Experimental: Tezepelumab for Sinusitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Nerima-ku, Japan
Sinusitis+2 More
Experimental: Tezepelumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat chronic sinusitis.

See full description

Eligible Conditions

  • Sinusitis
  • Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Experimental: Tezepelumab will improve 6 secondary outcomes and 10 other outcomes in patients with Sinusitis. Measurement will happen over the course of Baseline to Week 52.

At Week 52
Resolution/Near Complete Resolution of Nasal Polyps (defined as maximum NPS of 1 in each nostril)
Resolution/Near Complete Resolution of Nasal Polyps (defined as maximum NPS of 1 in each nostril) and Nasal Polyposis Symptom Diary Total Symptom Score response
Baseline to Week 52
Asthma Control in Participants with Comorbid Asthma and Aspirin Exacerbated Respiratory Disease (AERD)/Nonsteroidal Anti-Inflammatory Drug Exacerbated Respiratory Disease (NSAID-ERD)
Immunogenicity anti-drug antibodies
Loss of Smell
Nasal Peak Inspiratory Flow
Nasal Polyp Score
Nasal Polyp-Quality of Life Compared with Placebo
Nasal Polyposis Symptom Diary
Nasal Polyposis Symptom Diary Total Symptom Score
Participant Reported Nasal Congestion
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) in Participants with Comorbid Asthma and Aspirin Exacerbated Respiratory Disease (AERD)/Nonsteroidal Anti-Inflammatory Drug Exacerbated Respiratory Disease (NSAID-ERD)
Serum trough concentrations
Sinus Opacification
Over 52 weeks
Systemic Corticosteroid Use
Up to Week 52
Nasal Polyposis Surgery and/or Receiving Systemic Corticosteroids for Nasal Polyposis

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Tezepelumab 210mg Q4W
Nasopharyngitis
21%
Upper respiratory tract infection
11%
Headache
8%
Bronchitis
5%
Bronchitis bacterial
5%
Urinary tract infection
4%
Influenza like illness
4%
Back pain
4%
Hypertension
4%
Sinusitis
4%
Arthralgia
4%
Gastroenteritis
3%
Asthma
3%
Rhinitis
3%
Viral upper respiratory tract infection
3%
Rhinitis allergic
3%
Pharyngitis
3%
Lumbar spinal stenosis
0%
Pulmonary embolism
0%
Malignant melanoma in situ
0%
Seizure
0%
Tendon rupture
0%
Dermatitis contact
0%
Cyanosis
0%
Abortion spontaneous
0%
Non-cardiac chest pain
0%
Covid-19
0%
Coronary artery disease
0%
Migraine
0%
Epistaxis
0%
Cardiac failure
0%
Aortic valve stenosis
0%
Spinal stenosis
0%
Coronary artery occlusion
0%
Uveitis
0%
Inguinal hernia
0%
Pancreatitis necrotising
0%
Bone cyst
0%
Atypical pneumonia
0%
Cellulitis
0%
Lower respiratory tract infection bacterial
0%
Pneumonia viral
0%
Oesophageal achalasia
0%
Tibia fracture
0%
Ulna fracture
0%
Obstruction gastric
0%
Pneumonia streptococcal
0%
Type 2 diabetes mellitus
0%
Cardiac failure congestive
0%
Pancreatitis acute
0%
Lower respiratory tract infection
0%
Pneumonia klebsiella
0%
Death
0%
Road traffic accident
0%
Colitis
0%
Hypertrophic cardiomyopathy
0%
Diverticular perforation
0%
Lung abscess
0%
Breast abscess
0%
Ventricular extrasystoles
0%
Rectal haemorrhage
0%
Cholelithiasis
0%
Cataract
0%
Influenza
0%
Squamous cell carcinoma
0%
Cholecystitis chronic
0%
Myositis
0%
Polyarthritis
0%
Endometrial cancer
0%
Vertigo positional
0%
Hip fracture
0%
Diverticulitis
0%
Gastroenteritis salmonella
0%
Diabetic ketoacidosis
0%
Colitis ischaemic
0%
Gastroenteritis viral
0%
Anaphylactic reaction
0%
Incisional hernia
0%
Cubital tunnel syndrome
0%
Eosinophilic pneumonia
0%
Umbilical hernia
0%
Anal abscess
0%
Ligament rupture
0%
Colon adenoma
0%
Herpes zoster oticus
0%
Pneumonia bacterial
0%
Osteoarthritis
0%
Squamous cell carcinoma of the oral cavity
0%
Idiopathic generalised epilepsy
0%
Transient ischaemic attack
0%
Gout
0%
Benign neoplasm of thyroid gland
0%
Basal cell carcinoma
0%
Ureterolithiasis
0%
Ligament sprain
0%
Lumbar vertebral fracture
0%
Radius fracture
0%
Prostate cancer
0%
Diabetes mellitus inadequate control
0%
Skin laceration
0%
Blood creatine phosphokinase increased
0%
Acute kidney injury
0%
Type 1 diabetes mellitus
0%
Haemorrhagic stroke
0%
Myelopathy
0%
Ovarian cyst
0%
Osteomyelitis
0%
Pneumonia
0%
Nasal polyps
0%
Thrombosis
0%
Muscle necrosis
0%
Head injury
0%
Septic shock
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03347279) in the Tezepelumab 210mg Q4W ARM group. Side effects include: Nasopharyngitis with 21%, Upper respiratory tract infection with 11%, Headache with 8%, Bronchitis with 5%, Bronchitis bacterial with 5%.

Trial Design

2 Treatment Groups

Tezepelumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Experimental: Tezepelumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Tezepelumab
Biological
Tezepelumab subcutaneous injection, in an accessorized pre-filled syringe.
Placebo
Other
Placebo subcutaneous injection, in an accessorized pre-filled syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at week 52 for reporting.

Closest Location

Research Site - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If a person has been stable on a certain treatment for 30 days prior to Visit 1, then that person is considered to be using the standard of care for treatment of CRSwNP. show original
Patients with a history of nasal polyposis exacerbation who received treatment with SCS for at least three consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 were included in the study show original
The patient has nasal congestion at their first visit. show original
The severity of the person's nasal polyps was such that they needed surgery, as determined by a central reader. show original
Symptoms that have been present for more than eight weeks prior to the screening, such as a runny nose and/or a reduced sense of smell. show original
If your SNOT-22 total score is ≥ 30 at screening (Visit 1), you may be eligible to participate in the study. show original

Patient Q&A Section

What are common treatments for sinusitis?

"Sinusitis is a common complaint and is treatable. The primary treatment used for symptoms is anti-allergic and anti-inflammatory medications such as the antihistamines, leukotriene receptor antagonists, and steroids. The common surgery performed on the nose included septoplasty and turbinate reduction, septorhinoplasty, and laceration repair of a persistent tear." - Anonymous Online Contributor

Unverified Answer

Can sinusitis be cured?

"There was no evidence that the sinusitis was cured after two months of antibiotics in this study. The authors recommend repeated evaluations without cure to exclude relapse." - Anonymous Online Contributor

Unverified Answer

What are the signs of sinusitis?

"Signs and symptoms of nasal obstruction appear about 1-2 weeks before the onset of fever or nasal discharge. People with sinusitis tend to have headache, a runny nose and a general feeling of flu-like symptoms including fatigue or muscle aches." - Anonymous Online Contributor

Unverified Answer

What causes sinusitis?

"There is no single known cause of sinusitis. The vast majority of cases are due to bacteria colonising tissues, although viral infections, chemical irritation and airway inflammation can contribute additional factors. Prevention is likely to be through better airway management (cleanliness and hygiene) and improvement in socioeconomic factors such as increased cleanliness." - Anonymous Online Contributor

Unverified Answer

How many people get sinusitis a year in the United States?

"More than half (53%) of the U.S. population has at least a one sinusitis infection a year, and this could lead to significant and troubling health consequences. One of the challenges to improving clinical care for patients with sinusitis is to understand how the general population is affected by sinusitis. This report may help in this regard." - Anonymous Online Contributor

Unverified Answer

What is sinusitis?

"Most common diseases in pediatric ENT are bacterial infections, with sinusitis being the most common presentation. The majority of pediatric ENT cases are caused by viral triggers. In children and teenagers, rhinovirus and respiratory syncytial virus are most common causes of viral infections. In more than two thirds of all children with sinusitis, an allergy is confirmed. There is substantial overlap in signs and symptoms between infectious and allergic causes." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sinusitis?

"The main cause of sinusitis is nasal obstruction (65.2%); other causes are viral (15.5%), bacterial (9.3%), fungal (4.7%) and parasitic (4.7%) respectively. Sinusitis occurs commonly in all age groups and in both sexes. In children there is more sinonasal involvement." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating sinusitis?

"To treat sinusitis, it is important to choose the correct antibiotics and use them correctly (according to patient age, the patient's general condition and any changes or side effects the patient might have). question: Does naltrexone treatment in rats attenuate ethanol-induced conditioned place preference in an inverse dose-response relationship? answer: The inverse dose-response relationship between conditioned place preference and absolute ethanol self-administration seen in untreated rats is in sharp contrast with the more usual positive relationship between ethanol self-administration in the rat and conditioned place preference. These data suggest a possible relationship between pharmacologic inhibition of NMDA receptor transmission with ethanol self-administration, and with the development of alcohol intake." - Anonymous Online Contributor

Unverified Answer

Does experimental: tezepelumab improve quality of life for those with sinusitis?

"In patients with active moderate-to-severe sinusitis treated in clinical equivalence trials, treatment with TEz improves sinus inflammation and symptoms of quality of life but does not affect lung function." - Anonymous Online Contributor

Unverified Answer

What does experimental: tezepelumab usually treat?

"There was no evidence for efficacy in tezepelumab arms, especially among patients with moderate-to-severe disease, who were predominantly receiving corticosteroid therapy but who responded to corticosteroid therapy in a subset of patients. Atezepelumab may be safe, but it is not effective." - Anonymous Online Contributor

Unverified Answer

Is experimental: tezepelumab safe for people?

"Tezepelumab is well tolerated by people with moderate to severe active chronic rhinosinusitis undergoing regular rhinosinusitis surgical intervention. Tolerance to nasal symptoms improved significantly during the study. There was no increase in serious adverse events in this group; however, further data are required to confirm these findings." - Anonymous Online Contributor

Unverified Answer

Has experimental: tezepelumab proven to be more effective than a placebo?

"The study suggests that the experimental therapy was more effective than the placebo in people with moderate-to-severe CRSwNP. There were no serious adverse events. We did not find evidence of an increase in the risk for infection or a serious adverse effect." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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