An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03478930
• Date of registration: 12/03/2018
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
• Scientific title: Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
• Date of first enrolment: May 9, 2018
• Target sample size: 249
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03478930
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, Finland, France, Germany, Hungary, Mexico, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ability to comply with the study protocol, in the investigator's judgment

- Participation in Study GA39688 or GA39855, including completion of endoscopy and other
assessments at Week 24, without discontinuation of study drug

- Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior
to the Week 24 visit of Study GA39688 or GA39855

- For women of childbearing potential: agreement to remain abstinent or use acceptable
contraceptive methods during the treatment period and for 60 days after the last dose
of study drug

Exclusion Criteria:

- Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855

- Serious adverse events related to study drug in Study GA39688 or GA39855 that the
investigator or Sponsor determines may jeopardize the patient's safety if he or she
continues in the study

- Uncontrolled epistaxis within Study GA39688 or GA39855

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
60 days after the last dose of omalizumab

- Any serious medical condition or abnormality in clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Nasal Polyps

Chronic Rhinosinusitis

Intervention(s)

Drug: Placebo

Drug: Omalizumab

Primary Outcome(s)

Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab [Time Frame: From Start to End (Weeks 24 to 76) of OLE Study]

Change From Baseline in Nasal Polyp Score (NPS) [Time Frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76]

Change From Baseline in Average Daily Nasal Congestion Score (NCS) [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76]

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [Time Frame: From Start to End (Weeks 24 to 52) of OLE Study]

Secondary Outcome(s)

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) [Time Frame: Baseline, Weeks 16, 24, 36, 52, 64, and 76]

Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76]

Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score [Time Frame: Baseline, Weeks 16, 24, 36, 52, 64, and 76]

Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score [Time Frame: Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76]

Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints [Time Frame: Predose at Weeks 36, 52, 64, and 76]

Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values [Time Frame: Baseline, Weeks 36, 52, 64, and 76]

Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains [Time Frame: Baseline, Weeks 16, 24, 36, 52, 64 and 76]

Change From Baseline in Average Daily Posterior Rhinorrhea Score [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76]

Change From Baseline in Loss of Sense of Smell Score [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76]

Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score [Time Frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76]

Serum Concentration of Total Immunoglobulin E (IgE) [Time Frame: Predose at Weeks 36, 52, 64, and 76]

Serum Concentration of Free IgE [Time Frame: Predose at Weeks 36, 52, 64, and 76]

Change From Baseline in Average Daily Anterior Rhinorrhea Score [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76]

Secondary ID(s)

WA40169

2017-003450-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/05/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03478930