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Monoclonal Antibodies
Tezepelumab for Sinusitis with Nasal Polyps (ESSENCE Trial)
Phase 3
Recruiting
Led By Enrico Heffler, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be 18 years of age or older, at the time of signing the informed consent
Body weight of ≥ 40 kg at Visit 1
Must not have
Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease
Any clinically important pulmonary disease other than asthma that could confound interpretation of clinical CRSwNP endpoints results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see how well tezepelumab works for people with chronic sinusitis who may need surgery, with or without asthma. The study will last up to 40 weeks,
Who is the study for?
This trial is for adults with chronic rhinosinusitis and nasal polyps who are eligible for surgery, including those with asthma. Participants must be able to attend visits every four weeks for up to 40 weeks.
What is being tested?
The study tests Tezepelumab's effectiveness in reducing symptoms of chronic rhinosinusitis with nasal polyps over a treatment period of up to 24 weeks, with follow-up visits every four weeks.
What are the potential side effects?
While the specific side effects of Tezepelumab in this trial aren't listed here, common ones may include headache, sore throat, and reactions at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I weigh at least 40 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a documented allergy to fungi affecting my sinuses or central part of my nose.
Select...
I do not have significant lung issues other than asthma.
Select...
I have not had sinus surgery in the last 6 months or any that altered my nose's structure.
Select...
I was diagnosed with a worm infection in the last 6 months and haven't been treated successfully.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in nasal congestion
Change from baseline in sino-nasal symptoms
Secondary study objectives
Change from baseline in NCS
Change from baseline in NP severity
Change from baseline in NPQ score
+41 moreOther study objectives
ACQ-6 responder: proportion of participants with change since baseline in ACQ-6 of 0.5 or above
Annualised asthma exacerbation rate
Asthma related SCS daily dose
+20 moreSide effects data
From 2020 Phase 3 trial • 150 Patients • NCT0340607816%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Bronchitis bacterial
8%
Asthma
5%
Bronchitis
5%
Oral candidiasis
5%
Myalgia
4%
Headache
4%
Fall
3%
Hypertension
1%
Sinusitis
1%
Cardiac arrest
1%
Cardiac failure
1%
Supraventricular tachycardia
1%
Septic shock
1%
Incisional hernia
1%
Acute kidney injury
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Nephrolithiasis
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TezepelumabExperimental Treatment1 Intervention
Tezepelumab: Tezepelumab single dose subcutaneously injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~2430
Find a Location
Who is running the clinical trial?
FortreaIndustry Sponsor
20 Previous Clinical Trials
5,431 Total Patients Enrolled
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,252 Total Patients Enrolled
Enrico Heffler, MD, PhDPrincipal InvestigatorAssociate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital
Tanya M Laidlaw, MDPrincipal InvestigatorDirector of Translational Research in Allergy and Director of the Aspirin-Exacerbated Respiratory Disease (AERD) Centre at the Brigham and Women's Hospital.
3 Previous Clinical Trials
83 Total Patients Enrolled