Phase 2 Chronic Rhinosinusitis Trial, Completed (NCT03450083)

Phase 2 Chronic Rhinosinusitis Trial, Completed NCT03450083 Sponsor: Johns Hopkins University Condition: Chronic Rhinosinusitis

Printed from Voxsanity (voxsanity.com.au) — NCT03450083 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03450083) enrolled 24 people in total — 12 in the benralizumab treatment group and 12 in a placebo (dummy treatment) group. All 24 participants completed the study. The trial was measuring changes in nasal polyp burden and related symptoms over approximately six months, using several scoring tools including scans, smell tests, a symptom questionnaire, and blood tests. The reported data shows the following numbers across the groups. For the main measure — a scoring system for nasal polyp size and number seen on a camera exam (scored 0–8, where higher means more or larger polyps) — the treatment group's score changed by +0.9 and the placebo group's by +0.3, meaning both groups showed a small increase on this scale. For a CT scan-based scoring system (scored 0–24, higher meaning more blockage), the treatment group's score changed by −4.2 and the placebo group's by −1.6, meaning both groups showed a decrease. For a self-reported symptom questionnaire (scored 0–110, higher meaning worse symptoms), the treatment group's score changed by −19.2 and the placebo group's by −14.6, again showing decreases in both groups. For the smell identification test (scored 0–40, higher meaning better smell identification), the treatment group's score changed by +6.6 and the placebo group's by +4.3. For use of a steroid rescue medicine (prednisone), the reported total amounts taken were 302.5 mg in the treatment group and 297.5 mg in the placebo group. For a blood cell count measuring a particular type of immune cell (eosinophils, normal range 30–300 cells/uL), the reported figures were 678 cells/uL in the treatment group and 196.7 cells/uL in the placebo group; the data does not clarify whether these represent baseline levels or changes over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34110505) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You are between 18 and 75 years old
You have severe nasal polyps in both nostrils, confirmed by a camera examination with a score of at least 5
A blood test shows you have a higher-than-normal level of certain immune cells called eosinophils (at least 300 per microlitre)
You have taken at least 1,000mg of prednisone (or a similar steroid medication) over the past 12 months to manage your symptoms
You have had at least one previous surgery to remove nasal polyps
You are able to read, understand, and sign a consent form agreeing to take part in the study
If you are a woman who could become pregnant, you must use an effective form of birth control from when you join the study until 16 weeks after your last dose, and have a negative pregnancy test at the start
If you are a woman who cannot become pregnant (due to surgery or being post-menopausal), you may still be eligible (confirm with trial site)
If you are a sexually active man, you must agree to use contraception from the start of the study until 16 weeks after your last dose

Who may not be able to join:

You have taken medications that suppress your immune system (other than steroid tablets) in the past 3 months
You have been in the build-up phase of allergy immunotherapy (allergy shots) in the past 3 months
You have a serious, untreated heart or lung condition that affects your daily life
You currently have a fever of 38°C (100.4°F) or above
You have a history of most types of cancer, unless you finished treatment and have been in remission for at least 5 years (some types of skin cancer or cervical pre-cancer may be acceptable if treated and in remission for at least 12 months — confirm with trial site)
You have been diagnosed with a parasitic worm infection in the past 24 weeks that has not been successfully treated
You are currently pregnant or breastfeeding
You have taken part in another clinical trial involving a non-biological experimental drug within the past 30 days (or longer, depending on the drug)
You have a known immune system disorder, or have tested positive for HIV
You have tested positive for hepatitis B or C, or have a history of either condition (note: having had the hepatitis B vaccine without having the disease is generally acceptable — confirm with trial site)
You are currently receiving, or have recently received (within the past 4 months or longer), benralizumab or similar biological medicines such as mepolizumab, reslizumab, or lebrikizumab
You have previously had a severe allergic reaction (anaphylaxis) to any biological medicine or vaccine
You have received immunoglobulin or blood products within the past 30 days
You have received a live vaccine (such as MMR or yellow fever) within 30 days of starting the study drug
You have any other medical condition that the study team believes would make participation unsafe (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT03450083

Sponsor: Johns Hopkins University

Phase: Phase 2

Status: Completed

Condition: Chronic Rhinosinusitis

More information: https://clinicaltrials.gov/study/NCT03450083

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are between 18 and 75 years old
You have severe nasal polyps in both nostrils, confirmed by a camera examination with a score of at least 5
A blood test shows you have a higher-than-normal level of certain immune cells called eosinophils (at least 300 per microlitre)
You have taken at least 1,000mg of prednisone (or a similar steroid medication) over the past 12 months to manage your symptoms
You have had at least one previous surgery to remove nasal polyps
You are able to read, understand, and sign a consent form agreeing to take part in the study
If you are a woman who could become pregnant, you must use an effective form of birth control from when you join the study until 16 weeks after your last dose, and have a negative pregnancy test at the start
If you are a woman who cannot become pregnant (due to surgery or being post-menopausal), you may still be eligible (confirm with trial site)
If you are a sexually active man, you must agree to use contraception from the start of the study until 16 weeks after your last dose

Who may not be able to join:

You have taken medications that suppress your immune system (other than steroid tablets) in the past 3 months
You have been in the build-up phase of allergy immunotherapy (allergy shots) in the past 3 months
You have a serious, untreated heart or lung condition that affects your daily life
You currently have a fever of 38°C (100.4°F) or above
You have a history of most types of cancer, unless you finished treatment and have been in remission for at least 5 years (some types of skin cancer or cervical pre-cancer may be acceptable if treated and in remission for at least 12 months — confirm with trial site)
You have been diagnosed with a parasitic worm infection in the past 24 weeks that has not been successfully treated
You are currently pregnant or breastfeeding
You have taken part in another clinical trial involving a non-biological experimental drug within the past 30 days (or longer, depending on the drug)
You have a known immune system disorder, or have tested positive for HIV
You have tested positive for hepatitis B or C, or have a history of either condition (note: having had the hepatitis B vaccine without having the disease is generally acceptable — confirm with trial site)
You are currently receiving, or have recently received (within the past 4 months or longer), benralizumab or similar biological medicines such as mepolizumab, reslizumab, or lebrikizumab
You have previously had a severe allergic reaction (anaphylaxis) to any biological medicine or vaccine
You have received immunoglobulin or blood products within the past 30 days
You have received a live vaccine (such as MMR or yellow fever) within 30 days of starting the study drug
You have any other medical condition that the study team believes would make participation unsafe (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 2

Sponsor

Johns Hopkins University

Registry

ClinicalTrials.gov

Start date

1 July 2017

Est. completion

1 January 2020

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Nasal Polyp Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov