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Monoclonal Antibodies

Dupilumab for Chronic Sinusitis

Phase 2
Recruiting
Led By Jody Tversky
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All male subjects who are sexually active must agree to use an acceptable method of contraception (condom or vasectomy) from V1-V16
Prior oral steroid or antibiotic use is acceptable but not required for entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous during entire length of study which is three years.
Awards & highlights

Study Summary

This trial is testing the effectiveness of a new drug for treating Chronic Rhinosinusitis, a condition characterized by inflammation of the sinuses. The study will exclude patients with nasal polyps, a common symptom of the disease.

Who is the study for?
This trial is for adults aged 18-75 with chronic sinusitis without nasal polyps, a certain level of sinus infection severity, and specific blood or allergy test results. Participants must agree to use effective contraception if applicable and can't be on certain medications or have conditions like uncontrolled asthma, immune deficiencies, recent biologic medication use, or serious illnesses.Check my eligibility
What is being tested?
The study tests the effectiveness of Dupilumab in treating chronic rhinosinusitis without nasal polyps compared to a placebo. It aims to understand how well Dupilumab works for different underlying causes of this condition by also looking at secondary outcomes.See study design
What are the potential side effects?
Dupilumab may cause side effects such as allergic reactions at the injection site, eye inflammation or irritation, joint pain, and possibly an increased risk of infections. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use contraception if I'm sexually active.
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I may or may not have taken steroids or antibiotics before.
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I am a woman over 50 and have not had a period for at least 12 months.
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I am between 18 and 75 years old and have chronic sinusitis without polyps.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous during entire length of study which is three years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous during entire length of study which is three years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SNOT-22
Secondary outcome measures
Adverse event rate
CT Score
Drop out rate rate
+4 more

Side effects data

From 2022 Phase 3 trial • 133 Patients • NCT04417894
24%
Nasopharyngitis
16%
COVID-19
10%
Upper respiratory tract infection
9%
Dermatitis atopic
6%
Blood creatine phosphokinase increased
1%
Post procedural infection
1%
Adenocarcinoma of colon
1%
Metastases to lung
1%
Dizziness
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dupilumab Q2W
Matching Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: dupilumab treatment groupExperimental Treatment1 Intervention
dupilumab treatment group
Group II: placebo groupPlacebo Group1 Intervention
placebo group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,720 Total Patients Enrolled
2 Trials studying Chronic Sinusitis
41 Patients Enrolled for Chronic Sinusitis
Jody TverskyPrincipal InvestigatorJohns Hopkins University

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04362501 — Phase 2
Chronic Sinusitis Research Study Groups: dupilumab treatment group, placebo group
Chronic Sinusitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04362501 — Phase 2
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04362501 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of dupilumab being administered in clinical trials?

"Currenty, 49 dupilumab trials are ongoing with 13 in the final stages of research. The largest concentration is located in Palo Alto, California but there are 2,602 total locations conducting studies for this medication."

Answered by AI

How many participants are currently enrolled in this research project?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical trial, which was first published on October 15th 2020, is actively seeking participants. Fifty patients are expected to be sourced from 1 centre."

Answered by AI

Who is eligible to participate in this medical experiment?

"This medical trial is enrolling 50 people aged 18-75 years old with sinusitis. To be considered, they must meet the following criteria: Females over 50 who have been amenorrheic for 12 months or more since their last exogenous hormone treatment; SNOT-22 score of at least 30; bilateral Lund-Mackay CT score of 4 and/or MLK endoscopy rating of 4; blood eosinophil count higher than 300/ul and positive skin prick test to 5 out of 30 allergens, or an eosinophil count lower than 300/ul with negative SPT results"

Answered by AI

What conditions is dupilumab employed in ameliorating?

"Dupilumab is primarily employed to treat atopic dermatitis, yet it can also assist with conditions such as corticosteroid-resistant asthma, eosinophilia and other related lung ailments."

Answered by AI

Has the US Food and Drug Administration (FDA) granted approval for dupilumab?

"Dupilumab is rated a 2 on the safety scale due to existing evidence of its security, however there are currently no reports that confirm its efficacy."

Answered by AI

Are individuals aged 25 and above being enlisted for this research?

"To be eligible to participate in this trial, potential enrollees must fall within the age range of 18 and 75. For those who do not meet these criteria, there are 21 trials for minors and 106 studies available for senior citizens."

Answered by AI

Has the scientific community ever conducted a similar research endeavor?

"Currently, there are 49 ongoing studies related to dupilumab in 436 locations spanning 43 nations. The initial investigation of this medication was launched by Sanofi in 2015 and included 880 participants; it concluded Phase 3 clinical trials approval with positive results. Since then, 2739 additional experiments have been finalized."

Answered by AI

Are there still opportunities to join this research endeavor?

"According to the clinicaltrials.gov data, this medical trial is currently recruiting participants. The research was first published on October 15th 2020 and most recently modified in October 12th 2022."

Answered by AI
~6 spots leftby Oct 2024