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A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
 
Region Sponsors
California - Northern
Genentech Inc.
Hoffmann-La Roche
 
Acronym KP IRB No.
POLYP 2 CN-17-3098
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients with Chronic Rhinosinusitis with Nasal Polyps who have had an inadequate response to standard-of-care treatments.
 
Purpose
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.
 
Detailed Description
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with CRSwNP who have had an inadequate response to standard-of-care treatments. This is a randomized study using parallel assignment and quadruple masking. Patients on the experimental arm will receive Omalizumab every 2 to 4 weeks, administered as a subcutaneous (SC) injection. Patients on the placebo comparator arm will receive a matching placebo every 2 to 4 weeks, administered as a subcutaneous (SC) injection.
 
Gender Age Limit
Male & Female 18 - 75 years
 
Inclusion Criteria
  • Age 18-75 years at time of signing Informed Consent Form.
  • 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 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, for at least 4 weeks before screening.
  • Treatment with nasal mometasone 200 micro gram twice a day (BID) (or once a day 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.
  • 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.
  • Ability to comply with the study protocol, in the investigator's judgment.
 
Exclusion Criteria
  • Known history of anaphylaxis/hypersensitivity to omalizumab.
  • Treatment with investigational drugs within 12 weeks or 5 half-lives prior to screening.
  • Treatment with monoclonal antibodies for 6 months prior to screening.
  • Current treatment with leukotriene antagonists/modifiers, unless participant has been on stable dosing of such medication for at least 1 month prior to screening.
  • Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives prior to screening.
  • Treatment with systemic corticosteroids, except when used as treatment for nasal polyposis, within 2 months prior to screening.
  • 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 within 1 month prior to screening or during the run-in period.
  • History of nasal surgery within 6 months prior to screening.
  • Uncontrolled epistaxis requiring surgical or procedural intervention within 2 months prior to screening.
  • Known or suspected diagnosis of cystic fibrosis, dyskinetic ciliary syndromes, immune deficiency syndrome, chronic granulomatous disease and granulomatous vasculitis, granulomatosis with polyangiitis, or eosinophilic granulomatous with polyangiitis.
  • Presence of antrochoanal polyps.
  • Concomitant conditions that interfere with evaluation of primary endpoint, including: 1) Nasal septal deviation, 2) Ongoing rhinitis medicamentosa, 3) Acute sinusitis, nasal infection, or upper respiratory infection during the run-in period, 4) Known or suspected invasive or expansive fungal rhinosinusitis.
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Otorhinolaryngology
  • Otorhinolaryngologic Diseases
  • Anti-Allergic Agents
  • Paranasal Sinus Diseases
  • Anti-Asthmatic Agents
  • Pathological Conditions, Anatomical
  • Chronic Rhinosinusitis
  • Respiratory System Agents
  • CRSwNP
  • Respiratory Tract Diseases
  • Nasal Polyps
  • Respiratory Tract Infections
  • Nose Diseases
  • Sinusitis
  • Omalizumab
  • Polyps
 
KP Clinical Facility
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
 
Clinical Area
  • Otorhinolaryngology


Principal Investigator:
Arif Seyal, MD
Contact Information:
- Deborah Macres
-Deborah.J.Macres@kp.org
-Roseville Medical Center-Rancho Cordova


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