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Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450083
Recruitment Status : Completed
First Posted : March 1, 2018
Results First Posted : January 22, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Benralizumab will be used in a placebo controlled randomized study to treat severe chronic rhinosinusitis with nasal polyps

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Nasal Polyps Eosinophilia Drug: Benralizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis: A Phase II Randomized Placebo Controlled Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Benralizumab treatment group
Benralizumab Active treatment group delivered subcutaneously
Drug: Benralizumab
30mg Benralizumab will be delivered subcutaneously
Other Name: Fasenra

Placebo Comparator: Placebo group
Placebo treatment group delivered subcutaneously
Drug: Placebo
Subcutaneous placebo injection




Primary Outcome Measures :
  1. Change in Nasal Polyp Score [ Time Frame: Week 5 and Week 25 ]

    Change in endoscopic nasal polyp score after 6 months of treatment. Nasal Polyp Score (NPS): the change in mean score from Screen visit (Week 5) bilateral endoscopic nasal polyp score as compared to score at end of treatment (Week 25). Higher scores indicate increase in number of polyps and/or polyp size. The score is the sum of the right and left nostril scores, as evaluated by nasal endoscopy.

    NPS score key: 0 = No visible polyps; 1 = Small amount of polypoid disease confined within the middle meatus; 2 = Multiple polyps occupying the middle meatus; 3 = Polyps extending beyond the middle meatus; 4 = Polyps completely obstructing the nasal cavity.

    Reported data is a difference in the NPS between Week 25 and Week 5.



Secondary Outcome Measures :
  1. Change in Nasal Polyp Size as Assessed by the Lund Mackay Score [ Time Frame: Week 5 and Week 25 ]

    Computed Tomography (CT) scan of the sinus was performed at screening (Week 5) and then again at the end of treatment (Week 25). Sinus CT images were obtained to determine the Lund Mackay Score (LMS), a widely used method for radiologic staging of nasal polyposis. The mean change in the LMS was determined by comparing the scores from Week 5 to Week 25. Each sinus group is graded between 0 and 2 (0: no abnormality; 1: partial opacification; 2: total opacification). The ostiomeatal complex is scored as "0" not obstructed) or "2" (obstructed). Overall score range of 0-24. Higher scores indicate progression of nasal polyposis disease.

    Reported data is a difference in the LMS between Week 25 and Week 5.


  2. Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test [ Time Frame: Treatment Week 0 and Week 20 ]
    The Sino-nasal Outcome Test (SNOT-22) is a condition-specific health-related quality of life assessment that captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions for the 2 weeks prior to completing the test. Participants completed the SNOT-22 at treatment Week 0 and at Treatment Week 20. Patients rated their symptom severity and symptom impact over the previous 2 weeks using a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of individual item scores and has a range from 0 to 110. Higher scores indicate more severe symptoms. Outcome measure data shows change in SNOT-22 scores between treatment Week 20 and Week 0.

  3. Change in The University of Pennsylvania Smell Identification Test Score [ Time Frame: Week 5 and Week 25 ]

    The University of Pennsylvania Smell Identification Test (UPSIT) is a quantitative test of olfactory function that uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets with 10 questions in each booklet on odor identification. Patients were asked to identify the odor by scratching the test area then selecting their answer using multiple-choice format that lists 4 different possible answers for each question. The mean change in the UPSIT was determined by comparing the score from Week 5 to the score in Week 25. The test is a forced-choice test meaning the patient is required to mark one of the four answers even if a smell is not perceived. Scores are based on number of correctly identified odors (score range 0 to 40). Higher scores indicate subject's ability to correctly identify odors.

    Reported data is a difference in the UPSIT score between Week 25 and Week 5.


  4. Change in Absolute Eosinophil Count [ Time Frame: Assessed at Treatment Week 0 and Week 20 ]
    Complete Blood Count (CBC) to determine change in absolute eosinophil count. Normal Range 30-300 cells/uL.

  5. Utilization of Prednisone as a Rescue Medication [ Time Frame: 20 weeks ]
    Use of Prednisone as a rescue medication during the treatment phase (week 0 through week 20) was measured in total milligrams (mg) that were taken by participant.

  6. Time to Surgery [ Time Frame: 24 weeks ]
  7. Number of Participants Who Dropped Out [ Time Frame: Up to 29 weeks ]
    Number of participants who dropped out monitored continuously throughout the study up to 29 weeks.



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:

  • Adults aged 18-75
  • Severe bilateral nasal polyps with average endoscopic score of at least 5
  • Blood eosinophil count of at least 300/ul at screening
  • At least 1000mg prednisone (or equivalent) over the previous 12 months to control symptoms
  • At least one prior nasal surgical polypectomy
  • Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
  • Female subjects: Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective Intra-uterine device (IUD) intrauterine device/ levonogestrel Intrauterine system (IUS), Depo-Provera(tm) injections, oral contraceptive, and Evra Patch(tm) or Nuvaring(tm). WOCBP must agree to use effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks after last dose of IP, and have negative serum pregnancy test result on Visit 0.
  • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of visit -1 without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
  • Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
  • All male subjects who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from Visit 0 until 16 weeks after their last dose.

Exclusion Criteria:

  • Immunosuppression other than oral steroids in the past 3 months
  • Allergen immunotherapy build up phase in the past 3 months
  • Symptomatic or untreated life threatening cardiopulmonary disorders
  • Subjects who are febrile (≥38°C; ≥100.4°F);
  • History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent when applicable was obtained. Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
  • A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
  • Pregnant or nursing
  • If female and of child-bearing potential, positive pregnancy test or failure to adhere to acceptable method of contraception (with <1% failure rate) during the study and for four months after the study.
  • Receipt of any investigational non biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer.
  • A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
  • Any other medical illness that precludes study involvement
  • Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to be enrolled.
  • Patients who are currently receiving or have previously received benralizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, reslizumab, lebrikizumab etc.) within the last 4 months or 5 half-lives whichever is longer.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
  • Receipt of live attenuated vaccines within 30 days of starting the study drug.

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): NCT03450083


Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jody Tversky, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03450083    
Other Study ID Numbers: IRB00112910
First Posted: March 1, 2018    Key Record Dates
Results First Posted: January 22, 2021
Last Update Posted: February 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Eosinophilia
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Leukocyte Disorders
Hematologic Diseases
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents