Efficacy and safety of benralizumab for prevention of nasal polyps recurrence following endoscopic sino-nasal surgery

Phase 1

• Conditions: asal polyposis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000195-38-AT
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-16
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Participants with bilateral sinonasal polyposis, and prior use of SCS (unless a medical contraindication) and ESS within 3 years, who have severity consistent with a need for surgery as described by:
(a)A minimum total NPS of 4 out of a maximum score of 8 (with a unilateral score of at least 1 for each nostril) at V1 as determined by the study imaging core lab,
(b)Ongoing symptoms for at least 12 weeks prior to V1 (question 11 of NPSQ);
(c)Sinonasal symptom (SNOT-22) total score = 30 at enrolment (V1)

Participant must meet the following criteria at the randomisation visit (V3):
- Completion of surgical procedures consistent with those described in the Pre randomisation Surgical Guideline
- Successful surgical polyp removal as evidenced by no visible polyps, confirmed by the Investigator
- SNOT-22 improvement greater than or equal to the MCID of 8.9 compared to the assessment prior to surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Participants with conditions or concomitant disease that makes them non-evaluable for the efficacy endpoint such as:
(a)Unilateral antrochoanal polyps
(b)Nasal septal deviation that occludes at least one nostril so as to prevent NPS scoring
(c)Current rhinitis medicamentosa
(d)Allergic fungal rhinosinusitis or allergic fungal sinusitis
(e)Nasal cavity tumours

- Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young’s syndrome, etc.

- Participants experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalisation (> 24 hrs) for treatment of asthma within 4 weeks prior to V1.
- Participants should not be randomised in case of persistent or new post-surgical infection (eg, fever or nasal muco-purulent discharge), uncontrolled pain, acute sinusitis, nasal infection, or upper respiratory infection in the 2 weeks before randomisation
- History of anaphylaxis to any biologic therapy or vaccine.
- A helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent and has not been treated with, or has failed to respond to standard of care therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified