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

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ClinicalTrials.gov Identifier: NCT03478930
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III Study GA39688 or GA39855. Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

Condition or disease Intervention/treatment Phase
Nasal Polyps Chronic Rhinosinusitis Drug: Omalizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Although this is an open-label study and all participants will be receiving omalizumab, in order to minimize bias in this study participants and the evaluating physicians will be blinded to treatment assignment of the previous studies (GA39688/GA39855) until all participants have either completed the study through the follow-up period (Week 76) or discontinued early from the study, the database is locked, and the study analyses are final.
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 5, 2020
Estimated Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Cohort A: Study GA39688 Omalizumab
Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Drug: Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Other Name: Xolair

Experimental: Cohort A: Study GA39688 Placebo
Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Drug: Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Other Name: Xolair

Drug: Placebo
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.

Experimental: Cohort B: Study GA39855 Omalizumab
Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Drug: Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Other Name: Xolair

Experimental: Cohort B: Study GA39855 Placebo
Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Drug: Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Other Name: Xolair

Drug: Placebo
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.




Primary Outcome Measures :
  1. Change From Baseline in Nasal Polyp Score (NPS) [ Time Frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 ]
  2. 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 ]
  3. Percentage of Participants with Adverse Events [ Time Frame: From Start to End (Weeks 24 to 76) of OLE Study ]
  4. Percentage of Participants with Adverse Events Leading to Discontinuation of Omalizumab [ Time Frame: From Start to End (Weeks 24 to 76) of OLE Study ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change From Baseline in Loss 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score [ Time Frame: Baseline, Weeks 16, 24, 36, 52, 64, and 76 ]
  7. Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in participants with comorbid asthma only) [ Time Frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 ]
  8. 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 ]
  9. Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values [ Time Frame: Baseline, Weeks 36, 52, 64, and 76 ]
    Investigators will assess the participants' clinical laboratory values (e.g., serum chemistry, hematology evaluations including complete blood count [CBC] with differential and platelet counts, and urinalysis values) at timepoints throughout this OLE study relative to the participants' values at baseline from studies GA39688/GA39855 and parameters with clinically significant changes from baseline will be reported.

  10. Minimum Serum Concentration (Cmin) of Omalizumab [ Time Frame: Predose at Weeks 36, 52, 64, and 76 ]
  11. Serum Concentration of Total Immunoglobulin E (IgE) [ Time Frame: Predose at Weeks 36, 52, 64, and 76 ]
  12. Serum Concentration of Free IgE [ Time Frame: Predose at Weeks 36, 52, 64, and 76 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478930


Contacts
Contact: Reference Study ID Number: WA40169 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03478930     History of Changes
Other Study ID Numbers: WA40169
2017-003450-16 ( EudraCT Number )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents