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Monoclonal Antibodies

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps (POLYP 1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

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 baseline, week 24 (study days 155 to 186)

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

Eligible Conditions

Nasal Polyps
Chronic Sinusitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24 (study days 155 to 186)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24 (study days 155 to 186)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 (study days 155 to 186) for reporting.

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 Average Daily Nasal Congestion Score (NCS) at Week 24

Change From Baseline in Nasal Polyp Score (NPS) at Week 24

Secondary study objectives

Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24

Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 16

Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24

+17 more

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

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: OmalizumabExperimental Treatment1 Intervention

Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.

Group II: PlaceboPlacebo Group1 Intervention

Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

FDA approved

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