (2) confirmation of the clinical symptoms by: (2a) CT scan evidence of paranasal sinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex; and
- (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.
Who cannot join
- 1. Children under the age of 18 will be excluded due to:
- possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.
- lack of complete pneumatization of the majority of paranasal sinuses
- 2. pregnant or lactating females,
- 3. prisoners,
- 4. mentally disabled
Show all 10Show fewer
- 5. persons unable to give informed consent will be contemplated for inclusion.
- 6. disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.
- 7. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery
- 8. exposure to immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21117
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are:
- To see what mepolizumab does to suppress inflammation of the human cells.
- To see what mepolizumab does to maintain barrier integrity of epithelial cells
Read the detailed description
The investigators hypothesize that anti-IL5 treatment will promote epithelial cell function by inhibition of Type 1 and innate immune mediated inflammation and epithelial-mesenchymal transition resulting from IL5 induction.
Aim 1. To test the hypothesis that anti-IL5 therapy results in inhibition of epithelial cell dysfunction including epithelial derived inflammatory responses and barrier dysfunction, the investigators will examine the effect of in vitro anti-IL5 mepolizumab exposure of human primary nasal epithelial cells from chronic rhinosinusitis with nasal polyposis on Type 1, Type 2 and innate immune inflammatory markers, and markers of epithelial cell barrier function.
Aim 2. To examine the effect of mepolizumab to broadly modulate the expression of Type 2, Type 1, Type 3, and innate immune inflammatory gene responses in human nasal airway epithelial cells, the investigators will perform high throughput RNA sequencing on IL5 primed differentiated human primary nasal epithelial cells exposed to the presence and absence of mepolizumab in vitro cell culture which are derived from patients with chronic rhinosinusitis with nasal polyposis. These studies will provide an unbiased approach to identification of biomarkers resulting from anti-IL5 treatment.
- Being tested
- Mepolizumab
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Also called Nucala
In vitro exposure of human nasal epithelial cells to mepolizumab
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab treatment arm | Experimental | Nasal epithelial cells will be exposed in vitro to mepolizumab in culture. Receives: Drug: Mepolizumab |
| Control arm | No intervention | Nasal epithelial cells will be exposed in vitro to media without mepolizumab in culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Type 1 inflammatory markers (ng/mL)
IL8 cytokine mRNA and protein expression
Measured: 0 to 48 hours
Change in Type 2 inflammatory markers (ng/mL)
IL5 and thymic stromal lymphopoietin cytokine mRNA and protein expression
Measured: 0 to 48 hours
Change in Innate immune inflammatory markers (ng/mL)
IL1 receptor mRNA and protein expression
Measured: 0 to 48 hours
Change in epithelial barrier function protein expression (ng/mL)
E-cadherin
Measured: 0 to 48 hours
Change in epithelial integrity markers (staining intensity units)
alpha-smooth muscle actin protein expression
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start5 Sep 2023
- Primary completion31 Dec 2025
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nasal epithelial cells will be exposed to defined doses of mepolizumab in vitro culture (Arm 1) or control media without mepolizumab (Arm 2)
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Jean Kim, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895929
- Sponsor's protocol ID
- IRB00363909
- Status last verified
- Jul 2026
- First submitted
- 12 May 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of IL5 in Epithelial Cell Integrity
- ClinicalTrials.gov ID
- NCT05895929
- Acronym / sponsor ID
- IRB00363909
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 9 Jun 2023 (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 goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are:
- To see what mepolizumab does to suppress inflammation of the human cells.
- To see what mepolizumab does to maintain barrier integrity of epithelial cells
Detailed description
The investigators hypothesize that anti-IL5 treatment will promote epithelial cell function by inhibition of Type 1 and innate immune mediated inflammation and epithelial-mesenchymal transition resulting from IL5 induction.
Aim 1. To test the hypothesis that anti-IL5 therapy results in inhibition of epithelial cell dysfunction including epithelial derived inflammatory responses and barrier dysfunction, the investigators will examine the effect of in vitro anti-IL5 mepolizumab exposure of human primary nasal epithelial cells from chronic rhinosinusitis with nasal polyposis on Type 1, Type 2 and innate immune inflammatory markers, and markers of epithelial cell barrier function.
Aim 2. To examine the effect of mepolizumab to broadly modulate the expression of Type 2, Type 1, Type 3, and innate immune inflammatory gene responses in human nasal airway epithelial cells, the investigators will perform high throughput RNA sequencing on IL5 primed differentiated human primary nasal epithelial cells exposed to the presence and absence of mepolizumab in vitro cell culture which are derived from patients with chronic rhinosinusitis with nasal polyposis. These studies will provide an unbiased approach to identification of biomarkers resulting from anti-IL5 treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nasal epithelial cells will be exposed to defined doses of mepolizumab in vitro culture (Arm 1) or control media without mepolizumab (Arm 2)
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab treatment arm | Experimental | Drug: MepolizumabNasal epithelial cells will be exposed in vitro to mepolizumab in culture. |
| Control arm | No intervention | –Nasal epithelial cells will be exposed in vitro to media without mepolizumab in culture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell.
- (2) confirmation of the clinical symptoms by: (2a) CT scan evidence of paranasal sinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex; and
- (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.
Key exclusion criteria (10 listed)
- 1. Children under the age of 18 will be excluded due to:
- 2. pregnant or lactating females,
- 3. prisoners,
- 4. mentally disabled
- 5. persons unable to give informed consent will be contemplated for inclusion.
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 |
|---|---|---|
| MepolizumabAlso: NucalaIn vitro exposure of human nasal epithelial cells to mepolizumab | Drug | Mepolizumab treatment arm |
Primary outcome
Change in Type 1 inflammatory markers (ng/mL)
Time frame: 0 to 48 hours
IL8 cytokine mRNA and protein expression
Change in Type 2 inflammatory markers (ng/mL)
Time frame: 0 to 48 hours
IL5 and thymic stromal lymphopoietin cytokine mRNA and protein expression
Change in Innate immune inflammatory markers (ng/mL)
Time frame: 0 to 48 hours
IL1 receptor mRNA and protein expression
Change in epithelial barrier function protein expression (ng/mL)
Time frame: 0 to 48 hours
E-cadherin
Change in epithelial integrity markers (staining intensity units)
Time frame: 0 to 48 hours
alpha-smooth muscle actin protein expression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Jean Kim, MD PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis (Diagnosis), run by Johns Hopkins University at 2 sites 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Type 1 inflammatory markers (ng/mL) (time frame: 0 to 48 hours). The study lists 5 primary outcomes in all. 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 6 Jul 2026.