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Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis

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ClinicalTrials.gov Identifier: NCT03450083
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 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

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




Primary Outcome Measures :
  1. Nasal Polyp Size [ Time Frame: 24 weeks ]
    Reduction in endoscopic nasal polyp score after 6 months of treatment


Secondary Outcome Measures :
  1. Nasal polyp size by CT [ Time Frame: 24 weeks ]

    Lund-Mackay (LM) CT scan of sinus will be used to determine nasal polyp size. Each of four sinuses are graded 0-3 on each side (total range 0-24).

    0 (no abnormality)

    1. (partial opacification) or
    2. (complete opacification)

  2. Clinical Survey [ Time Frame: 24 weeks ]
    Sino-nasal Outcome Test (SNOT-22) nasal symptoms score. 22 questions each scored 0-5 (no problem - as bad as it can be) for a total range of 0-110.

  3. Smell Test [ Time Frame: 24 weeks ]
    UPSIT smell test. 40 questions with four choices each. Number of correct answers range 0-40.

  4. Blood Test [ Time Frame: 24 weeks ]
    Complete Blood Count (CBC) to determine absolute eosinophil count. Range 30-300/uL.

  5. Rescue Medication Use [ Time Frame: Up to 24 weeks ]
    Rescue Medication Score. Rescue medications include triamcinolone twice daily, and Prednisone 20mg for five days which will be given only as needed periodically. Score ranges from 0-20. (0=none, 5=triamcinolone nasal daily, 10=triamcinolone nasal BID, 20=prednisone 20mg for five days)

  6. Time to Surgery [ Time Frame: 24 weeks ]
    Time to nasal polyp surgery. Measured in months starting after last injection.

  7. Drop Out Rate [ Time Frame: Up to 24 weeks ]
    Drop Out Rate. Calculated continuously throughout the study up to 24 weeks.



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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


Contacts
Contact: Jeanne Hoddinott, RN 410-550-8017 hoddin1@jhmi.edu
Contact: Tammy Fallis 410-550-2301

Locations
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jeanne Hoddinott, RN    410-550-8017    hoddin1@jhmi.edu   
Contact: Tammy Fallis    410-550-2301      
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03450083     History of Changes
Other Study ID Numbers: IRB00112910
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Eosinophilia
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Leukocyte Disorders
Hematologic Diseases
Disease Attributes
Pathologic Processes