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Reslizumab for Sinusitis
Phase 3
Waitlist Available
Led By Joshua Jacobs, MD
Research Sponsored by Joshua S. Jacobs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial is testing Reslizumab, a medication that helps reduce inflammation, to see if it is effective for people with chronic sinusitis. Chronic sinusitis is a long-term condition where the sinuses are swollen and inflamed. Reslizumab works by blocking certain proteins that cause this inflammation, aiming to reduce the swelling and improve symptoms.
Eligible Conditions
- Sinusitis
- Sinus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2014 Phase 3 trial • 489 Patients • NCT0128703938%
Asthma
16%
Upper respiratory tract infection
11%
Nasopharyngitis
9%
Sinusitis
8%
Headache
7%
Influenza
5%
Oropharyngeal pain
5%
Bronchitis
5%
Urinary tract infection
5%
Back pain
5%
Rhinitis allergic
4%
Cough
4%
Pharyngitis
2%
Dizziness
1%
Pneumonia
1%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Reslizumab 3.0 mg/kg
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ReslizumabExperimental Treatment1 Intervention
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reslizumab
FDA approved
Find a Location
Who is running the clinical trial?
Joshua S. JacobsLead Sponsor
Joshua Jacobs, MDPrincipal InvestigatorAllergy and Asthma Clinical Research
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