Phase 2 Chronic Rhinosinusitis Trial, Completed NCT02217332 Sponsor: Knopp Biosciences Condition: Chronic Rhinosinusitis
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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 (NCT02217332) enrolled 20 people who all received the study drug dexpramipexole. Of those 20, 13 completed the trial and 7 did not finish. The trial was measuring two main things over six months: changes in the number of a type of white blood cell called eosinophils (cells that can be elevated in certain conditions) circulating in the blood, and changes in the size of nasal polyps (growths inside the nose) as scored by a rating system. Nasal polyp size was rated from 0 to 8, where a lower number means smaller or fewer polyps. The reported data shows that after six months, eosinophil counts in the blood were, on average, 0.06 times what they were at the start — meaning the counts were much lower than at baseline (the starting point before treatment). For nasal polyp scores, the reported change from baseline after six months was 0.07 units on the 0–8 scale. A secondary measure also looked at eosinophil counts at three months, where the reported ratio to baseline was 0.05. The trial also tracked a number of monitoring measures — such as blood test values, vital signs (like blood pressure and heart rate), weight, and heart tracing (ECG) readings — and reported how many participants had values that were flagged as potentially noteworthy; small numbers of participants had such flags across various categories, with the full breakdown of individual sub-measures not separately labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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.

Phase 2 Chronic Rhinosinusitis Trial, Completed

NCT02217332
Completed Phase 2

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 70 years old
  • You are willing to use effective birth control during the study and for 1 month after the last dose (if female) or 3 months after the last dose (if male)
  • You have been officially diagnosed with chronic sinusitis with nasal polyps
  • Your medical records show a history of high levels of a type of white blood cell called eosinophils in your nose
  • A recent blood test shows your eosinophil count is above 300 cells per microlitre
  • Your nasal polyps score at least 4 out of the maximum on both sides of your nose combined (confirm with trial site)
  • You scored above 7 on a standard questionnaire about nose and sinus symptoms called the SNOT-22
  • You are currently using a steroid nasal spray or rinse at a low-to-moderate dose (confirm with trial site)

Who may not be able to join:

  • You have had an acute sinus infection, nasal infection, or any upper respiratory infection in the 2 weeks before the study starts
  • Your CT scan suggests a specific type of fungal sinus condition (confirm with trial site)
  • Your nasal septum is bent enough to fully block at least one nostril
  • You have had nasal surgery, including polyp removal, within the past 6 months
  • You have had more than 5 sinus or nasal surgeries that required general anaesthesia
  • You have had more than 2 sinus or nasal surgeries that involved changing the inner wall structure of your nose
  • You have a history of cystic fibrosis, a condition affecting how the tiny hairs in your airways work, or Kartagener's syndrome
  • You have ever been diagnosed with a parasitic infection
  • You have been hospitalised or needed emergency treatment for asthma 2 or more times in the past 12 months
  • You were hospitalised for a severe asthma attack within the past 4 weeks
  • Your lung function test shows your breathing capacity is below 60% of the normal expected level for someone your age and size
  • You have used steroid tablets or injections, or had steroids injected directly into a polyp, within the past 8 weeks, or you are likely to need them during the study
  • You have needed emergency steroid tablets for asthma or sinus flare-ups more than once in the past year
  • You have taken part in another clinical drug trial within the past 30 days or within a certain time frame based on the drug used (confirm with trial site)
  • You have received a biologic therapy (a type of targeted medicine, such as omalizumab/Xolair) within a certain recent time period (confirm with trial site)
  • You have taken a medication called zileuton (Zyflo) within the past 4 weeks
  • You have taken a medication called pramipexole (Mirapex) within the past 4 weeks
  • You have a history of cancer, including blood cancers or solid tumours (except certain fully treated and cured minor skin cancers)
  • You have a history of HIV, hepatitis B, or hepatitis C
  • You have a serious or unstable heart, liver, or kidney condition, or another significant health problem
  • You have any medical or personal situation that might prevent you from completing the study visits or following the study requirements
  • Your blood test shows a low level of a type of immune cell called neutrophils, or you have a history of having low neutrophil levels
  • Your blood test shows a very high level of a protein called IgE (above 1500 IU/ml)
  • Your kidneys are not filtering at a normal level based on a specific blood test (confirm with trial site)
  • You have a history of a heart rhythm condition called long QT syndrome or other irregular heartbeat
  • Your heart tracing (ECG) shows a prolonged QT interval at the screening stage or before your first dose
  • Your resting ECG shows certain other abnormalities that could affect how results are interpreted, including an unusually long PR interval, a wide QRS reading, or a heart rate that is too slow or too fast (confirm with trial site)
  • You are currently pregnant or breastfeeding

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.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Knopp Biosciences
Registry
ClinicalTrials.gov
Start date
1 August 2014
Est. completion
14 December 2016

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment; Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment

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