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A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps (POLYP 2)

This study is currently recruiting participants.
Verified November 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT03280537
First Posted: September 12, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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.

Condition Intervention Phase
Nasal Polyps, Chronic Sinusitis Drug: Omalizumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Nasal Polyp Score (NPS) to Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures:
  • Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Average Daily Sense of Smell Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) of >= 0.5 (in participants with comorbid asthma only) at Week 24 [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline in Average Daily NCS at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change From Baseline in NPS at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Percentage of Participants With Reduction in the Need for Surgery by Week 24, as Defined by an NPS of <= 4 (Unilateral Score of <= 2 on Each Side) and Improvement in SNOT-22 Score of >= 8.9 [ Time Frame: Up to Week 24 ]
  • Percentage of Participants Requiring of Rescue Treatment (Systemic corticosteroid {CS} For >= 3 Consecutive Days) or Having had Surgery for Nasal Polyps through Week 24 [ Time Frame: Up to Week 24 ]
  • Percentage of Participants Requiring of Rescue Treatment (Systemic CS for >=3 Consecutive Days) Through Week 24 [ Time Frame: Up to Week 24 ]
  • Percentage of Participants Having had Surgery for Nasal Polyps Through Week 24 [ Time Frame: Up to Week 24 ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to Week 28 ]
  • Percentage of Participants With Serious Adverse Events [ Time Frame: Up to Week 28 ]
  • Percentage of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation [ Time Frame: Up to Week 28 ]
  • Percentage of Participants With Clinically Significant Change in Laboratory Values [ Time Frame: Up to Week 28 ]
  • Serum Concentration of Omalizumab at Specified Timepoints [ Time Frame: Day 1, Day 112, Day 168, Day 196 ]
  • Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints [ Time Frame: Screening (Day -35), Day 1, Day 112, Day 168, Day 196 ]

Estimated Enrollment: 120
Anticipated Study Start Date: November 16, 2017
Estimated Study Completion Date: May 10, 2019
Estimated Primary Completion Date: May 10, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 to 4 weeks.
Placebo Comparator: Placebo
Participants will receive matching placebo every 4 weeks or every 2 weeks.
Drug: Placebo
Matching placebo will be administered as an SC injection every 2 or 4 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  • 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.
  Contacts and Locations
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): NCT03280537


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

  Show 82 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03280537     History of Changes
Other Study ID Numbers: GA39855
2017-001718-28 ( EudraCT Number )
First Submitted: September 11, 2017
First Posted: September 12, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017

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