A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis

JRCT ID: jRCT2031210110

Registered date:25/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic Rhinosinusitis With Nasal Polyps
• Date of first enrollment: 26/05/2021
• Target sample size: 30
• Countries of recruitment: United Staes,Japan,Canada,Japan,China,Japan,Danmark,Japan,Germany,Japan,Hungary,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

TezepelumabTezepelumab (administered via subcutaneous injection over a 52-week treatment period)
Placebo (administered via subcutaneous injection over a 52-week treatment period), Placebo

Outcome(s)

Primary Outcome

- Nasal Polyp Score [ Time Frame: Baseline to Week 52 ]
Change from baseline in total Nasal Polyp Score at Week 52. The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy.

- Participant Reported Nasal Congestion [ Time Frame: Baseline to Week 52 ]
Change from baseline in Nasal Congestion score evaluated as part of the Nasal Polyposis Symptom Diary at Week 52. Nasal Congestion Score is captured by asking participants to rate the severity of their worst nasal congestion over the past 24 hours (0-None; 1-Mild; 2-Moderate; 3-Severe).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have:

a. Severity consistent with need for surgery as defined by total NPS 5 or more ( 2 or more for each nostril) at screening, as determined by the central reader

b. Nasal Congestion Score (NCS) 2 or more at Visit 1

c. Ongoing documented NP symptoms over > 8 weeks prior to screening such as rhinorrhea and/or reduction/loss of smell

2. SNOT-22 total score 30 or more at screening (Visit 1)

3. Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to screening visit

4. Documented treatment with SCS (or contraindications/intolerance to) within the past 12 months and/or any history of NP surgery (or contraindications/intolerance to)

Exclude criteria

1. Any clinically important comorbidities other than asthma (e.g. active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc.) that could confound interpretation of clinical efficacy results.

2. Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.

3. Positive COVID-19 PCR test (or COVID-19 rapid test) or COVID-19 entry screening questionnaire during the screening visit. Evaluation will be based on on local standard of care as determined by current local guidelines.

4. Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure

5. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, systemic corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 and during the study period. Systemic corticosteroid use is defined as treatment with a burst of systemic corticosteroids for at least 3 consecutive days or a single IM depo-injectable dose of corticosteroids (considered equivalent to a 3-day burst of systemic corticosteroids).

6. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform) 28 days prior to date of IP administration at Visit 3 (randomisation visit).

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT04851964