Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-75 years, inclusive, at time of signing Informed Consent Form.
  • Ability to comply with the study protocol, in the investigator's judgment.
  • Nasal polyp score (NPS) >= 5, with a unilateral score of >= 2 for each nostril, at screening (Day -35), and on Day -7.
  • Sino-Nasal Outcome Test-22 (SNOT-22) score >=20 at screening (Day -35) and at randomization (Day 1).
  • Treatment with at least nasal mometasone 200 micro gram per day, or equivalent daily dosing of nasal corticosteroid (CS), for at least 4 weeks before screening (Day -35).
  • Treatment with nasal mometasone 200 micro gram twice a day (BID) (or once a day [QD] if intolerant to twice daily) during the run-in period with an adherence rate of at least 70%.
  • Presence of nasal blockage/congestion with NCS >=2 (1-week recall) at Day -35 and an average of the daily NCS score over the 7 days prior to randomization of NCS >1 with at least one of the following symptoms prior to screening: nasal discharge (anterior/posterior nasal drip) and/or reduction or loss of smell.
  • Eligibility per the study drug dosing table
  • Willingness to maintain all background medications stable for the duration of the treatment and follow-up periods.
  • Willingness and ability to use electronic device to enter study-related information in electronic devices (electronic diary [eDiary]/electronic tablet [eTablet]).
  • Demonstration of at least 70% adherence to eDiary daily symptom assessment during run in period, with fully completed entries on at least 4 days in the week prior to randomization.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug.

Exclusion Criteria

  • Known history of anaphylaxis/hypersensitivity to omalizumab.
  • Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening (Day -35).
  • Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab) for 6 months prior to screening (Day -35).
  • Current treatment with leukotriene antagonists/modifiers, unless participant has been on stable dosing of such medication for at least 1 month prior to screening (Day -35).
  • Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives, whichever is longer, prior to screening (Day -35).
  • Treatment with systemic corticosteroids, except when used as treatment for nasal polyposis, within 2 months prior to screening (Day -35).
  • Usage of systemic CS during the run-in period. Participants requiring systemic CS during run-in may be rescreened after completing systemic CS.
  • Treatment with intranasal CS drops or CS administering devices (e.g., OptiNose device or stents) within 1 month prior to screening (Day -35) or during the run-in period.
  • History of nasal surgery (including polypectomy) within 6 months prior to screening.
  • History of sinus or nasal surgery modifying the structure of the nose such that assessment of NPS is not possible.
  • Uncontrolled epistaxis requiring surgical or procedural intervention, including nasal packing, within 2 months prior to screening.
  • Known or suspected diagnosis of cystic fibrosis, primary ciliary dyskinesia (e.g., Kartagener syndrome) or other dyskinetic ciliary syndromes, hypogammaglobulinemia or other immune deficiency syndrome, chronic granulomatous disease and granulomatous vasculitis, granulomatosis with polyangiitis (e.g., Wegener's Granulomatosis), or eosinophilic granulomatous with polyangiitis (EGPA) (e.g., Churg-Strauss syndrome).
  • Presence of antrochoanal polyps.
  • Concomitant conditions that interfere with evaluation of primary endpoint:
  • Nasal septal deviation occluding one or both nostrils.
  • Ongoing rhinitis medicamentosa.
  • Acute sinusitis, nasal infection, or upper respiratory infection during the run-in period.
  • Known or suspected invasive or expansive fungal rhinosinusitis.
  • Known HIV infection at screening.
  • Known acute and chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
  • History of myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack or a known history of a hypercoagulable disorder.
  • Active tuberculosis requiring treatment within 12 months prior to screening (Day -35).
  • Initiation of or change in allergen immunotherapy within 3 months prior to screening (Day -35) or during the run-in period.
  • Initiation of or change in aspirin desensitization within 4 months prior to screening (Day -35) or during the run-in period.
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab.
  • Current malignancy or history of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been treated or excised and is considered resolved.
  • Any serious medical condition (including but not limited to significant arrhythmia, uncontrolled hypertension, significant pulmonary disease other than asthma) or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study.
  • History of alcohol, drug, or chemical abuse within 6 months of screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Omalizumab
Participants will receive Omalizumab every 2 weeks or every 4 weeks.
  • Drug: Omalizumab
    Omalizumab will be administered as a subcutaneous (SC) injection every 2 or 4 weeks.
Placebo Comparator
Placebo
Participants will receive matching placebo every 2 weeks or every 4 weeks.
  • Drug: Placebo
    Matching placebo will be administered as a SC injection every 2 or 4 weeks.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461

More Details

NCT ID
NCT03280550
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA39688 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.